BEGIN:VCALENDAR VERSION:2.0 PRODID:-//The American Association for Homeopathic Products - ECPv6.15.20//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH 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 END:VTIMEZONE BEGIN:VTIMEZONE TZID:America/Los_Angeles BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20160313T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20161106T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20170312T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20171105T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20180311T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20181104T090000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20211210T120000 DTEND;TZID=America/New_York:20211210T123000 DTSTAMP:20260418T074501 CREATED:20211124T144823Z LAST-MODIFIED:20211202T153118Z UID:10000083-1639137600-1639139400@theaahp.org SUMMARY:AAHP Webinar: Annual Reporting of Quality of Listing Drugs Manufactured DESCRIPTION:Meeting FDA’s New Annual Reporting Requirement \n \nIs your firm ready to meet its new obligation to report quantities of drugs manufactured? Is your staff prepared to provide the level of detailed information in the necessary format for submission? Are you overwhelmed with the thought of tackling this new requirement and submitting the information in the next 10 weeks? \nThe AAHP brings you a 30-minute webinar to get your company well on its way to fulfilling this task with a minimum of pain and effort. Leonard Krause (of AAHP member FDA Connect) will provide the answers to two fundamental questions: \n\nWhat is required of your company?\nHow do you submit the necessary information?\n\nMore importantly\, Leonard will provide you and your team an overview of the steps and process to comply. With the clear roadmap he provides\, your company will find this undertaking less involved and complex than it looks right now. \nThis reporting requirement applies to your company if it manufactures\, repackages\, or relabels any drug products\, including homeopathic drugs. If these production steps are done on your behalf\, your company is still responsible for assuring the reporting is done in a timely manner for your products; otherwise\, your products could be at risk. \nThe reporting requirement is easiest to fulfill when your team understands what information is needed and why; then they can best support the person(s) undertaking the actual reporting task. \nWhat You’ll Learn: \n\nHow you need to prepare your company to meet its new FDA reporting obligation\nThe steps and process needed to be in compliance\n\nBe prepared for the upcoming February 2022 submission deadline as well as the subsequent reporting deadline in May 2022. \nThis economical 30-minute virtual webinar can be an integral part of your company’s obligatory training to help fulfill your cGMP compliance requirements. \nCost is only $49. AAHP members will receive a full rebate after the webinar. \nSign up here.  As many can attend at a registered location as feasible. \nPRESENTER \nLeonard KrauseFounder and PresidentFDA Connect\, Inc.Leonard Krause\, founder and president of FDA Connect\, Inc.\, has 30 years’ experience working in the field of government compliance and market research. FDA Connect specializes in serving the homeopathic pharmaceutical industry. This Oregon-based consulting company offers electronic registration and product listing services to FDA on behalf of homeopathic and OTC drug manufacturers and marketers\, as well as product label reviews and GNP due diligence audits of CMO’s on behalf of Private Label Distributors. Contact Leonard by phoning 541-232-3030 or by emailing lkrause@fda-connect.com. \nWHEN \nFriday\, December 10 \n12:00 – 12:30 p.m. EST \nWHERE \nZoom Webinar \nPRICE \n$49 per attendee \nAAHP members will receive a full rebate after the webinar. \n Register Now \nFor questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \nWho Should Attend? \n\nManagement and staff responsible for inventory control.\nManagement and staff responsible for warehousing/shipping.\nManagement and staff responsible for overseeing sales volumes.\nManagement and staff responsible for regulatory compliance.\nSenior management assuring your company meets its regulatory obligations. 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:20260418T074501 CREATED:20211004T160047Z LAST-MODIFIED:20211118T183106Z UID:10000082-1636545600-1636560000@theaahp.org SUMMARY:EAS GMP Compliance Seminar DESCRIPTION:EAS GMP Compliance Seminar\ncGMPs – Important Considerations of HPUS and CFR \nHomeopathic 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). \nWhat 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\nOPENING KEYNOTE \nRichard (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. \nPRESENTERS \nBryan J. ColemanSenior Director for Pharmaceutical & Medical Device Consulting ServicesEAS Consulting Group\, LLCBryan 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 ComplianceRobert 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. \nWHEN \nWednesday\, November 10\, 2021 \n12:00 – 4:00 p.m. EST \nWHERE \nZoom Webinar \nPRICE \n$249 per attendee \nAAHP Members will receive a $50 rebate following the event. \n Register Now \nFor questions\, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com) \nWho Should Attend? \nThis 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\nABOUT EAS CONSULTING GROUP\, LLC \nEAS Consulting Group1700 Diagonal Road\, Suite 750Alexandria\, VA 22314EAS 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:20211001T120000 DTEND;TZID=America/New_York:20211001T130000 DTSTAMP:20260418T074501 CREATED:20210412T162545Z LAST-MODIFIED:20210930T152426Z UID:10000080-1633089600-1633093200@theaahp.org SUMMARY:AAHP Semiannual Membership Meeting DESCRIPTION:AAHP Semiannual Membership Meeting \n Exclusive to AAHP Members\, this briefing will cover the latest legal and regulatory issues from AAHP Legal Counselor Al Lorman\, Esq. as well as federal programs affecting your business from AAHP Lobbyist Pete Evich of Van Scoyoc Associates. Emerging issues and critical topics will be addressed as necessary. Additionally\, AAHP officers will provide updates on association projects. AAHP Members are encouraged to invite your government affairs team\, quality assurance team\, marketing team\, R&D team\, and CEOs. \n Who Should Attend \n \nGovernment Affairs Teams\nQuality Assurance Teams\nMarketing Teams\nR&D Teams\nCEOs\n\n Important: Please register at least one (1) hour in advance of the meeting. \nAfter your registration is approved\, you will receive a confirmation email containing information about joining the meeting. \n WHEN \n \n12:00 – 1:00 p.m. EDT \n WHERE \n \n PRICE \n \nClosed to Non-Members \n \n Members: Register Today! URL:https://theaahp.org/event/aahp-semiannual-membership-meeting/ CATEGORIES:Meeting END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20210923 DTEND;VALUE=DATE:20210924 DTSTAMP:20260418T074501 CREATED:20210412T163823Z LAST-MODIFIED:20210901T132407Z UID:10000081-1632355200-1632441599@theaahp.org SUMMARY:AAHP Industry Reception and Award Presentation DESCRIPTION:AAHP Industry Reception and Award Presentation\n In-Person and Virtual Options!\n\n Join us for this complimentary and in-person event at the historic Union League of Philadelphia\, or view it virtually. Just a 5-block walk from Natural Products Expo East and a 10-minute cab ride from Amtrak’s 30th Street Station. \n Designed to connect and support retailers who champion the industry’s products with manufacturers\, this event will present the third annual Integrative Medicine Award (previously given to trailblazers at Wegman’s and Rite Aid). Network over hors d’oeuvres and cocktails with senior executives from the homeopathic industry and professionals from adjacent associations before hearing the award winner share retail initiatives for natural products. \n FEATURING \n Bryan Gildenberg\nSenior Vice President\, Commerce\nOmnicom Commerce Group (OCG)\nBryan’s perspective has been featured on broadcast media such as CNBC\, Fox Business\, and the BBC\, and he is frequently cited in a range of U.S. and global business publications. An engaging speaker\, he has addressed thousands of industry/corporate meetings over his nearly 25-year career\, with a particular focus on health and wellness and its evolving retail landscape. Bryan is currently with OCG\, a community of best-in-class consultancy\, creativity\, and capability in retail\, shopper\, and commerce marketing\, focused on driving sales growth through increased conversion. Prior to Omnicom\, Bryan led global retail research for Kantar’s retail practice. He earned an MBA summa cum laude from Babson College and an undergraduate degree from Cambridge University in Cambridge\, England. Bryan currently works out of\, and occasionally leaves\, his home office in New Jersey. \n INTEGRATIVE MEDICINE RETAILER AWARD RECIPIENT \n Jenn Martin\nVice President\, Merchandising Health\, Beauty\, Baby Center\, Card & Party\nMeijer\nJenn Martin has worked with Meijer for nine years\, holding various merchandising roles in Health and Beauty Care and Pets since she started in 2012. Prior to joining Meijer\, Jenn spent five years with L Brands\, working in various planning functions for Victoria’s Secret and Bath and Body Works in Columbus\, Ohio and New York\, New York. She began her career by spending two years at Target Corporation in Minneapolis\, Minnesota. \n VENUE \n The Union League\nGrant West Room\, 1st Floor\n1450 Sansom Street\, Philadelphia\, PA 19102\n\n WHEN \n \nIn-Person Programming begins at 5:30 p.m. \nVirtual Programming begins at 6:00 p.m. \n PRICE \n \n \n Register Now\n \n Updated: August 12\, 2021\n COVID-19 Policy \n Effective Aug. 12\, 2020\, a new policy by the City of Philadelphia requires masks for everyone\, regardless of vaccination status\, at all Philadelphia businesses and institutions that do not enforce vaccination for employees and patrons.The Union League of Philadelphia is a fully vaccinated facility. Therefore masks are not required\, but all staff\, members\, guests\, and vendors must be vaccinated to enter the building. The Union League asks that guests have their vaccination card or a photo of their vaccination card on hand should the facility be audited. \n AGENDA \n \n\n \n \n STREAMINGTIMESPEAKERTOPICS \n \n \n No5:30 p.m.Networking over cocktails and hors d’oeuvresYes (Virtual Content Begins)6:00 p.m.Mark Land\, MS\, RAC\nPresident\, AAHPWelcome RemarksYes6:10 p.m.Bryan Gildenberg\nSenior Vice President\, Commerce \nOmnicon Commerce GroupRetail ReportYes6:30 p.m.Natalie (Hodgman) Ryan\nInsights Team Lead\nThe Emerson GroupHomeopathy’s Future at RetailYes6:35 p.m.Jenn Beatty\nTeam Lead East\nThe Emerson GroupIntroduction to AAHP AwardYes6:40 p.m.Jenn Martin \nVice President\, Merchandising Health\, Beauty\, Baby Center\, Card & Party\nMeijerAAHP Integrative Medicine Retailer Award Presentation \n\n PRESENTING SPONSOR \n \n\nThe Emerson Group is a consumer products equity organization focused on accelerating mid-market brand growth. It also operates internationally\, providing partners in the European\, South American and Asian Pacific regions with the expertise and infrastructure necessary to successfully operate in the U.S. market. An Emerson Group division\, Emerson Logistics is a consumer products logistics solutions provider. A third division\, Emerson Marketing\, is an analytics and insights-based consumer products communications organization. \n Updated: August 12\, 2021\n COVID-19 Policy \n Effective Aug. 12\, 2020\, a new policy by the City of Philadelphia requires masks for everyone\, regardless of vaccination status\, at all Philadelphia businesses and institutions that do not enforce vaccination for employees and patrons.The Union League of Philadelphia is a fully vaccinated facility. Therefore masks are not required\, but all staff\, members\, guests\, and vendors must be vaccinated to enter the building. The Union League asks that guests have their vaccination card or a photo of their vaccination card on hand should the facility be audited. \n REGISTRATION \n 2021 Industry Reception Registration\n \n \n NAME(Required)\n \n First\n \n Last\n Company(Required) Title / Responsibility(Required) Zip / Postal Code(Required) Email(Required)\n \n I will be attending…(Required)In-personVirtually(Required) I consent to add the above email to AAHP’s digital mail list to receive future event notifications and monthly newsletters.(Required) I agree to AAHP’s Photo/Video Release (link below)(Required) I agree to AAHP’s Waiver and Release of Liability for Communicable Disease (link below) URL:https://theaahp.org/event/aahp-industry-reception-and-award-presentation/ LOCATION:The Union League of Philadelphia\, 1450 Sansom St\, Philadelphia\, PA\, 19102\, United States CATEGORIES:Meeting END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20210615T130000 DTEND;TZID=America/New_York:20210615T170000 DTSTAMP:20260418T074501 CREATED:20210129T204739Z LAST-MODIFIED:20210407T145127Z UID:10000079-1623762000-1623776400@theaahp.org SUMMARY:2021 AAHP Summit: Developing HPUS Guidelines for FDA Compliance\, Part 2 DESCRIPTION: URL:https://theaahp.org/event/annual-summit/ CATEGORIES:Conference Event END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20210506T130000 DTEND;TZID=America/New_York:20210506T140000 DTSTAMP:20260418T074501 CREATED:20210129T203558Z LAST-MODIFIED:20210413T130634Z UID:10000078-1620306000-1620309600@theaahp.org SUMMARY:2020-21 HPUS Update Webinar DESCRIPTION:2020-21 HPUS Updates Webinar \n This short webinar will review additions and changes to monographs in the HPUS\, including revised attenuation levels\, and updates to quality control methods and specifications.  You will hear about the two behind-the-scenes projects the Convention has been engaged with over the past year as well as a glimpse of the status of the “technical gaps” work. \n\nAttend this half-hour webinar for an overview of these changes; attendees can receive (post-webinar) documents listing the monographs affected by these updates. \n\n  \n Who Should Attend \n \nCompliance Managers\nQuality Control and Quality Assurance Managers\nStaff Responsible for Product Formulations\nStaff Responsible for Product and Label Review\nMarketing Staff\nCEOs and Senior Management\n\n Presented By \n \nFor more 40 years\, Eric Foxman RPh has been involved with the HPCUS in many capacities\, including its Board\, and as chair of the Council on Pharmacy.  