BEGIN:VCALENDAR VERSION:2.0 PRODID:-//The American Association for Homeopathic Products - ECPv6.15.16//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:The American Association for Homeopathic Products X-ORIGINAL-URL:https://theaahp.org X-WR-CALDESC:Events for The American Association for Homeopathic Products REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20140309T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20141102T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20150308T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20151101T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20160313T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20161106T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20170312T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20171105T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20180311T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20181104T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20190310T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20191103T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20200308T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20201101T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20210314T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20211107T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20220313T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20221106T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20230312T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20231105T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20240310T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20241103T060000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20230627T120000 DTEND;TZID=America/New_York:20230627T130000 DTSTAMP:20260503T064707 CREATED:20230601T184613Z LAST-MODIFIED:20230608T132107Z UID:10000091-1687867200-1687870800@theaahp.org SUMMARY:AAHP Open-to-Industry Town Hall DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/aahp-open-to-industry-town-hall/ CATEGORIES:Webinar ATTACH;FMTTYPE=image/png:https://theaahp.org/wp-content/uploads/2022/12/100-years-1.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20230324T120000 DTEND;TZID=America/New_York:20230324T130000 DTSTAMP:20260503T064707 CREATED:20221221T183830Z LAST-MODIFIED:20230223T162313Z UID:10000090-1679659200-1679662800@theaahp.org SUMMARY:AAHP: 100 Years Promoting Quality\, Integrity\, and Trust in Homeopathic Medicines DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/100-years-promoting-quality-integrity-trust/ CATEGORIES:Conference Event,Webinar ATTACH;FMTTYPE=image/png:https://theaahp.org/wp-content/uploads/2022/12/100-years-1.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20230316T110000 DTEND;TZID=America/New_York:20230316T123000 DTSTAMP:20260503T064708 CREATED:20221220T193835Z LAST-MODIFIED:20230303T140804Z UID:10000089-1678964400-1678969800@theaahp.org SUMMARY:AAHP Annual Membership Meeting DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/annual-membership-meeting/ CATEGORIES:Webinar ATTACH;FMTTYPE=image/jpeg:https://theaahp.org/wp-content/uploads/2022/12/AdobeStock_322739387-scaled.jpeg END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20221013T140000 DTEND;TZID=America/New_York:20221013T153000 DTSTAMP:20260503T064708 CREATED:20220906T155059Z LAST-MODIFIED:20220916T130552Z UID:10000088-1665669600-1665675000@theaahp.org SUMMARY:AAHP Semiannual Membership Meeting 2022 DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/aahp-semiannual-membership-meeting-2022/ CATEGORIES:Conference Event,Webinar ATTACH;FMTTYPE=image/png:https://theaahp.org/wp-content/uploads/2022/09/zoom-call.png END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20220929 DTEND;VALUE=DATE:20220930 DTSTAMP:20260503T064708 CREATED:20211201T154229Z LAST-MODIFIED:20230712T160257Z UID:10000085-1664409600-1664495999@theaahp.org SUMMARY:Industry Reception\, Award Presentation\, and Dinner DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/aahp-industry-reception-and-award-presentation-22/ LOCATION:The Union League of Philadelphia\, 1450 Sansom St\, Philadelphia\, PA\, 19102\, United States CATEGORIES:Conference Event,Webinar ATTACH;FMTTYPE=image/jpeg:https://theaahp.org/wp-content/uploads/2021/12/iStock-926357536-1.jpg END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20220625 DTEND;VALUE=DATE:20220626 DTSTAMP:20260503T064708 CREATED:20220125T150029Z LAST-MODIFIED:20220615T180605Z UID:10000086-1656115200-1656201599@theaahp.org SUMMARY:HRI Online 2022: Key Collaborations in Homeopathy Research DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/hri-online-2022-key-collaborations-in-homeopathy-research/ CATEGORIES:Webinar ATTACH;FMTTYPE=image/jpeg:https://theaahp.org/wp-content/uploads/2022/06/Resources-scaled.