In this latter role\, Eric has helped with the review and revision of compendial documents to keep them current with contemporary cGMP expectations. \nMany in the industry know Eric Foxman as a member or company representative of the American Association of Homeopathic Pharmacists dating back to 1979. He is in the 11th year (in his fourth round) on the Board of Directors.  Eric has been a presenter or host of numerous AAHP Compliance Thru Education webinars addressing legal\, regulatory and technical aspects of the manufacture and marketing of homeopathic drug products; this is Eric’s ninth annual webinar on HPUS Updates. \n WHEN \n \n1:00 pm ET \n PRICE \n Non-Members:  $79 \n AAHP members will receive a $79 rebate for each registration after the webinar has ended. \n \n Register Now\n \n Registration Information \n \nEach Webinar registration is for one computer/phone connection.\nIf it is physically possible at your location\, more than one participant may view the live webinar with no additional registration fee.\nThe registration fee has been purposefully kept low to make it possible for multiple employees of a company to attend at separate locations.  AAHP members will receive a rebate for each registration after the webinar has ended.\nEach registration will automatically receive one (1) Certificate of participation issued in the name of the registered participant. If you would like additional certificates of participation\, please send an email to info@aahp.info to indicate how many additional certificates you wish to purchase at $39 each; you will be contacted after the event for the names to be printed on the additional certificates and to arrange for payment through PayPal.\nFor more information regarding the seminar\, call Eric Foxman (1-503-659-2715) or by email: info@aahp.info 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:20260418T074501 CREATED:20210108T203514Z LAST-MODIFIED:20210226T173451Z UID:10000077-1614868200-1614871800@theaahp.org SUMMARY:State of Research for Homeopathy DESCRIPTION:State of Research for Homeopathy\n AAHP invites you to hear from the world’s leading research expert Rachel Roberts\, BSc(Hons)\, MCH\, RSHom\, FSHom\, FFHom(Hon)\, Chief Executive at the Homeopathy Research Institute\, UK. \n Many in the homeopathy sector say there is “loads” of evidence homeopathy works. Detractors say there is no evidence at all that homeopathy is anything more than a placebo effect. As is often the way\, the reality is somewhere in between these extremes. In this presentation we will look at the true status of the clinical evidence base for homeopathy – including both its strengths and weaknesses – as well as identifying where some of the frequently repeated myths surrounding this topic originate\, so they can be firmly dispelled.\n MEET OUR GUEST SPEAKER \n \nRachel Roberts\, BSc(Hons)\, MCH\, RSHom\, FSHom\, FFHom(Hon)\, is Chief Executive of the Homeopathy Research Institute (HRI)\, a UK-based charity dedicated to promoting high quality research in homeopathy at an international level. HRI is committed to accurate communication of the evidence base in homeopathy and promoting new essential research projects of the highest quality.\n  \nRachel has a first class honours degree in Biological Sciences (Physiology) from the University of Birmingham. She graduated from the College of Homeopathy\, London in 1997 and was in private clinical practice until 2012. Rachel lectured in both homeopathy and medical sciences at various colleges in the UK and overseas before moving into the field of homeopathy research. She held the post of Research Consultant for the Society of Homeopaths from 2008-2012 and was awarded an Honorary Fellowship in 2013 to acknowledge her contribution to Homeopathy. Rachel joined HRI part-time in 2010 and has worked for the Institute full-time since 2012. In 2018 Rachel was awarded an Honorary Fellowship by the Faculty of Homeopathy in recognition of her work in the field of homeopathic research. \n WHEN \n \n2:30 – 3:30 pm ET \n PRICE \n \n \n Register Now\n \n After registering\, you will receive a confirmation email containing information about joining the webinar. Register early to secure one of the limited spots.\n \n\nHRI is an innovative international charity created to address the need for high quality scientific research in homeopathy. The charity was founded by physicist\, Dr Alexander Tournier\, who previously worked as an independent researcher for Cancer Research UK\, conducting interdisciplinary research at the boundaries between mathematics\, physics and biology. 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:20260418T074501 CREATED:20210108T202430Z LAST-MODIFIED:20210226T173430Z UID:10000076-1614861000-1614865500@theaahp.org SUMMARY:AAHP Annual Membership Meeting DESCRIPTION:AAHP Annual Membership Meeting\n \n PART ONE\n Meeting Opening and Association Projects \nMark Land\, AAHP President\nRegulatory Review\nAl Lorman\, Esq.\, AAHP Legal Counsel\nLegislative Climate\nPete Evich\, Van Scoyoc Associates and AAHP Lobbyist\n\nBoard Election Announcements and Voting Instructions \nResults to be announced by email following the conclusion of Part Two \n PART TWO\n \nRachel Roberts\, BSc(Hons)\, MCH\, RSHom\, FSHom\, FFHom(Hon)\, \n\n \n Learn More\n \n WHEN\n \n12:30-1:45 pm ET \n WHERE\n Annual Membership Meeting \nwill be hosted on Zoom \n \n Register for Part One\n \n \n Register for Part Two\n \n AAHP members must register for both the meeting and the guest lecture separately. Attendees will receive separate login credentials for each event. 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:20260418T074501 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:Poison Control in 2021\n A Complimentary Informational Webinar for Homeopathic Product Safety Stakeholders\n Join us to learn about Poison Control Center reports of exposure to homeopathic drug products\, and how you can work with the National Capital Poison Center (NCPC) to ensure that consumers receive accurate information and advice for unintentional and worrisome exposures to your company’s products. This one-hour webinar by the NCPC is complimentary to all homeopathic manufacturers (not limited to AAHP members). \n\n WHY DO POISON CONTROL STATISTICS MATTER TO YOUR COMPANY AND THE INDUSTRY?\n \n \n\n WHAT YOU WILL LEARN\n \n \nHow NCPC determines the potential toxicity of products and advises consumers.\nStatistics you can receive through a private exposure surveillance dashboard as an NCPC partner.\nHow your products appear to consumers on webPOISONCONTROL®.\nA brief overview the U.S. Poison Control System.\n\n\n WHEN\n \n February 9\, 2021\n1:00 – 2:00 p.m. EST\n\n PRICE\n \n \n \n Register Now\n \n After registering\, you will receive a confirmation email containing instructions about joining the webinar. Register early to secure one of the limited spots.\n\n ABOUT POISON CONTROL\n \n Each year\, millions of people reach out to the experts at poison control for help when they are exposed to common household substances\, including over-the-counter drugs. In keeping with the times\, NCPC – a 501(c)(3) charitable organization – developed online guidance for those who prefer not to call or can’t call. webPOISONCONTROL provides instant free triage recommendations and automated follow up for acute\, unintentional exposures to a vast array of products. The new tool\, which is also in the form of an app\, is used by 24 of the 55 poison control centers across the country. URL:https://theaahp.org/event/poison-control-in-2021/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20200923T110000 DTEND;TZID=America/New_York:20200923T170000 DTSTAMP:20260418T074501 CREATED:20200720T191019Z LAST-MODIFIED:20210216T142306Z UID:10000046-1600858800-1600880400@theaahp.org SUMMARY:AAHP Virtual Summit: Developing HPUS Guidelines for FDA Compliance DESCRIPTION:Join the alliance of homeopathic manufacturers\, pharmacists\, and other qualified parties in the homeopathic community for this powerful one-day investment featuring in-depth presentations by experts specifically in the homeopathic industry. \n  \nAAHP will assemble the highest quality information on key topics in a format that is responsive to attendees needs and regulators expectations. Discussions will affect the future\, providing retailers\, practitioners and consumers better\, safer\, reliable products for their wellbeing. URL:https://theaahp.org/event/virtualsummit2020/ CATEGORIES:Conference Event END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20200723T140000 DTEND;TZID=America/New_York:20200723T150000 DTSTAMP:20260418T074501 CREATED:20200707T144243Z LAST-MODIFIED:20210108T155835Z UID:10000045-1595512800-1595516400@theaahp.org SUMMARY:Homeopathic Shopper Panel in the Era of COVID-19 DESCRIPTION:In order to help manufacturers and marketers adapt during the era of COVID-19\, AAHP is offering a glimpse into the minds of core homeopathic shoppers-nearly in real time. During this engaging virtual event\, we’ll dive into survey data (collected in early July 2020) from the natural moms who purchase our products most. Featuring panelists from these mom groups\, our conversation will cover market drivers and the impact of COVID-19 on future shopping behaviors. \nWHEN\nThursday\, July 232-3 p.m. EDT | 11 a.m. – 12 p.m. PT \nPRICE\nREGISTRATION\n\nHow has the COVID-19 quarantine altered shopping behaviors for homeopathic medicines-and which behaviors will persist?\nAs mainstream retailers offer more homeopathic medicines\, how are natural consumers shifting from natural to mainstream stores?\nWhy are consumers buying and what is the perceived value of homeopathic medicines?\nWhere are the future opportunities to sell more homeopathic medicines to more people.\nMarketing and sales staff and C-levels at homeopathic companies\nRetailers interested in the shopping habits of the natural consumer\n\nMeet Our Expert Panelists\nLisa Lennon is the Social Media and Marketing Manager at Holistic Moms Network. This non-profit organization connects parents and creates supportive communities\, both in person\, through local chapters\, and online to help parents and others to learn about holistic and green living. \nJoette Calabrese\, HMC\, CCH\, RSHome(Na) is a well-known practicing homeopath with a large following through years of her blogs\, podcast series\, and weekly Facebook Live events. Visit www.PracticalHomeopathy.com. \nDr. Lauri Grossman DC CCH RSHom(NA) is President of the National Center for Homeopathy\, the largest consumer supported homeopathic organization in the US. She has been in private practice for more than 30 years and has taught workshops for consumers around the globe as well as for physicians in several NYC-area hospitals. \n  \nAndrea Fallin\, EVP\, Strategy at Racher Press\, oversees the strategic and creative initiatives for Chain Drug Review and MMR: Mass Market Retailer\, including new events\, digital programs\, and advertising campaigns. \n Register Now URL:https://theaahp.org/event/shopper-panel/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20200618 DTEND;VALUE=DATE:20200619 DTSTAMP:20260418T074501 CREATED:20200601T132613Z LAST-MODIFIED:20200601T132741Z UID:10000064-1592438400-1592524799@theaahp.org SUMMARY:2019–2020 HPUS Updates DESCRIPTION:2019–2020 HPUS Updates: Essential Information Companies Need to Know\n \n WHEN\n Thursday\, June 18\n1 PM EDT\n(12 pm CT\, 11 am MT\, 10 am PT)\n REGISTRATION\n Zoom WebinarRegister Now. \n WHO\n Presented by Eric Foxman\, RPh \n FDA’s revised Draft Guidance makes the Homeopathic Pharmacopeia a central focus of the Agency’s definition of what is and what is not homeopathic. Thus\, it is more important then ever for your company to be in-the-know regarding changes and updates in the HPUS. \n This webinar will review additions and changes to monographs in the HPUS\, including updates to quality control tests\, revised attenuation levels\, and modifications based on input originating outside the Convention. You will hear about new explanatory text regarding the Convention’s distinctions concerning marker compounds in relation to therapeutic activity. \nThe webinar will also provide you with information about an HPCUS project that is a priority in the coming months. This project will lead to documents focused on five cGMP related issues of particular importance for homeopathic drug products. \nAll manufacturers and marketers of homeopathic drug products need to be aware of this wide range of information to ensure your products and labeling do not fall into the FDA’s high-risk categories for enforcement action. \nAttend this one-hour AAHP Compliance Thru Education webinar for an overview of these changes; attendees can receive (post-webinar) four documents listing the monographs affected by these updates. \nWhether you manufacture or just market homeopathic drug products\, the new information in the HPUS has a bearing on your products’ compliance status. Regulatory and FDA review of homeopathic products over the past year support the critical importance of being current with the updates in the HPUS. These changes and updates may affect your business\, your cGMP compliance\, your products\, and your long-term success in the market! \n \n WHO SHOULD ATTEND\n \n Compliance ManagersQuality Control and Quality Assurance MangersStaff Responsible for Product FormulationsStaff Responsible for Product and Label ReviewMarketing StaffCEO’s and Senior Management \n \n COST\n \n $79**AAHP members will receive a $79 rebate for each registration after the webinar has ended. \n \n PRESENTER\n \n For four decades\, Eric Foxman RPh has been involved with the HPCUS in many capacities\, including its Board\, and as chair of the Council on Pharmacy. In this latter role\, Eric has helped with the review and revision of compendial documents to keep them current with contemporary cGMP expectations.Many in the industry know Eric Foxman as a member or company representative of the American Association of Homeopathic Pharmacists since 1979. He is in the 10th year of his third term on the Board of Directors. Eric has been a presenter or host of numerous AAHP Compliance Thru Education webinars addressing legal\, regulatory\, and technical aspects of the manufacture and marketing of homeopathic drug products; this is his eighth annual webinar on HPUS Updates. \n \n WEBINAR REGISTRATION\n \n Please click here to register for this webinar. You will receive an email confirmation shortly after you complete the registration.* Each webinar registration is for one computer/phone connection.* If it is physically possible at your location\, more than one participant may view the live webinar with no additional registration fee.* The registration fee has been purposefully kept low to make it possible for multiple employees of a company to attend at separate locations. AAHP members will receive a rebate for each registration after the webinar has ended.* Each registration will automatically receive one (1) Certificate of participation issued in the name of the registered participant. If you would like additional certificates of participation\, please send an email to info@aahp.info to indicate how many additional certificates you wish to purchase at $39 each; you will be contacted after the event for the names to be printed on the additional certificates and to arrange for payment through PayPal. For more information regarding the webinar\, contact Eric Foxman by phone (1-503-659-2715) or by email: info@aahp.info. URL:https://theaahp.org/event/hpus-updates/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20200306 DTEND;VALUE=DATE:20200307 DTSTAMP:20260418T074501 CREATED:20200113T205857Z LAST-MODIFIED:20200113T210207Z UID:10000073-1583452800-1583539199@theaahp.org SUMMARY:2020 Membership Meeting DESCRIPTION:AAHP ANNUAL MEMBERSHIP MEETING\n \n \n WHEN\n Friday\, March 6\, 20208 – 11 AM \n \n WHERE\n The Carion Hotel616 Convention WayAnaheim\, CA 92802 \n \n \n The 2020 AAHP Annual Membership Meeting is coming: Friday morning\, March 6\, 2020 at 8:00 am.  It will take place in the Clarion Hotel\, at 616 Convention Way\, Anaheim\, CA.\, a short walk from Natural Products ExpoWest; A light breakfast buffet will be available at 7:30 am; the meeting will conclude by 11:00 am to allow attendees to visit the show floor. \nAll members are encouraged to attend; there will be updates on the FDA Draft Guidance document (the comment period will end just weeks after the annual meeting) as well as the AAHP’s perspective on what issues may be a particular focus for the Agency moving forward. \nBoard Elections will also take place during the meeting.  All Voting Members in good standing will be eligible to vote. There are four positions on the Board up for election.  If you wish to nominate anyone (including yourself)\, you may do so until the end of January by contacting the AAHP office at info@aahp.info\, or calling the direct phone number: 503-659-2715. \nMark your calendar. More information and details regarding the meeting will follow. \nMembers unable to attend in person can participate by video/audio dial in.  Details will send distributed the week of the Annual Meeting. URL:https://theaahp.org/event/2020-membership-meeting/ LOCATION:Clarion Hotel\, 616 Convention Way\, Anaheim\, CA\, 92802\, United States END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20190627 DTEND;VALUE=DATE:20190629 DTSTAMP:20260418T074501 CREATED:20181212T190309Z LAST-MODIFIED:20190624T152259Z UID:10000070-1561593600-1561766399@theaahp.org SUMMARY:AAHP Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products: Keeping Your Business Compliant under FDA’s New Proposed Guidance DESCRIPTION:About the Summit\nNow more than ever\, it is vital to your business to be up to date on compliance issues in every area. To assist the manufacturers and labelers of homeopathic products\, the American Association of Homeopathic Pharmacists (AAHP) is offering regulators\, quality experts\, suppliers and those with allied interests a highly specialized one-day training. The small setting promises interaction with experts and peers to address your business concerns for a fraction of the cost of multiple consultants. \nFDA is expected to adopt its guidance of risk-based enforcement. Do your products fall into the regulatory priority categories the agency identified: products with reported safety concerns; ingredients associated with safety concerns; non-oral and non-topical administration; marketed for infants\, children\, the elderly\, etc.; or product not adhering to standards such as the Homoeopathic Pharmacopoeia of the United States. \nDon’t miss this powerful one-day investment — especially if your company will be present in the exhibit hall for the Joint American Homeopathic Conference. \n Who Should Attend\nRecommended attendees are staff with homeopathic manufacturers or businesses and consultants for this pharmaceutical industry related to manufacturing and labeling compliance. Company leaders\, such as the President and CEO\, are also welcome. \nQuality Staff \nEvent sponsor \n\nQuality Assurance\nQuality Control\n\nSafety Staff \n\nPharmacovigilance\nMedical\nToxicologists\n\nRegulatory Staff \n\nLegal\nMarketing\n\n\n What You Will Learn\n\nHow hot-button policy issues may impact your company’s bottom line\nHow best to prepare for FDA’s new enforcement priorities\nSave time and money developing a compliance strategy at small group workshop with access to in-depth experts to ensure business operations\nGain insight into important compliance procedures\nNetwork with the largest gathering of the American homeopathy community at the 14th annual Joint American Homeopathic Conference’s Reception.\n Knowledge Leaders\nAAHP Summit attendees will gain valuable insight on quality\, safety and regulatory issues in workshops developed under the guidance three experts. The limited-seating workshops also provide easy access to these notable professions for specific questions during this time of change for the industry. \nQuality Track Leader\n \nGeorge Bernstein\, PhD\nPresident\, MAI Consulting\nwww.ConsultMAI.com\n\nDr. Bernstein’s expertise ranges from GMP compliance\, facility design\, construction\, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP\, GCP\, GPP) for a major international pharmaceutical company\, and has assisted many clients with audit preparation\, remediation activities\, and communications with FDA. And for 30 years\, his family (including pets) have used homeopathic medicines. \nRegulatory Track Leader\nAnn M. Begley\nPartner\, Morgan\, Lewis & Bockius LLP\nwww.MorganLewis.com\nBased in Washington DC\, Ann Begley advises clients on FDA and FTC legal and regulatory issues relating to drug\, cosmetic\, dietary supplement\, food\, and medical device products — specializing in OTC drugs and clinical research matters. She provides guidance on product approval pathways\, formulation\, labeling\, product advertising\, compliance and strategic issues. Ann has represented many clients in connection with FDA and FTC enforcement actions/inquiries\, as well as competitor challenges before the Better Business Bureau’s National Advertising Division. \n Inaugural Industry Reception – Thursday\, June 27th\nWhere: Hilton Baltimore Carroll Room overlooking Camden Yards \nAAHP’s special evening reception celebrates its inaugural Summit. Join us for remarks from thought leaders and networking with senior executives from the homeopathic industry and other special guests. Hors d’oeuvres and cocktails will be served. Business attire is encouraged. \nSpeakers\nScott Emerson\nFounder & CEO\, The Emerson Group\nMr. Emerson’s forward-thinking consumer products equity organization manages CPG brands in excess of $4 billion\, and holds equity positions with small and medium-size brands. It provides international partners with the expertise and infrastructure to successfully penetrate the U.S. market. Mr. Emerson has more than 30 years’ experience\, including with Johnson & Johnson\, Unilever and Novartis Consumer Health. He has held senior management positions in Fortune 500 companies within brand management\, new business development\, sales operations and field sales. \n  \nWorkshop Speakers – Friday\, June 28th\n\nReview the three tracks below\, followed by a detailed schedule. \nOpening Keynote\nPresented by:\nFrancis Godwin\, MBA\nDirector\, Office of Manufacturing Quality\, Office of Compliance\, Center for Drug Evaluation and Research\, U.S. Food and Drug Administration\nAfter receiving his undergraduate degree from MIT in Chemical Engineering in 2001\, Godwin worked as a process engineer designing\, building\, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later\, he managed an analytical chemistry laboratory conducting analyses for production\, QA\, and research testing. In 2009 he received an MBA from Georgetown University and since then\, has been working at FDA in CDER’s Office of Compliance. He has served in various functions within compliance\, and is currently the Director of the Office of Manufacturing Quality\, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases. \nTrack 1: Quality \nEstablishing Analytical Specifications \nThis workshop will propose a development methodology to identify and quantify (if possible) quality and toxicological markers in the tincture and then in the dilutions and the finished products with examples of a gel and a syrup. \nPresented by:\nStephanie Chanut\nAnalytical Methods Development Laboratory Manager\, Boiron France\nSee Workshop Summary \nProcess Validation \n \nThis workshop will highlight the key differences between the FDA’s 2011 Guidance for Industry: Process Validation: General Principles and Practices and what was previously practiced. After a survey of the requirements\, many of the unique challenges and considerations for homeopathic manufacturers will be discussed\, including what you must know before you begin to develop a successful process validation program. \n  \nCo-presented by:\nEric Baier\nSenior Vice President Quality\, Hyland’s  and \n\nJohn Schottig\nDirector of Process Validation\, Hyland’s\nSee Workshop Summary \nFinished Product Testing / Content Uniformity \n \nAs FDA prepares to adopt its draft guidance\, this workshop will show how the industry could use a multi-country approach to strike a balance between the analytical cost and quality assurance. \nPresented by:\nFanny Guillot\nAnalytical Method Development\, Boiron France\nSee Workshop Summary \n\nTrack 2: Safety  \nPharmacovigilance \nThis presentation reviews best practice post market surveillance at a corporate level\, and how implementation can aid in the detection\, management\, and mitigation of the most serious product safety threats a company may face. \nPresented by:\nRichard Kingston\, PharmD\n President\, Regulatory and Scientific Affairs\, SafetyCall International\, PLLC\nSee Workshop Summary \n  \nIndustrial and Regulatory Toxicology \nPart I: Principles of Toxicology \nThe scientific community\, industry\, and regulators apply toxicology concepts to safety assessments of new products for human use and to industrial and environmental chemicals and mixtures that are/may become a part of our work force or daily environments. The FDA\, EPA\, and the international community have set precedents for methods of determining safe human exposure and dose levels. \nPart 1: See Workshop Summary \nPart II: Application of General Toxicology Studies to Support Regulatory Requirements \nBuilding upon the previous Safety Workshop\, Dr. Reed will detail how toxicology is utilized to determine safe starting doses for human use comparing and contrasting pharmaceutical and homeopathic approaches \nPresented by:\nMatthew D Reed\, PhD\, DABT\, Fellow ATS\nPrincipal\, Coelus LLC\nPart 2: See Workshop Summary \n\nTrack 3: Regulatory \nHomeopathic Product Substantiation—Concept to Shelf \n \nLearn how to develop a substantiation file; what types of claims can you make; and how to navigate the regulatory environment while still providing true homeopathic products. \nPresented by:\nSusan J. Hewlings\, PhD\, RD\nDirector\, Scientific Affairs\, Nutrasource\nProfessor\, Central Michigan University\nSee Workshop Summary \nTopics in Labels and Labeling \nHow will FDA’s new guidance affect homeopathic product labeling? Examples will be reviewed to help companies avoid areas of concern\, as well as reviewing crucial regulatory labeling requirements. \nPresented by:\nEric L. Foxman\, RPh\nRegulatory Consultant\nSecretary\, AAHP\nSenior Scientist\, HPCUS\nSee Workshop Summary \nEnforcement Hot Topics \n \nPrepare for your next FDA inspection. Hear trends detected through an analysis of domestic and international FDA reports. Learn to navigate FDA’s inspection database and dashboard for hot topics. \nPresented by:\nMark Land\, MS\, RAC\nVP\, Government & Regulatory Affairs\, Boiron USA\nPresident\, AAHP\nSee Workshop Summary \n  \n Registration\nRegistration is separate for the Summit and the Reception. \nClick Here to Register for the Reception! \nClick Here to Register for the Summit! \nOpening Reception\, June 27th \n\n\n\n\nTeam Rates \n\n\n\nEarly Registration \n\n\n\nFull Registration \n\n\n\n\n\n\nMember\nNon Member\n\nMember\nNon Member\n\n\n1st Attendee\n\n$250\n$395\n\n$295\n$500\n\n\n2nd Attendee\n\n$200\n$295\n\n$250\n$395\n\n\n3rd Attendee\n\n$175\n$250\n\n$200\n$295\n\n\n\n  \nAAHP Summit\, June 28th\n\n\n\n\nTeam Rates \n\n\n\nEarly Registration \n\n\n\nFull Registration \n\n\n\n\n\n\nMember\nNon Member\n\nMember\nNon Member\n\n\n1st Attendee\n\n$1000\n$1\,300\n\n$1\,200\n$1\,500\n\n\n2nd Attendee\n\n$900\n$1\,100\n\n$1\,000\n$1\,300\n\n\n3rd Attendee\n\n$800\n$1\,000\n\n$900\n$1\,100\n\n\nAcademic Rate\n\n$595\n\n\nGovernment Rate\n\n$695\n\n\n\n Schedule\nThursday\, June 27\, 2019 \n5:00–7:00 p.m.                Opening Reception in the Hilton Baltimore Carroll Room\, overlooking Camden Yards \n  \nFriday\, June 28\, 2019 \n  \n\n\n\n8:00–9:00 a.m.\nRegistration Open\n\n\n\n\n9:00–10:00 a.m.\n\n\nOpening Session: Scott Melville\, Consumer Health Products Association \n\n\n\n\n\n10:00-10:15 a.m. \n\n\n\n\nMorning Break with JAHC Attendees \n\n\n\n\n\n\n\nQuality Track \n\n\n\n\nSafety Track \n\n\n\n\nRegulatory Track \n\n\n\n\n10:15–11:45 a.m.\nEstablishing Analytical Specification\nby Stephanie Chanut\nBoiron France\nPharmacovigilance\nby Richard Kingston\, PharmD\nSafetyCall International\, PLLC\nClaims Substantiation\nby Susan J. Hewlings PhD\, RD\nNutrasource\n\n\n\n\n11:45–1:00 p.m. \n\n\n\n\nNetworking Lunch \n\n\n\n\n1:00–2:30 p.m.\nProcess Validation\nby Eric Baier & Karl John Schottig\nHyland’s\, Inc.\, a division of Standard Homeopathic Co.\nMethods in Toxicology\nby Matthew D. Reed\, PhD\, DABT\, Fellow ATS\nCoelus\, LLC\nTopics in Labels and Labeling\nby Eric L. Foxman\, RPh\nAAHP\n\n\n\n\n2:30–3:00 p.m. \n\n\n\n\nAfternoon Break with JAHC Attendees \n\n\n\n\n3:00–4:30 p.m.\nFinished Product Testing/Content Uniformity\nby Fanny Guillot\nBoiron France\nPopulations and Routes of Administration\nEnforcement Hot Topics\nby Mark Land\, MS\, RAC\nAAHP\n\n\n\n\n4:30–5:00 p.m. \n\n\n\n\nClosing Session \n\n\n\n\n5:00–6:30 p.m.