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20220608T120000 DTEND;TZID=America/New_York:20220608T123000 DTSTAMP:20260503T064708 CREATED:20220408T152022Z LAST-MODIFIED:20230208T191551Z UID:10000087-1654689600-1654691400@theaahp.org SUMMARY:What's New in the HPUS and What's Coming? DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/whats-new-in-the-hpus-and-whats-coming/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20220323 DTEND;VALUE=DATE:20220324 DTSTAMP:20260503T064708 CREATED:20211130T182543Z LAST-MODIFIED:20220304T213303Z UID:10000084-1647993600-1648079999@theaahp.org SUMMARY:AAHP Annual Membership Meeting DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/aahp-annual-membership-meeting-2/ CATEGORIES:Meeting,Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20211210T120000 DTEND;TZID=America/New_York:20211210T123000 DTSTAMP:20260503T064708 CREATED:20211124T144823Z LAST-MODIFIED:20211202T153118Z UID:10000083-1639137600-1639139400@theaahp.org SUMMARY:AAHP Webinar: Annual Reporting of Quality of Listing Drugs Manufactured DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/aahp-webinar-annual-reporting-of-quality-of-listing-drugs-manufactured/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20211110T120000 DTEND;TZID=America/New_York:20211110T160000 DTSTAMP:20260503T064708 CREATED:20211004T160047Z LAST-MODIFIED:20211118T183106Z UID:10000082-1636545600-1636560000@theaahp.org SUMMARY:EAS GMP Compliance Seminar DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/eas-gmp-compliance-seminar/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20210506T130000 DTEND;TZID=America/New_York:20210506T140000 DTSTAMP:20260503T064708 CREATED:20210129T203558Z LAST-MODIFIED:20210413T130634Z UID:10000078-1620306000-1620309600@theaahp.org SUMMARY:2020-21 HPUS Update Webinar DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/2021-hpus-update/ CATEGORIES:Meeting,Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20210304T143000 DTEND;TZID=America/New_York:20210304T153000 DTSTAMP:20260503T064708 CREATED:20210108T203514Z LAST-MODIFIED:20210226T173451Z UID:10000077-1614868200-1614871800@theaahp.org SUMMARY:State of Research for Homeopathy DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/state-of-research-for-homeopathy/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20210304T123000 DTEND;TZID=America/New_York:20210304T134500 DTSTAMP:20260503T064708 CREATED:20210108T202430Z LAST-MODIFIED:20210226T173430Z UID:10000076-1614861000-1614865500@theaahp.org SUMMARY:AAHP Annual Membership Meeting DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/aahp-annual-membership-meeting/ CATEGORIES:Meeting,Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20210209T130000 DTEND;TZID=America/New_York:20210209T140000 DTSTAMP:20260503T064708 CREATED:20210106T150730Z LAST-MODIFIED:20210121T143303Z UID:10000075-1612875600-1612879200@theaahp.org SUMMARY:Poison Control in 2021: A Complimentary Informational Webinar for Homeopathic Product Safety Stakeholders DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/poison-control-in-2021/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20200723T140000 DTEND;TZID=America/New_York:20200723T150000 DTSTAMP:20260503T064708 CREATED:20200707T144243Z LAST-MODIFIED:20210108T155835Z UID:10000045-1595512800-1595516400@theaahp.org SUMMARY:Homeopathic Shopper Panel in the Era of COVID-19 DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/shopper-panel/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20200618 DTEND;VALUE=DATE:20200619 DTSTAMP:20260503T064708 CREATED:20200601T132613Z LAST-MODIFIED:20200601T132741Z UID:10000064-1592438400-1592524799@theaahp.org SUMMARY:2019–2020 HPUS Updates DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/hpus-updates/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20190515T130000 DTEND;TZID=America/New_York:20190515T140000 DTSTAMP:20260503T064708 CREATED:20190402T225547Z LAST-MODIFIED:20190408T203512Z UID:10000072-1557925200-1557928800@theaahp.org SUMMARY:Live Webinar: 2018/2019 HPUS Updates DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/live-webinar-2018-2019-hpus-updates/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20190110T110000 DTEND;TZID=America/New_York:20190110T120000 DTSTAMP:20260503T064708 CREATED:20181130T202133Z LAST-MODIFIED:20181219T203157Z UID:10000069-1547118000-1547121600@theaahp.org SUMMARY:Live Webinar: U.S. & E.U. Regulations - The Impact of "the Other" on Your Homeopathic Business DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/live-webinar-u-s-e-u-regulations-the-impact-of-the-other-on-your-homeopathic-business/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20180516T130000 DTEND;TZID=America/New_York:20180516T140000 DTSTAMP:20260503T064708 CREATED:20180424T151916Z LAST-MODIFIED:20180424T151916Z UID:10000068-1526475600-1526479200@theaahp.org SUMMARY:Live Webinar: HPUS Updates 2017/2018 DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/live-webinar-hpus-updates-2017-2018/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20170518T130000 DTEND;TZID=America/New_York:20170518T140000 DTSTAMP:20260503T064708 CREATED:20170426T171219Z LAST-MODIFIED:20170511T180610Z UID:10000048-1495112400-1495116000@theaahp.org