\nJoint American Homeopathic Conference Opening Reception (cash bar)\n\n\n\n\n Booking Information\nClick here to make reservations. Use the dedicated link for the discounted conference rate through the Joint American Homeopathic Conference website: https://book.passkey.com/gt/216938400?gtid=1f7bc1cc225e8985a71c7801d8278673 \nAlternatively\, call the hotel directly at 866-238-4218 and reference the Joint American Homeopathic Conference discounted rate. \nThe group block could sell out prior to the discount cut-off date of Tuesday\, June 4\, 2019. Booking your reservation early is strongly encouraged. \nAbout Baltimore and the Hotel\nFor information on the hotel and surrounding area\, please visit the website for the Joint American Homeopathic Conference. \nhttps://www.jahc2019.org/hotel-information.html \nThe Hilton Baltimore and its prime Inner Harbor location offer many options for breakfast and dinner on your own. Within the hotel there is the Coffee Bean & Tea Leaf café\, the Diamond Tavern restaurant\, and the lobby bar. \n Sponsors\nPresenting Sponsor\nThe Emerson Group\nwww.EmersonGroup.com\nThe Emerson Group is a consumer products equity organization focused on accelerating mid-market brand growth. It also operates internationally\, providing partners in the European\, South American and Asian Pacific regions with the expertise and infrastructure necessary to successfully operate in the U.S. market. An Emerson Group division\, Emerson Logistics is a consumer products logistics solutions provider. A third division\, Emerson Marketing\, is an analytics and insights-based consumer products communications organization. \nPlatinum Level Sponsors\nBoiron\nwww.BoironUSA.com\nIn 1932 in Lyon\, France\, twin brothers and pharmacists Jean and Henri Boiron set out to develop a way to prepare reliable homeopathic medicines for their patients. Today Boiron continues as an independent pharmaceutical laboratory that prides itself on quality manufacturing and responsible environmental practices. We are passionate about integrating the benefits of homeopathic medicine into daily life. \n  \nHyland’s Inc.\nwww.Hylands.com\nFounded in 1903 and dedicated to supporting the health and wellness of families\, Hyland’s is a leading homeopathic company in North America and a top natural OTC brand. Hyland’s products have been shared by families for generations. Hyland’s medicines are prepared with the highest quality active ingredients and follow strict standards of preparation. \n  \nMAI Consulting\, Inc.\nwww.ConsultMAI.com\nMAI Consulting Inc. in Chapel Hill\, N.C.\, helps homeopathic manufacturers prevent inspection problems before they arise and address existing compliance issues. As a pharmaceutical consultant\, Dr. George Bernstein\, PhD\, works to improve the efficiency\, compliance\, and quality of small\, medium\, and large domestic and global allopathic and homeopathic companies. \n  \nMatrixx Initiatives\, Inc.\nwww.Zicam.com\nMatrixx Initiatives has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products for over 20 years. Matrixx Initiatives manufactures and markets Zicam® brand homeopathic OTC products\, including its clinically proven homeopathic ZICAM Cold Remedy Nasal Spray and Swabs and Cold Remedy RapidMelts®. \n  \nNelsons\nwww.Nelsons.net\nCompany Description: Nelsons is the UK’s leading manufacturer of natural healthcare products\, with a long-standing commitment to supplying the highest quality natural healthcare products that meet all regulatory and quality standards. Since 1995\, Nelson Bach USA Ltd has been the sole North American distributor of RESCUE REMEDY®\, BACH® Original Flower Remedies and SPATONE®. \n  \nSimilasan Corp.\nwww.SimilasanUSA.com\nSimilasan is dedicated to helping families feel good about feeling better. Our natural remedies provide temporary symptomatic relief from ailments of the eyes\, ears\, nose\, head\, and chest. Originating in Switzerland in 1980\, the Similasan brand became popular across Europe. Today\, Similasan remedies are widely used and well-respected in North America. \nEvent Supporters\nEric L. Foxman Consulting\nhttps://sites.google.com/site/ericlfoxman/home\nUsing in-depth expertise from decades of positions within HPCUS and AAAP\, Eric Foxman\, RPh\, offers private consultations to find solutions to our industry’s special compliance challenges. Eric helps companies comply in the areas of labeling design/text\, with the HPUS\, and cGMP through reviews of literature\, protocols\, and manufacturing technologies. He is also available to serve as a spokesperson in these areas. \n  \nCoelus LLC\nwww.CoelusBio.com\nOur staff conceptualizes and facilitates early to late phase development of pharmaceutical intellectual property and provides consulting services in integrated drug development strategies\, toxicology\, and pharmacology. We specialize in applying our expertise to pharmaceutics\, due diligence\, pharmaceutical-related government grants and contracts\, inhaled drug development\, inhalation and general toxicology\, and human health hazard assessment. \n  \nCPG Linkages\, LLC\nwww.CPGlinkages.com\nConnecting senior-level association\, manufacturer and retailer executives through targeted 1:1 meetings\, annual industry overviews\, conferences and other opportunities to drive mutual business growth. URL:https://theaahp.org/event/quality-safety-in-homeopathic-%e2%80%8b-%e2%80%8bmanufacturing-summit-%e2%80%8bkeeping-your-business-compliant-under-%e2%80%8bfdas-new-proposed-guidance/ LOCATION:The Hilton Baltimore\, 401 W. Pratt Street\, Baltimore\, MD\, 21201 END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20190515T130000 DTEND;TZID=America/New_York:20190515T140000 DTSTAMP:20260418T074501 CREATED:20190402T225547Z LAST-MODIFIED:20190408T203512Z UID:10000072-1557925200-1557928800@theaahp.org SUMMARY:Live Webinar: 2018/2019 HPUS Updates DESCRIPTION:Compendial and Homeopathic Attenuation Changes \nAAHP Compliance Thru Education Webinar\, Wednesday\, May 15\, 2019 \nat 1:00 p.m. ET • 12:00 p.m. CT • 11:00 a.m. MT • 10:00 a.m. PT \nHPCUS has continued to determine appropriate first safe attenuations for additional monographs—especially in light of FDA releasing its draft guidance. In addition\, two elements of the draft guidance have added a new dimension to these evaluations and have led to labeling changes. \nThis webinar will review the rationale for changes in the listed first safe attenuations and present HPUS labeling wording for selected monographed substances. All manufacturers and marketers of homeopathic drug products need to be aware of these new guidelines to ensure their products and labeling do not fall into high-risk categories identified by FDA for enforcement action. \nAttend this one-hour webinar to gain an overview of these changes\, information on new quality-control test specifications\, and changes to the HPUS Guidelines for Manufacturing Homeopathic Medicines and the HPUS Homeopathic Good Manufacturing Practices Guidelines. The webinar will also provide a glimpse of projects and activities that will be a focus of the Convention in the coming months. \nWhether you manufacture or just market homeopathic drug products\, the new information in the HPUS has a bearing on your products’ compliance status. Regulatory and FDA review of homeopathic products during the past year support the critical importance of being current with the updates in the HPUS. These changes and updates may affect your business\, your cGMP compliance\, your products and your long-term success in the market! \n  \nWHO SHOULD ATTEND \nCompliance Managers \nQuality Control and Quality Assurance Mangers \nStaff Responsible for Product Formulations \nStaff Responsible for Product and Label Review \nMarketing Staff \nCEO’s and Senior Management \n  \nPRESENTER \nFor nearly four decades\, Eric Foxman R.Ph. has been involved with the HPCUS in many capacities\, including on its board and as chair of the Council on Pharmacy. In this latter role\, Eric has helped review and revise compendial documents to make them more current with contemporary cGMP expectations. For more than a quarter century\, Eric has been also active on the Monograph Review and Standards & Controls Committees. \nMany in the industry know Eric Foxman as a member or company representative of AAHP dating back to 1979. He is in the ninth year of his third term on the Board of Directors. He has worked on Continuing Education modules for pharmacists\, and position statements of the association. Eric has been a presenter or host of numerous AAHP Compliance Thru Education webinars addressing legal\, regulatory and technical aspects of the manufacturing and marketing of homeopathic drug products. This is his seventh annual webinar on updates to the HPUS. \n  \nCOST: $179. AAHP members save $90 with the discount code available from the AAHP office. \n  \nWEBINAR REGISTRATION \nRegistration will open shortly. \n  \n* Each Live Webinar registration is for one computer/phone connection.
 \n* If you will be having more than one participant view the live webinar\, please use the Single Participant Registration; only one name will be requested for the “registered” participant. As many people may view the webinar with that connection as you desire.
 \n* Each registration will automatically receive one (1) Certificate of participation issued in the name of the registered participant. If you would like additional certificates of participation\, a link will be provided on the confirmation page after you register to indicate how many additional certificates you wish to purchase at $39 each; you will be contacted after the event for the names to be printed on the additional certificates. \n* Each separate computer/phone connection requires its own registration. \nFor more information regarding the seminar\, contact Eric Foxman by calling 1-503-659-2715 or by emailing info@aahp.info. URL:https://theaahp.org/event/live-webinar-2018-2019-hpus-updates/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20190308T090000 DTEND;TZID=America/New_York:20190308T113000 DTSTAMP:20260418T074501 CREATED:20190206T144757Z LAST-MODIFIED:20200113T205915Z UID:10000071-1552035600-1552044600@theaahp.org SUMMARY:2019 Membership Meeting DESCRIPTION:Join us for AAHP’s 2019 Membership Meeting this March to learn about the latest regulatory issues affecting our industry and reconnect with peers and colleagues! \nThe meeting will take place on Friday\, March 8\, from 9:00 – 11:30 a.m. in the Clarion Hotel and Resort (616 Convention Way\, Anaheim\, CA 92802)\, just one block from the Anaheim Convention Center and Natural Products ExpoWest show. \nHomeopathic Product Substantiation—from Concept to Shelf \nSince releasing it’s enforcement policy statement on marketing claims for OTC homeopathic drugs in November 2016\, the Federal Trade Commission (FTC) has taken action against several products. The agency feels its guidance covers product labels as well as advertising. The agency also believes that marketing claims for homeopathic drugs should be supported by competent and reliable scientific evidence (clinical trials) or by an appropriate disclaimer that informs consumers about the support\, if any\, for the claim.  \nIn a meeting with AAHP leaders\, FTC staff said that it would probably focus initially on “aggressive claims” for which consumers would expect scientific support. The staff provided examples of “aggressive claims” and other factors FTC will consider in bringing enforcement actions. To help companies view their product claims in light of FTC’s actions and stated intentions and to reduce companies’ risk\, AAHP has a guest expert\, Susan Hawlings\, to speak about Homeopathic Product Substantiation at AAHP’s first educational summit this June 28 in Baltimore.\n \nJoin AAHP and Susan next week at AAHP’s annual meeting where she will give an overview of the subject matter she will address in June\, including:\n\nsubstantiation per FTC and FDA guidance;\ndeveloping a substantiation file from concept to shelf;\nwhat types of claims can be made;\nnavigating the regulatory environment while still providing products true to homeopathy.\n\nPresenter \nSusan J. Hewlings\, PhD\, RD\nDirector of Scientific Affairs\, Nutrasource\nProfessor\, Central Michigan University\nDr. Susan Hewlings received her PhD in nutrition\, her BS in nutrition\, and her MS in exercise physiology\, all from Florida State. She is a Registered Dietitian\, and a full-time professor at Central Michigan University. Dr. Hewlings is the Director of Scientific Affairs for Nutrasource\, a full service CRO serving the dietary supplement\, pharmaceutical\, cannabis and CBD industries. She is Co-Founder of Substantiation Sciences LLC where she provides science and nutrition consulting services and medical writing for the dietary supplement\, cannabis and medical industries. She has published many articles and book chapters on sports nutrition\, dietary supplements and CBD/Cannabis \n  \nIn addition to the main topic of discussion\, the AAHP will also hold its annual Board elections. \nThe meeting room will open at 8:45 a.m. with coffee and light refreshments. The meeting will begin at 9:00 a.m. and will conclude before 11:30 so you can get to the show floor. \nAll members are strongly encouraged to have at least one representative present in person. \nWhile in Anaheim\, take time to visit the Natural Products ExpoWest show floor to see the variety and depth of product offerings in one of the biggest market channels for homeopathic drug products. If you still have to make hotel reservations and have difficulty finding a room near the Convention Center\, consider arriving the evening before and staying at a hotel near the John Wayne/Anaheim Airpor URL:https://theaahp.org/event/2019-membership-meeting/ LOCATION:Clarian Hotel\, 616 Convention Way\, Anaheim\, CA\, 92802\, United States END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20190110T110000 DTEND;TZID=America/New_York:20190110T120000 DTSTAMP:20260418T074501 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:11:00 a.m. ET • 10:00 a.m. CT • 9:00 a.m. MT • 8:00 a.m. PT • 16.00 GMT • 17.00 CET \nSummary\nWhether your company is located in the U.S. or the E.U.\, you need to be aware of regulations on “the other” side of the ocean in today’s global market. This is especially true for homeopathic drugs\, the starting materials for many of which are available only from one continent or the other. \nHow do the regulations within the supplier’s country impact your ability to import those starting materials? What are the ramifications of the end marketer’s national requirements on the export of homeopathic starting materials? \nAttend this important and timely webinar to: \n\nReceive an overview of the regulatory frameworks for homeopathic drugs in the U.S. and E.U.;\nUnderstand the fundamental differences between the U.S. and E.U. regulatory requirements; and\nGain insights into what you need to know for importing and exporting homeopathic drugs between the U.S. and E.U.\n\nThis one-hour webinar will introduce your company to the myriad of aspects every company needs to consider in today’s international marketplace. Presented by two established experts in the field\, this webinar will provide companies with the framework to understand the differences and comparisons between the U.S. and E.U. regulatory requirements\, as well as the impact of “the other” on your company’s suppliers and markets. The webinar will also provide an awareness of the differences between the various national pharmacopeias and why an ignorance of “the other” can lead to your products being deemed as misbranded or adulterated. \nPresenters\nSteve Mann\, Director of External Global Regulatory Affairs & QPPV\, Nelsons\n\nSteve has worked with Nelsons for more than 15 years with 20 years experience in the field of global regulation for homoeopathic drugs\, cosmetics\, herbal and dietary supplements\, and medical devices. He has worked on and managed regulatory and compliance projects in North\, Central and South America\, Europe\, North and East Africa\, Asia\, and Australasia. \nSteve currently holds board positions with various industry trade bodies\, including the British Association of Homeopathic Manufacturers (BAHM)\, the European Coalition on Homeopathic and Anthroposophic Medicinal Products (ECHAMP)\, and the U.K. Health Food Manufacturers Association (HFMA). He is also a Member of the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) and sits on the Standards and Controls and Monograph Review Committees\, and the Council on Pharmacy. \nEric Foxman\, Consultant and Board Member\, HPCUS\nEric has a rich history of work in the homeopathic industry. He has been a member of the Homeopathic Pharmacopeia Convention of the United States since its founding in 1980 and is presently in his 12th year on the Board of Trustees. Eric serves as the Senior Scientist of the Convention and the Chair of the Council on Pharmacy. In these capacities\, Eric is very active in the on-going revision and updating of the contents of the HPUS. \nEric has been active a member or representative of the American Association of Homeopathic Pharmacists for over 38 years. He has presented numerous workshops on legal\, regulatory and technical aspects of the manufacturing and marketing of homeopathic drug products. He also presents updates to the HPUS through an annual webinar. Eric is a consultant to the homeopathic industry with a focus on helping companies achieve compliance with the myriad of regulatory requirements for companies’ high-quality\, well-formulated homeopathic drug products. \nWho Should Attend?\n\nAmerican companies purchasing homeopathic materials from Europe\nEuropean companies shipping homeopathic materials into the U.S.\nAmerican companies exporting or interested in exporting homeopathic products to Europe\nEuropean companies importing American homeopathic products\nCompliance managers\nPurchasing managers\nQuality managers\nThose responsible for import/export\n\nCost\nNonmembers: $239\nAAHP Members: $149 (With $90 discount available from the AAHP office) \n  \nRegister Today!\n \n Click Here to Register 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:20180914T090000 DTEND;TZID=America/New_York:20180914T110000 DTSTAMP:20260418T074501 CREATED:20180718T164605Z LAST-MODIFIED:20180815T142524Z UID:10000065-1536915600-1536922800@theaahp.org SUMMARY:Semiannual Membership Meeting DESCRIPTION:Join AAHP for our Semiannual Membership Meeting! Held in conjunction with Natural Products Expo East\, the meeting allows you to unite with colleagues and peers to discuss challenges and opportunities—especially crucial at this time for our industry. Members and interested nonmembers are welcome! \nDoors open at 8:30 a.m. for a continental breakfast. Allow time for the limited elevators to bring you up to the meeting room floor. \nKeynote Speaker:\nDr. Jermey Kees\, founder and director\, Center for Marketing and Consumer Insights\, Villanova University \nDr. Kees leads AAHP’s successful consumer research project last year to identify appropriate disclaimer language for homeopathic drug product labeling and advertising. But having an appropriate text is not enough. FTC also requires any disclaimer to have appropriate prominence. What is “appropriate prominence”? That will depend on whether the text is being used on labeling\, in advertising\, on webpages\, in broadcast media\, etc. Dr. Kees will discuss various factors that you must take into consideration for placement to be considered successful. \n  \nPlease RSVP to info@aahp.info by Friday\, Sept. 7 to ensure adequate seating for all guests. URL:https://theaahp.org/event/semi-annual-meeting/ LOCATION:Holiday Inn Baltimore-Inner Harbor\, 301 West Lombard Street\, Baltimore\, MD\, 21201\, United States END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20180516T130000 DTEND;TZID=America/New_York:20180516T140000 DTSTAMP:20260418T074501 CREATED:20180424T151916Z LAST-MODIFIED:20180424T151916Z UID:10000068-1526475600-1526479200@theaahp.org SUMMARY:Live Webinar: HPUS Updates 2017/2018 DESCRIPTION:A Webinar on Compendial Definitions and Homeopathic GMPs changes \nCLICK HERE TO REGISTER. \nWednesday\, May 16\, 2018\n1:00 pm ET • 12:00 pm CT • 11:00 am MT • 10:00 am PT \nThe HPCUS has clarified the definitions affecting the OTC / Rx and External Use Attenuations. Updates are also being made to attenuation levels for selected monographs. The HPCUS has updated the Compendium’s Good Manufacturing Practices Guidelines to incorporate information in recent FDA documents. These changes and updates can affect your business\, your cGMP compliance\, your products\, and your long-term success in the market! \n\n\nThis webinar will review the wording and rationale for changes in the definitions that accompany the HPUS attenuation tables. The Council on Pharmacy has reviewed and revised the definitions to provide clarity and eliminate confusion. The webinar will also cover the changes in the HPUS Good Manufacturing Practices Guidelines and the Guidelines for Manufacturing Homeopathic Medicines\, which have been made to bring them into harmony with a recent FDA guidance document on APIs. \nAttend this one hour webinar for an overview of how these definitions and guideline changes might affect your company and your products. In addition\, the webinar will touch on other changes and additions implanted throughout 2017. An important aspect is the background information on the research results of the HPCUS Toxicity and Safety Committee which reviews the HPUS OTC attenuation levels and makes recommendations for changes that are ebing implemented by the Convention. \nWhether you manufacture or just market homeopathic drug products\, the new information in the HPUS has a bearing on your products’ compliance status. Regulatory and FDA review of homeopathic products over the past year support the importance of reviewing your GMP protocols and complying with the new guidelines and attenuation levels of the HPUS. \n\nPresenter\nEric Foxman RPh looks back\, and is sometimes surprised to see that he has been involved with homeopathy for 40 years. About 2/3rds of his life. “It’s not a rags-to-riches story (no one gets too rich doing homeopathic medicines)\,” says Eric. “It was partly a narrative of dumb luck and being in the right place at the right time. But more so\, it’s a tale of finding the making of homeopathic drug products resonated ‘just right’ with what lived inside of me.” Eric has have held various positions\, ranging from pharmacy clerk/helper while in high school to homeopathic compounding pharmacy director\, and manufacturing quality control manager. He presently provides consulting services on regulatory\, labeling and GMP issues to manufacturers of homeopathic and complementary medicines. \nFor 38 years\, Eric has been involved with the HPCUS in many capacities\, including on its Board\, and as chair of the Council on Pharmacy. In this latter role\, Eric has helped with the review and revision of compendial documents to make them more current with contemporary cGMP expectations. For more than a quarter century\, Eric has been also active on the Monograph Review and Standards & Controls Committees and their on-going work. \nMany in the industry in the last 4 decades know Eric Foxman as a member or company representative of the American Association of Homeopathic Pharmacists. He is in the 8th year of his third term on the Board of Directors. He has worked on Continuing Education modules for pharmacists\, and position statements of the Association. Eric has been a presenter or host of numerous AAHP Compliance Thru Education webinars addressing legal\, regulatory and technical aspects of the manufacture and marketing of homeopathic drug products\, as well as a series of webinars on previous updates to the HPUS. \n\n\nCOST: Non Members: $199. AAHP members get a $90 discount code available from the AAHP office. URL:https://theaahp.org/event/live-webinar-hpus-updates-2017-2018/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20180309T090000 DTEND;TZID=America/New_York:20180309T113000 DTSTAMP:20260418T074501 CREATED:20180131T195604Z LAST-MODIFIED:20180131T195604Z UID:10000067-1520586000-1520595000@theaahp.org SUMMARY:Semiannual Membership Meeting: March 2018 DESCRIPTION:One of the most important AAHP meetings in the last 15+ years. \nThe 2018 AAHP Membership Meeting will take place on Friday\, March 9\, from 9:00 – 11:30 a.m. in the Clarion Hotel and Resort (616 Convention Way\, Anaheim\, CA 92802)\, just one block from the Anaheim Convention Center and Natural Products ExpoWest show. This will be one of the most important AAHP meetings in the last 15+ years. \nWith the Comment Period for FDA’s Announced Guidance (of December 18\, 2017) drawing to a close less than 10 days after the annual meeting\, the focus of the agenda will be the draft of AAHP’s comments to FDA as well as updates on other steps the association is taking on behalf of membership to address this announced guidance. \nAAHP legal counsel\, Al Lorman\, and legal and regulatory committee chair\, Jay Borneman will bring membership up to date on the input received from membership\, the various points considered in drafting AAHP’s comments\, and the draft itself as it stands at the time of the meeting. This is an important discussion\, and the AAHP urges all members to make every possible effort to be present in person in order to fully participate in the final shaping of the comments. \nAAHP lobbyist\, Pete Evich\, will also provide members with insights into the legislative efforts the AAHP has undertaken to complement the submission of our comments to FDA. This is also an important process with which all members should be familiar. \nIn addition to the main topic of discussion\, the AAHP will also hold it’s annual Board elections. \nThe meeting room will open at 8:45 a.m. with coffee and light refreshments. The meeting will begin at 9:00 a.m. and will conclude before 11:30 so you can get to the show floor. \nAgain\, all members are strongly encouraged to have at least one representative present in person. \nWhile in Anaheim\, take time to visit the Natural Products ExpoWest show floor to see the variety and depth of product offerings in one of the biggest market channels for homeopathic drug products. If you still have to make hotel reservations\, and have difficulty finding a room near the Convention Center\, consider arriving the evening before\, and staying at a hotel near the John Wayne/Anaheim Airport. URL:https://theaahp.org/event/semiannual-membership-meeting-march-2018/ LOCATION:Clarian Hotel\, 616 Convention Way\, Anaheim\, CA\, 92802\, United States CATEGORIES:Meeting END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20170518T130000 DTEND;TZID=America/New_York:20170518T140000 DTSTAMP:20260418T074501 CREATED:20170426T171219Z LAST-MODIFIED:20170511T180610Z UID:10000048-1495112400-1495116000@theaahp.org SUMMARY:2017 HPUS Updates: A Webinar on Homeopathic GMPs and Stability DESCRIPTION:The Homeopathic Pharmacopeia of the United States has posted two new documents to the HPUS. These documents and their guidance information are essential to your business\, your cGMP compliance\, your products and your long-term success in the market! \nAttend AAHP’s next Compliance Thru Education webinar on Thursday\, May 18\, 2017 at 1:00 p.m. ET • 12:00 p.m. CT • 11:00 a.m. MT • 10:00 a.m. PT to introduce and prepare you to make use of these documents. \nPRESENTER: Eric Foxman\, RPh\, a founding member of the Homeopathic Pharmacopeia Convention of the United States. \nCOST: Non-Members: $199. AAHP members get a $90 discount code available from the AAHP office. \nREGISTRATION: Please use the following link to register for this webinar. You will receive an email confirmation shortly after you complete the registration. \nhttp://eventcallregistration.com/reg/index.jsp?cid=69840t11 \nFor more information regarding the seminar\, call Eric Foxman (1-503-659-2715) or by email: info@theaahp.org \n  \nThe AAHP NetworkNews had a quick conversation with presenter Eric L. Foxman about what will be covered in the webinar. \nNetworkNews: In a nutshell\, what are you going to talk about? \nEric L. Foxman: The Homeopathic Pharmacopeia of the United States has posted two new documents to the HPUS. These documents and the guidance information in them are essential for every homeopathic company. Whether a company manufactures or just markets homeopathic drug products\, the new information in the HPUS has a bearing on every product’s compliance status. \n  \nNN: What are those two documents? \nELF: The first is a major revision of the HPUS Homeopathic Good Manufacturing Practices Guidelines. At first glance\, it is obviously much longer. But it’s more than just verbiage. A closer examination reveals the previous version touched on about 40 important considerations; the revision addresses more than 175 points that manufacturers and marketers need to be aware of. \n  \nNN: And the other document? \nELF: This is a brand new document for the HPUS\, entitled Homeopathic Drug Stability Guidelines. It addresses issues concerning stability testing and retest periods; these are subjects that directly impact every homeopathic product marketed in the U.S. \n  \nNN: What else will you address in the webinar? \nELF: There are a few new monographs that have been approved for publication\, and more than four-dozen additional monographs now have quality control