SUMMARY:2017 HPUS Updates: A Webinar on Homeopathic GMPs and Stability DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/2017-hpus-updates-a-webinar-on-homeopathic-gmps-and-stability/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150111 DTEND;VALUE=DATE:20180111 DTSTAMP:20260503T064708 CREATED:20140127T202949Z LAST-MODIFIED:20150123T183958Z UID:10000056-1420934400-1515628799@theaahp.org SUMMARY:Best Branding Practices Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/best-branding-practices/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150110 DTEND;VALUE=DATE:20180110 DTSTAMP:20260503T064708 CREATED:20140127T203742Z LAST-MODIFIED:20150123T183039Z UID:10000054-1420848000-1515542399@theaahp.org SUMMARY:Managing Consumer Calls: Complaints\, cGMP Compliance\, Quality and Service Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/managing-consumer-calls-complaints-cgmp-compliance-quality-and-service/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150109 DTEND;VALUE=DATE:20180109 DTSTAMP:20260503T064708 CREATED:20140127T204309Z LAST-MODIFIED:20150123T183007Z UID:10000053-1420761600-1515455999@theaahp.org SUMMARY:From Leaf to Label - Quality Throughout the Cycle -- Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/from-leaf-to-label/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150108 DTEND;VALUE=DATE:20180108 DTSTAMP:20260503T064708 CREATED:20140127T203405Z LAST-MODIFIED:20150123T182934Z UID:10000055-1420675200-1515369599@theaahp.org SUMMARY:Managing Contract Manufacturing Responsibilities and Relationships Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/managing-contract-manufacturing-responsibilities-and-relationships/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150107 DTEND;VALUE=DATE:20180108 DTSTAMP:20260503T064708 CREATED:20150123T181933Z LAST-MODIFIED:20230321T192241Z UID:10000050-1420588800-1515369599@theaahp.org SUMMARY:The Homeopathic Market – Analytical Tools for Understanding and Growth Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/the-homeopathic-market-analytical-tools-for-understanding-and-growth-webinar-archive/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150106 DTEND;VALUE=DATE:20180106 DTSTAMP:20260503T064708 CREATED:20140127T200856Z LAST-MODIFIED:20150123T182821Z UID:10000057-1420502400-1515196799@theaahp.org SUMMARY:How To Survive a Product Recall Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/how-to-survive-a-product-recall/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150105 DTEND;VALUE=DATE:20180105 DTSTAMP:20260503T064708 CREATED:20140127T200313Z LAST-MODIFIED:20150123T182729Z UID:10000058-1420416000-1515110399@theaahp.org SUMMARY:FDA Hot Topics - Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/fda-current-hot-topics/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150104 DTEND;VALUE=DATE:20180105 DTSTAMP:20260503T064709 CREATED:20140604T182228Z LAST-MODIFIED:20150123T182402Z UID:10000052-1420329600-1515110399@theaahp.org SUMMARY:Homeopathic Market – Consumer Trends and Insights Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/homeopathic-market-webinar-on-consumer-trends-and-insights/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150103 DTEND;VALUE=DATE:20180103 DTSTAMP:20260503T064709 CREATED:20140127T203828Z LAST-MODIFIED:20150123T182654Z UID:10000074-1420243200-1514937599@theaahp.org SUMMARY:Homeopathic Pharmacopeia -- 2013 Updates: What Might Affect Your Business Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/homeopathic-pharmacopeia-updates-what-changes-might-affect-your-business/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150102 DTEND;VALUE=DATE:20180103 DTSTAMP:20260503T064709 CREATED:20140127T195420Z LAST-MODIFIED:20150123T182616Z UID:10000061-1420156800-1514937599@theaahp.org SUMMARY:Homeopathic Labeling: The FDA Is Watching - Webinar Archive DESCRIPTION:EAS GMP Compliance Seminar\n\n \n\n\n \n \n cGMPs – Important Considerations of HPUS and CFR \n\n \n\n\n\n \n \n \n \n Homeopathic manufacturing sites ranked lowest on FDA’s 2019 Site Inspection Scores (SIS). Our industry was rated at 6.5 versus an average across all application types of 7.4. Although the score was affected by many first-time inspections\, the industry has work to do. \nLearn directly from two former FDA inspectors during this four-hour cGMP seminar. The event will help homeopathic manufacturers prepare for FDA enforcement by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS) and Code of Federal Regulations (CFR). \n\n \n\n\n \n \n What You'll Learn: \n\nAn overview and examples of inspection enforcement.\nRequirements for registration\, drug listing\, and mandatory updates.\nHow to design an effective Adverse Events Reporting program.\nTechniques and practices to provide compliance with manufacturing\, packaging\, holding\, and distribution regulations.