specifications. I’ll touch on an update to the alcohol coefficients in the Guidelines for Manufacturing Homeopathic Medicines\, as well as the results of discussions the Convention has had regarding California’s Proposition 65 and its impact on OTC attenuations. And perhaps the most important subject will be the implementation timeline of the HPUS Expanded Labeling Guidelines. \n  \nNN: How long will the webinar be? \nELF: I am going to keep it to an hour to make it possible for the most people to participate within their busy schedules. Thus\, I will be providing an overview on all these subjects but am also working to prepare downloadable documents that provide more detail on the scope of the additions and changes. For instance\, there will be a downloadable document that provides an outline comparison between the subjects covered in the previous Homeopathic GMPS document and the newly revised version. My intention is to provide attendees with a solid introduction so they can best make use of these documents. The information in these documents is essential for every homeopathic business to ensure the products they bring to market meet reasonable and appropriate expectations for homeopathic drug products while assuring a consistent level of quality. \n  \nNN: This is the fourth webinar you have presented on the HPUS for the AAHP. How long have you been involved with the Homeopathic Pharmacopeia? \nELF: I am what one might call a charter member of the HPCUS. Looking back\, I realize that I have been involved with the Pharmacopeia Convention for 37 years – since its establishment in 1980. For many years\, I was the chair of the Pharmacopeia Revision Committee. I am now in my 10th year on the Board of Trustees of the HPCUS and for almost as long I have served as the Chair of the Council on Pharmacy. In these capacities\, I am active in the ongoing revision and updating of the contents of the HPUS. I also serve on the Monograph Review Committee\, and continue\, after more than a quarter century\, on the Standards and Controls Committee. I guess that’s why I feel comfortable sharing these updates with the homeopathic industry. URL:https://theaahp.org/event/2017-hpus-updates-a-webinar-on-homeopathic-gmps-and-stability/ CATEGORIES:Webinar END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20170310T090000 DTEND;TZID=America/Los_Angeles:20170310T110000 DTSTAMP:20260418T074501 CREATED:20170106T204838Z LAST-MODIFIED:20170206T153617Z UID:10000049-1489136400-1489143600@theaahp.org SUMMARY:Semiannual Membership Meeting: March 2017 DESCRIPTION:Join AAHP for our Semiannual Membership Meeting at 9:00 a.m. PST on Friday\, Mar. 10\, 2017 at the Clarion Hotel in Anaheim\, Calif. \nHeld in conjunction with Natural Products ExpoWest\, the association’s semiannual conference allows you to unite with colleagues and peers to discuss challenges and opportunities—especially at this crucial time for our industry. \nThe program will include updates on AAHP’s dialogue with the U.S. Federal Trade Commission regarding their announced Enforcement Policy\, insights into the association’s recent meetings with Congressional members and staffers\, as well as a conversation about pharmacovigilance. We will also highlight current AAHP projects and priorities. \nAdditionally\, we will elect four Board members\, and we are currently seeking nominations.* If you know someone you think would be excellent in leading the association\, please email info@theaahp.org. \nAll AAHP members may attend the conference free of charge. See you in Anaheim! \n*Nominees must be representatives of companies with two years of continuous membership prior to election\, and one of the elected Board members will be from a company with five years of continuous membership. At this election\, up to two nonvoting members may be elected. The same continuous membership requirements apply. URL:https://theaahp.org/event/semi-annual-membership-meeting-march-2017/ LOCATION:Clarian Hotel\, 616 Convention Way\, Anaheim\, CA\, 92802\, United States CATEGORIES:Meeting END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20150111 DTEND;VALUE=DATE:20180111 DTSTAMP:20260418T074501 CREATED:20140127T202949Z LAST-MODIFIED:20150123T183958Z UID:10000056-1420934400-1515628799@theaahp.org SUMMARY:Best Branding Practices Webinar Archive DESCRIPTION:How to make your product stand out in a crowd: selling products\, services and your company’s image. \n\nThe Homeopathic market place is estimated to have have reached $1 billion in sales in 2011 and is still growing!\nAnnual growth has been estimated at between 3 and 5%.\nBranding your company\, products and services to differentiate you from the crowd while accelerating your growth is now more important than ever.\n\nHomeopathic companies and products must work harder than ever before to stand out in today’s crowded marketplace of natural and OTC drug products. Reaching the consumer with your message\, image and benefits through the multitude of competing products and messages is tough to accomplish. Consumers are seeking solutions and at the same time are rushed and pressured and faced with a multitude of competing messages. Your brand’s image and message must be on target to capture their attention\, help them relate to your product and make them your customer. \nEvery Company\, every brand and every product competes for store placement\, shelf space\, advertizing space and retailer and consumer attention. Gone are the days of using trade show booths\, shelf talkers and magazine ads to reach retailers and consumers. Today’s market is one of diverse communication channels and all of these channels can lead to consumers\, sales and growth. Reaching out through established and new media channels still requires that the basics of good branding are accomplished with the added challenge of embracing greater consumer interaction through websites and new and interactive media. \nThis Webinar Covers\n\nThe latest information on what drives consumer trends and what consumers are saying about homeopathic products.\nDefining and differentiating your brand – what is branding\, how to define your brand and the art of standing out from the crowd.\nCreating clear\, consistent AND motivating brand messages across all customer touch points from consumer promotions to retail outlets to websites and media. Expert advice from a homeopathic marketer who expanded a brand’s sales and marketing reach while expanding the product line.\nThe emerging ‘New Media’ opportunities of the internet and social networking in brand and image building and management.\nHow to build a brand on any budget.\n\nWho Should View…\n\nOwners\, CEOs and management responsible for band and company mission\, image\, sales and growth\nMarketing managers and staff responsible for advertising\, media and message\nDesigners and marketers responsible for product image\, package design and labeling\nManufactures and service suppliers to the homeopathic industry for how to promote your services to the industry and maximize your company’s image and message\n\nMeet the Presenters\nBob McNabb\, Business Director for Natural Marketing Institute. NMI is an international strategic think tank\, specializing in health\, wellness\, and sustainability since 1990 with full-service market research resources. NMI’s annual\, syndicated consumer database allows them to keep their finger on the pulse of consumer trends. Bob addresses homeopathic medicines’ household penetration\, perceived effectiveness\, perceived safety\, and the usage (increased/ decreased/ stayed the same) of homeopathic medicines. \nCynthia Batterman is the Principal at Essex Consulting. Cynthia is a senior marketing executive and general manager with a strong track record of transforming and building businesses in both private and publicly traded companies. Previously as President of Nelsons she is credited with the development of a pipeline of new products\, winning 5 “best new product of the year” awards\, and generating record levels of sales and profits for Nelsons. With an additional 15+ years of experience in Fortune 500 companies as well\, so is skilled at developing “big company strategies” on “small company budgets.” Cynthia is a Board member on the AAHP\, is past Chair of the Education Committee\, and is currently Chair of the Publicity Committee. Cynthia speaks about brand positioning strategies … what Branding is\, how to create one\, and why it is important to a company’s long-term strategy and growth. \nTara Deville\, National Director of Media\, Brand Digital\, presents Digital Connection Marketing\, the art and science of crafting two-way interactions online that inject meaning\, interest and emotion into an audience’s experience of a brand. By continually pushing to better define audiences\, we help uncover the insights that inspire and shape communications and connections. Brand Digital clients include many well-known pharmaceutical companies such as Novartis\, Merck and Roche\, as well as Kellogg’s\, Sears\, St. Jude’s Hospital\, and Budweiser. \nDanielle Conte\, creative energizer\, insights wizard and super strategist at Vertical Marketing Network\, LLC will be speaking on how to translate your brand into consumer marketing campaigns which are full of market insights and bright and bold ideas … while driving sales and strong returns on investments. Danielle works to create new marketing approaches\, opportunities and innovation that lead the way to meeting and exceeding business and sales objectives. Vertical’s. Client list include ConAgra Foods\, Unilever\, Warner Bros.\, Abbot Medical Optics\, Mead\, Del Monte\, and GE Capital. \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount. \n[button color=”blue” url=”mailto:info@theaahp.org?subject= Best Branding Practices Webinar Archive Inquiry” size=”small”]Click here to order[/button] 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:20260418T074501 CREATED:20140127T203742Z LAST-MODIFIED:20150123T183039Z UID:10000054-1420848000-1515542399@theaahp.org SUMMARY:Managing Consumer Calls: Complaints\, cGMP Compliance\, Quality and Service Webinar Archive DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nCustomers are one of the most valuable assets of any company\, even though they do not typically show up on a company ledger sheet or on a list of company assets. Customers are why we are in business and meeting their needs and providing great service is important to our businesses. Customer calls are an important touch point for every company and need to be managed to insure customer satisfaction and safety. \nCustomer calls and complaints have been mentioned in a number of recent FDA warning letters as the Agency continues to stringently enforce cGMPs during inspections. Case in point\, Novartis Consumer Health Inc. is one of the more prominent reminders of the importance of investigating consumer complaints. \nIn 2010 Novartis was cited for inadequate investigation of consumer complaints\, some including adverse events related to an uncharacteristic odor. The complaints were received over a period of more than 2 years\, and numbered well over 100 in the first six months alone. Initial investigations failed to determine the cause of the odor and the investigation was dropped only to have the same complaints the following year. Again\, an investigation was undertaken with no clear cause or findings and again dropped by Novartis. \nThe FDA sited the lack of adequate quality review and investigation and the failure to reach a root cause for the complaints. The FDA detailed the need for improved SOPs\, improvement in QC management and training\, performing adequate investigations of consumer complaints and initiation of corrective actions in response to consumer calls along with an investment by Novartis of $150 million to upgrade manufacturing and quality at their manufacturing sites. \nIgnoring and not investigating consumer complaints can be a costly oversight. Your customers deserve to have their questions and complaints investigated and to receive clear reassurances that your systems are under control and your products meet their quality and safety expectations. \nManufacturers and private label marketers of drug products must be prepared with procedures to receive and manage consumer calls and complaints\, investigate complaints for their root cause\, and create and implement corrective actions to prevent recurrences. Companies need to have SOPs and personnel training in place\, along with a process for documenting each call\, each investigation\, any findings and all corrective actions. Determining when a customer call may be more than a complaint and is a potential adverse event is essential for consumer safety and compliance. \nPrivate label marketers must be prepared to work with their contract manufacturing partners to investigate consumer complaints and to determine the necessary corrective actions. Contract manufacturers are responsible for performing the necessary investigation to determining the possible cause of a consumer complaint and documenting the investigation and any corrective actions and retraining necessary. \nNote: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training. \nThis Webinar Covers:\n\nWhat the cGMP requirements are for marketers and manufacturers of drug products in managing consumer complaints;\nHow to conduct a thorough investigation of the complaint;\nImportance and tools for investigating consumer complaints;\nThe requirements and value of performing corrective actions.