\n\n\n \n\n\n \n \n \n \n \n \n \n \n\n \n OPENING KEYNOTE\n\n \n \n \n\n \n \n \n \n \n\n \n Richard (Rik) Lostritto\, PhDAssociate Director for ScienceOffice of Policy for Pharmaceutical Quality (OPPQ)Center for Drug Evaluation and Research (CDER)U.S. Food and Drug Administration (FDA) Hear Dr. Lostritto’s brief opening overview of the importance that agency places on cGMPs. He will be available briefly for questions. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees. Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously\, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy\, Biopharmaceutics Lead\, CMC Division Director (oncology\, hematology\, cardio-renal\, neurology\, and psychiatric drug products)\, Team Leader (pulmonary\, allergy\, and oncology drug products)\, and Review Chemist in several therapeutic areas. Prior to joining FDA\, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy. \n \n \n \n\n\n \n \n \n \n \n \n \n \n\n \n PRESENTERS\n\n \n \n \n\n \n \n \n \n \n\n \n Bryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLC Bryan Coleman has 30 years of experience in FDA Investigations\, pharmaceuticals\, and tobacco quality and compliance. Prior to joining EAS\, he held various management responsibilities for regulatory compliance\, multi-site quality assurance/control operations\, and FDA inspections management as a Senior Manager at Altria Client Services\, LLC and Director of Quality and Compliance at Pfizer (Wyeth) Consumer Healthcare R&D. His FDA assignments began as a chemist in the Buffalo District and later as an investigator with Baltimore District\, where he performed a wide variety of field inspections and investigations operations. He has practical industry experience implementing quality and compliance systems for pharmaceutical\, device\, dietary supplement\, and tobacco operations in both development and production environments. In addition to his civilian roles\, Mr. Coleman is a retired Colonel (Combat Engineer\, Army National Guard) who held various command and staff assignments\, culminating as the Director of Joint Operations overseeing Army and Air National Guard domestic and civil response operations. Robert FishIndependent Advisor\, Quality and Compliance Robert Fish spent 33 years with FDA\, the last six years of which as Director\, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and cGMP Regulations as they relate to pharmaceutical\, device\, and biologics manufacture. Further\, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert\, speaking at international events on FDA inspections and GMPs. Mr. Fish has served as EAS’s lead presenter on cGMPs and has helped a number of homeopathic firms with issues they have faced in the past years. \n \n \n \n\n\n\n \n \n \n \n WHEN \n\n \n\n\n \n \n Wednesday\, November 10\, 2021 \n12:00 - 4:00 p.m. EST \n\n \n\n\n \n \n WHERE \n\n \n\n\n \n \n Zoom Webinar \n\n \n\n\n \n \n PRICE \n\n \n\n\n \n \n $249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n\n \n\n\n \n \n \n Register Now\n \n\n \n\n\n \n \n For questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \n\n \n\n\n \n \n \n \n \n \n Who Should Attend? \n \n \n \n This seminar is a must-attend for domestic and foreign firms who manufacture\, label\, pack\, or hold homeopathic drug products for sale in the United States. \n\nQuality Staff\nLegal & Regulatory Staff\nProduct Leads\nProduct R&D Staff\nCompany Leaders (President/CEO)\nAnd those similarly responsible at your contract manufacturer\n\n \n \n\n \n\n\n\n \n\n\n \n \n \n \n \n \n \n \n \n \n\n \n ABOUT EAS CONSULTING GROUP\, LLC\n\n \n \n \n\n \n \n \n \n \n\n \n EAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314 EAS Consulting Group\, as part of the Certified Group of companies\, has merged with Food Safety Net Services (FSNS) to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. EAS’ network of over 200 independent advisors and consultants enables them to provide comprehensive consulting\, training\, and auditing services\, ensuring proactive regulatory and quality compliance for food\, dietary supplements\, pharmaceuticals\, medical devices\, cosmetics\, tobacco\, hemp\, and CBD. The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies\, (certified-laboratories.com)\, has created a leading\, national testing and regulatory consulting platform. EAS can assist with regulatory and quality requirements and challenges while offering access to a robust scope of testing services to meet organizations' sophisticated needs. From regulatory strategy\, auditing\, training\, FDA inspection preparation\, 483 & Warning letter remediation\, quality system implementation\, labeling compliance\, preparation of technical submissions such as GRAS\, Food Additive Petitions\, DMFs\, NDIs\, 510(k)s and more; to FSMA compliance\, expert witness services and due diligence assessments\, EAS offers the expert knowledge and experience required to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement\, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. EASConsultingGroup.com. URL:https://theaahp.org/event/homeopathic-labeling-the-fda-is-watching/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT END:VCALENDAR