\n\nAbout Our Presenters\nAlvin J. Lorman\, Esq. is currently the attorney for the AAHP and has been for over 25 years representing the interests of homeopathic drug manufacturers and marketers with the FDA and legislators. He also served as associate general counsel of the CHPA. Al has over 30 years of practice with large national and international law firms and practices in all areas of food and drug law\, biotechnology and health law\, trade association law\, and advertising law. He lead the industry effort which resulted in the publication of FDA’s Compliance Policy Guide on homeopathy\, a policy which has lead to a dramatic increase in the availability of homeopathic products. Al introduces the issues surrounding the management of consumer calls and complaints and their importance to your business. His experience and insights are of special value given his experience and expertise working with the issues and our homeopathic industry. \nMary Beth Watkins\, MS\, BS\, is the Director of Quality and Compliance for Nutraceutical Corporation Homeopathic products\, with over 25 years in quality management experience in formulation\, manufacturing\, quality\, labeling and cGMP compliance of homeopathic drugs\, OTC drugs\, dietary supplements and herbal products. Mary Beth has experience in working with the FDA and Federal Code of Regulations for compliance\, inspections\, documentation\, laboratory and department management and quality testing. Mary Beth speakes about the details of ‘things gone wrong’ that could have been prevented with a proper system in place. \nWalt Murray of MasterControl is currently the Director of Quality & Compliance Consulting Services. He is a QMS Certified Lead Auditor and has over 30 years of experience in operational responsibilities for quality in manufacturing and regulatory oversight and provides assistance to clients and life science companies in need of guidance and development. Walt provides a in-depth look at systems for handling complaints from initial incoming contact thru investigation follow-thru. MasterControl provides software solutions that enable regulated companies to get their products to market faster\, while reducing Cost of Quality (COQ) and increasing internal efficiency. MasterControl provides secure management solutions for a company’s critical quality information throughout the entire product lifecycle. MasterControl solutions include quality event management (QEM)\, document management\, product lifecycle management (risk management)\, audit management\, training management\, document control\, bill of materials\, supplier management and much more. \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount. \n[button color=”blue” url=”info@theaahp.org?subject= Managing Consumer Calls Webinar Archive Inquiry” size=”small”]Click here to order[/button] 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:20260418T074501 CREATED:20140127T204309Z LAST-MODIFIED:20150123T183007Z UID:10000053-1420761600-1515455999@theaahp.org SUMMARY:From Leaf to Label - Quality Throughout the Cycle -- Webinar Archive DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nAnyone who makes a habit of reading FDA warning letters will have noticed the unmistakable trend in the increased FDA scrutiny of cGMPs throughout the product life cycle. This scrutiny runs from ingredients and components to finished products. This AAHP seminar will highlight key compliance steps from starting materials and components\, through manufacturing processes and the specifications\, evaluation and testing of finished products. \nVender qualification and the confirmation through testing of materials\, components and finished products are critical for manufacturers\, marketers and contract labelers alike. The FDA frequently cites companies for failure to qualify suppliers\, set specifications for materials and components and for not testing and evaluating materials and products to ensure they meet specifications. \nEnsuring quality means all the internal systems are in place to verify that quality is built into processes and products through the entire manufacturing cycle — from ’leaf to label’. Starting materials\, excipients\, and components must all have written specifications and be inspected\, sampled\, tested and evaluated to determine if they are suitable for use in the manufacture of homeopathic products \nThe FDA has steadily increased the number of Agency inspections and warning letters over recent years. In 2010 the trend peaked at 189 warning letters to drug firms or about one every 6 days. This was an increase of 320% over the number of 2008 warning letters. In 2012 the number of warning letters had declined to 73 still almost a 50% increase over 2008 levels. And it is not just the number of inspections\, but also the increased scrutiny of systems\, data and outcomes\, which have made a number of recent inspections particularly detailed and intense. This is the new reality of FDA oversight. \nWebinar Covers:\n\nvender qualification\, quality audits\nsupplier assessment and performance and quality agreements\nmanufacturing processes\, validation and packaging\nfinished product specifications; container\, closure\, label\, product\ntesting for release\n\nNote: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training. \nWho Should View?\n\nOwners\, CEOs and management responsible for corporate compliance with FDA requirements.\nQA/QC staff responsible for establishing specifications and testing of components.\nManufacturers\, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.\nMarketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality\, safety and labeling.\n\nOur Presenters:\nJaneen Skutnik\, a partner at NSF\, speaks about establishing specifications\, testing and conformance to specifications for materials\, components and especially finished products. Her guidance will be valuable to manufacturers and contract marketers in better understanding the breadth and depth of the testing and documentation which is needed for OTC drugs \nPejman Parhami\, Director of Quality Systems with Standard Homeopathic\, speaks to supplier management vender qualification\, quality audits\, supplier assessment and performance and quality agreements. This very informative section will be important to both manufacturers and private label marketers. \nSteve Mann\, Head of Global Regulatory Affairs & Quality Assurance at Nelsons Int. UK speaks about the challenges manufacturers and contract marketers face in meeting FDA expectations for manufacturing homeopathic drugs\, filling and finished product specifications. \nThis 2 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $149 (includes S&H); AAHP members get a $100 discount. \n[button color=”blue” url=”mailto:info@theaahp.org?subject=Leaf to Label Webinar Archive Inquiry” size=”small”]Click here to order[/button] 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:20260418T074501 CREATED:20140127T203405Z LAST-MODIFIED:20150123T182934Z UID:10000055-1420675200-1515369599@theaahp.org SUMMARY:Managing Contract Manufacturing Responsibilities and Relationships Webinar Archive DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nDon’t put your business at risk by not thoroughly understanding and implementing the responsibilities & duties of a contract manufacturing and marketing relationship! \nThe Food and Drug Administration Safety and Innovation Act (FDASIA) profoundly affects all contract manufacturers and contract marketers. With the many changes elucidated by FDA\, one thing is clear: the contract relationship puts both parties at considerable risk if either one fails to follow through on its obligations. \nManaging contract manufacturing relationships requires that both parties\, the contract manufacturer and the contract marketer\, meet their regulatory compliance obligations; communicate frequently\, effectively and honestly; comply with cGMPs; and work well together with mutual trust and respect. Contract manufacturing agreements can assist in managing responsibilities and liability for both parties. When one partner in the contract agreement fails to meet any of these requirements they place both companies\, their other customers\, and all end product consumers at risk. \nFDA inspects both contract manufacturers and contract marketers. Here are examples of the FDA’s comments in recent months to contract manufacturers and marketers: \n\nContract Marketer – your firm has not established any written specifications for your finished products for your contract manufacturer and has failed to test any received lots of products for conformance to specifications.\nContract Manufacturer – your firm does not have adequate procedures for production controls designed to assure that the drug products you manufacture have the identity\, strength\, quality and purity they report or are represented to possess.\nContract Marketer – your firm failed to conduct an investigation into numerous consumer complaints associated with broken or damaged tablets and bottles.\nContract Manufacturer – your firm relies solely on the supplier’s COA for quality assurance of components and raw materials and has failed to establish written specifications for these materials and components and has not performed specific identity testing for approval for use and has not established the reliability of the supplier’s analysis through appropriate validation of the suppliers test results.\nContract Marketer – your firm failed to establish product specifications for each of your contract manufactured products and failed to test each lot of finished product for conformance to specifications or manufacturer’s COA.\nContract Manufacturer – your firm failed to establish adequate procedures for the quarantine\, sampling\, inspection\, review\, accuracy and approval of labeling supplied by contract marketers for all contract product labeling.\n\nFDA is giving increasing attention to setting\, validating and meeting product specifications. And the Agency increasingly expects both partners in a manufacturing relation to be equally responsible for many aspects of quality. \nContract manufacturers and contract marketers represent a major segment of the homeopathic industry\, which is growing with new labels\, marketers and manufacturers added each year. The FDA treats these relationships seriously\, citing manufacturers for failure to meet GMPs\, failure to list contract manufactured products and the lack of stability data. On the other side of the relationship\, the FDA has cited contract marketers for failure to meet GMPs for their products due to contract manufacturer failures\, failure to audit contract partners and for labeling errors. \nNote: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training. \nMeet the Presenters\nThree industry leaders discuss the requirements and responsibilities of contract manufacturing relationships\, agreements and complying with FDA cGMPs. At least 5 take-away handouts provide sample audit forms and suggested quality contract language to get you started\, or to help clarify and improve your present agreements and implementation. \nCathy Raish\, Quality & Regulatory Manager for Heel Inc. Cathy has over 25 years experience working in the homeopathic OTC and prescription drug industry with responsibilities for quality and regulatory compliance. She works closely with purchasing\, suppliers\, manufacturing\, and distribution to help create a robust\, GMP compliant supply chain for products manufactured at Heel for both branded and contract manufacturing products. Cathy is a member of APICS\, The Association for Operations Management and ISPE\, the International Society for Pharmaceutical Engineering and was recently accepted as an associate member of HPUS where she serves on the Council of Pharmacy and Standards and Controls Committees. \nRobert Cohanim\, owner Historical Remedies is a multicultural resident who immigrated to the US from Europe and the Middle East in the mid 1970s. He has a BA from Macalester College in St. Paul\, MN\, and an MA in interdisciplinary studies from the University of Minnesota. His interest in homeopathy developed soon after graduating\, as a result of his exposure to the health care systems in France and other European countries. Robert founded Historical Remedies in the late 1980s in order to give a more accessible face to over-the-counter medicines\, and to inspire a positive approach to self-care through homeopathy. \nTravis Borchardt has spent 13 years at Enzymatic Therapy and Schwabe North America setting the standards of quality assurance\, quality control\, and regulatory compliance for products sold as dietary supplements\, OTC homeopathic drugs\, OTC monograph drugs\, cosmetics\, foods and a European Union (EU) prescription pharmaceutical. He has incorporated good laboratory practices\, and transparency with governmental agencies; helping earn the following titles: National Sanitation Foundation’s (NSF’s) Good Manufacturing Practices (GMP’s) Certification\, United States Department of Agriculture’s (USDA’s) National Organic Program Certification\, and Therapeutic Goods Administration (TGA) GMP Certification. As a current board member of the American Association of Homeopathic Pharmacists (AAHP) and the American Herbal Products Association (AHPA)\, Travis helps to shape industry business and quality standards for the homeopathic and dietary supplement industries.\n \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount. \n  \n[button color=”blue” url=”mailto:info@theaahp.org?subject= Contract Manufacturing Resp. & Relations Webinar Archive Inquiry” size=”small”]Click here to order[/button] 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:20260418T074501 CREATED:20150123T181933Z LAST-MODIFIED:20230321T192241Z UID:10000050-1420588800-1515369599@theaahp.org SUMMARY:The Homeopathic Market – Analytical Tools for Understanding and Growth Webinar Archive DESCRIPTION:Homeopathic consumers\, users and supporters are a breed apart. They are that special segment of the natural products / natural health consumer population that supports and uses complimentary medicines. All homeopathic manufacturers and marketers would be excited to learn more about these unique consumers\, their interests\, motivations and purchasing habits. \nNow there is an opportunity to do just that! \nIRI is a leader in delivering comprehensive market and shopper information based on their own data collections augmented by other sources\, such as SPINS\, etc. And they provide the predictive analytics to help companies utilize the data in helpful and meaningful ways. IRI showcases the tools available to help understand and thrive in the homeopathic market with the growing segment of homeopathic consumers. IRI will draw on their extensive experience with: \nConsumer understanding – consumer analytics\, marketplace insights\, survey solutions \nGrowth and new product innovation – foresight\, launch forecasting\, product profiles \nMarketing performance and management – market testing\, price& trade advantages\, analytics \nSales and channel management – shopper behavior\, new products\, packaging\, pricing and promotion \nShopper –Centric Collaboration – insights\, analytics\, solutions loyalty \nThis presentation is tailored especially for the homeopathic market on IRI’s data collection and analytical tools. Be prepared to gain insights into how you can find out more about your customers and potential customers. Plus a fresh view of the analytics at hand to help your company make the most of the information available. This 45 minute webinar will provide you with a concise overview of IRI and the importance of well-executed analysis on our homeopathic market. \nWho should view this archive? \n\nOwners\, CEOs and management responsible for overall market and sales growth.\nMarketing managers and staff responsible for marketing campaigns and new product launches.\nManufacturers\, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.\nMarketers of private label brands responsible for the marketing their homeopathic products.\n\nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $179 (includes S&H); AAHP members get a $90 discount. \nLimited Time Special Package Pricing: order this DVD plus the Consumer Trends and Insights Webinar Archive at the same time and get both for $269 (includes S&H). That’s a savings of $90 over ordering them separately.  AAHP Members save even more: order both at the same time and get a $130 discount. 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:20260418T074501 CREATED:20140127T200856Z LAST-MODIFIED:20150123T182821Z UID:10000057-1420502400-1515196799@theaahp.org SUMMARY:How To Survive a Product Recall Webinar Archive DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nIt may not be possible to be fully prepared to conduct a product recall but with good preparation you and your company will survive and your reputation and your relationship with your customers will remain intact. \nWhat the FDA Expects…… \nWhen an adverse event\, product quality failure\, or manufacturing mistake occurs that places consumers at risk\, your company may be faced with a possible product recall. It is important to know your company’s responsibilities as well as your rights. You need to determine the reason for the recall\, and the level of hazard to consumers. FDA will expect your company to be prepared to recall a product effectively and efficiently and without delay. \nAre you prepared? \n\nIs your company prepared to perform a hazard analysis to determine the risk to consumers?\nAre you prepared to develop a recall strategy appropriate to the product\, distribution pattern and level of depth for the recall?\nAre you ready with press releases and prepared statements and a spokesperson to manage customer communications and the media?\n\nBad things can happen to the best of companies…. Even with a company’s strong commitment to cGMPs and safe practices\, product recalls can and do happen. Manufacturers today face a myriad of factors that can affect product quality and safety\, so there are lots of potential places for something to go wrong. More than 2\,500 product recalls occur in the United States each year\, according to Dirk Gibson\, an associate professor of mass communication at the University of New Mexico who has conducted extensive research on product recall practices. “Recalls are perennial. They are always out there\, so it’s something we ought to plan for.” \nManufacturers must be prepared with SOPs\, recall plans\, training and organization to handle a product recall. Private label marketers must prepare for the possibility of needing to recall a product in concert with their contract manufacturer partners. Recalls are never easy or simple and can strain an organization and potentially ruin a good product and a good company. \nA full-blown product recall is a complicated and highly regulated process\, with the potential for more than just bad press — legal complications also arise when a company realizes one of its products has the potential to cause harm or injury to consumers. To get an unsafe product off the market as quickly as possible and with minimal fallout to your customers and your reputation requires preparation\, preparedness and practice. \nFollowing cGMPs and being prepared are key to reducing your company’s risk of a product recall and an valuable investment in protecting your company\, your products your business and your customers. \nIt is critical that you are prepared. \n\nYou will need a recall SOP with a detailed recall plan and department and individual responsibilities.\nYou will need to have practiced. In order for your recall team to be effective they will need to conduct a mock recall annually. If you are a private label distributor you will need to work with your manufacturer to conduct these training exercises.\nManufacturers\, you will need to be prepared to perform a root cause analysis to determine the process failure or failures that may have led to the product failure and recall.\nYou will need to investigate to determine what went wrong and how many products and batches could be affected.\nYou will need to be able to track the product through the sales channel\, and recall from distributors\, practitioners and stores. You may have to advertise to notify consumers that they should discontinue use and return unused and partial packages. Remember 100% recall product recovery is the goal.\nYou will need to have swift and effective communications with your customers and the media.\nYou will need prepared messages to communicate the reason for the recall and the actions distributors\, stores and consumers need to take to return the products to you.\nYou will need to accomplish a through accounting for all of the recalled products.\n\nThis Webinar Covers:\n\nWhat the cGMPs require of manufacturers in the event of a recall\nWhat to include in SOPs for product recalls\nHow to organize management\, staff\, distributors\, contract manufacturing partners and PR in the event of a recall\nHow to prepare company messages\, press releases and customer letters\nAbout the need and value of performing mock recalls\n\nWe all hope to never have to implement such a program\, yet the costs of being unprepared if the situation arises could turn an inconvenience into a crises! \nNote: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training. \nMeet Our Presenters:\nAvril Bland of PSC Biotech\, is a consultant to the food and drug industries with extensive experience in FDA cGMPs and compliance requirements within the drug industry and speaking about the requirements for SOPs\, inventory management and conducting mock recalls. \nSteve Edwards of Expert Recall* Stericycle will provide an overview of recall management with the extensive experience on how to streamlines the entire product recall process\, manage FDA regulations\, help to determine the best course of action and help to track and report recall progress. \nCynthia Batterman is the Principal and Chief Trailblazer at Essex Consulting and Vice President at AAHP. Her extensive background in management and marketing for Nelsons\, ConAgra Foods and Masterfoods makes her well qualified to discuss the need for well crafted press messages for the media\, industry and consumers. \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount. \n[button color=”blue” url=”mailto:info@theaahp.org?subject= How to Survive a Product Recall Webinar Archive Inquiry” size=”small”]Click here to order.[/button] \n  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:20260418T074501 CREATED:20140127T200313Z LAST-MODIFIED:20150123T182729Z UID:10000058-1420416000-1515110399@theaahp.org SUMMARY:FDA Hot Topics - Webinar Archive DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nCurrent FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated: all raw materials must receive at least an ID test to confirm it is the correct material according to the HPUS\, USP or other appropriate authority. Marketing companies have received warning letters about labeling controls and inventory practices. Manufacturers have been issued warning letters and FDA-483 inspection reports for failure to adequately control incoming materials including quarantine\, release\, evaluation and identity testing. \nThis webinar provides an overview for marketers and manufacturers of the regulations establishing the requirements for components\, raw materials and labeling\, starting with the establishment of specifications and covering receiving\, sampling\, evaluation and testing for release or rejection. The FDA has made written specifications\, identity testing and labeling controls a mandate in its inspection of manufacturers. Manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance. Failure to follow these regulations can result in the issuance of FDA warning letters and product recalls. \nCompliance in these critical quality areas is essential to the identity\, quality and safety of homeopathic products and is the responsibility of private label marketers and manufacturers alike. Sometimes\, an innocent action is actually a critical lapse of compliance. For instance: \nIs it acceptable for a firm to use drug components\, drug product containers\, or drug product closures simultaneously with testing and/or prior to determination of conformity to all specifications? {References: Federal Register Vol.43 No. 190\, 9/29/78\, 45013 [at 45045]} \nNo. It is not acceptable to use drug components containers\, or closures prior to completion of all testing to determine conformance to established written specifications. The above preamble to 21 CFR 211.84\, clearly states that the use of drug components\, containers\, or closures prior to completion of testing for conformity to specifications violates the precept of good quality control because untested and possibly non-compliant materials would be used in drug product processing. This type of procedure substantially increases the risk to the consumer that an unsatisfactory lot might erroneously be released. {From FDA Human Drug CGMP Notes\, Vol. 4\, No. 4\, December 1996 The Division of Manufacturing and Product Quality\, HFD-320\, Office of Compliance\, CDER\, Project Manager: Paul J. Motise\, HFD-325.} \nThis webinar presents an overview of FDA cGMP and Homeopathic Pharmacopoeia requirements for testing of packaging components and active ingredients. The webinar is designed as a compliance overview for private label marketers and manufacturers and will address the regulations for conformance of homeopathic drug products. Compliance with 21 CFR 211 Subpart E\, for raw materials\, is critical to product quality and safety. Manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance. \nExample of observations in recent FDA 483’s for failure to identity test raw materials: \n\nYou did not follow your written procedure\, “Approval/Rejection of Raw Materials and Packaging Components” for collecting representative samples of each unique shipment of components. Under 21 CFR Subpart E\, you must establish and follow written procedures for fulfilling the requirements of subpart E. This subpart includes the requirement that you collect representative samples of each unique lot of components (21 CFR 211.80).\nThe inspection revealed the following deficiencies: 1. You failed to determine whether specifications are met before use of components as required by 21 CFR 211.84. Specifically\, you failed to conduct at least one appropriate test or examination to verify identity of a drug ingredient prior to its use. From the time period between June 25 and October 6\, 2009\, you did not perform identity testing on any drug ingredients that you received\, and during the time period between October 6\, 2009 and May 10\, 2010 you only performed identity testing on randomly selected drug ingredients.\nYour firm failed to reject any lot of components that did not meet the appropriate written specifications for identity\, strength\, quality and purity [21 C.F.R. § 211.84(e)]. For example\, a [redacted] raw material (lot (b)(4)) failed to meet specifications and was not rejected. The raw material was subsequently used to manufacture [redacted] (b)(4)). These lots were released and distributed.\nFailure to verify the identity of each component of a drug product\, as required by 21 C.F.R. § 211.84(d)(1). Components used in all drug products are not tested for identity. For example\, the active ingredient [redacted] USP\, used in [redacted]\, batch (b)(4) was not tested.\nFor example\, your firm does not have a sampling and test procedures designed to assure that the water from the purification system conforms to appropriate standards.\nYour firm failed to conduct at least one appropriate test or examination to verify the identity of a drug ingredient prior to its use\, to comply with 21 CFR 111.75(a)(1)(i).\nThe CGMP deviations documented during the inspection include\, but are not limited to\, the following: Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture\, processing\, packing\, or holding of drug products\, as required by 21 CFR 211.160(b)(1).\n\nThese recent FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated that all raw materials must receive at least identity testing to confirm it is the correct material according to the HPUS\, USP or other appropriate authority. Marketing companies bear responsibility to ensure that their products are manufactured under cGMPs and have received warning letters about labeling controls and inventory practices\, and for failure to adequately control incoming materials including quarantine\, release\, evaluation and identity testing. All homeopathic drug manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance. \nIn this Seminar you will learn the importance of…\n\nProtecting your consumers and your business by meeting the FDA regulatory requirements for specifications\, receiving\, testing and evaluating components\, labeling and raw materials\nEnsuring product quality with the establishment of material and component specifications\nConfirming raw materials with required identity testing\nCompliance with FDA ‘hot button’ inspection issues\n\nNote: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training. \nWho should view this webinar?\n\nManufacturers\, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.\nQA/QC staff responsible for establishing specifications\, sampling\, evaluating and testing of components and materials.\nMarketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality\, safety and labeling.\nPersonnel required to maintain appropriate and documented training in current Good Manufacturing Practices.\n\nMeet the Presenters:\nRachael Carlisle Roehrig\, Ph.D.–Director of Technical and Scientific Affairs for the Regulatory and Scientific Affairs department of the Consumer Healthcare Products Association (CHPA)\, coordinator for CHPA’s Product Quality & Operations Workshop and the CHPA liaison to the Manufacturing Controls Committee. Rachael presents FDA regulations 21CFR 211 Subpart E – Control of Components and Drug Product Containers and Closures and requirements. She will discuss specific quality processes\, requirements for specifications\, documentation and required identity testing. \nEric Foxman\, RPh—Executive Secretary for the AAHP\, Board Member of the HPCUS\, and consultant on regulatory and GMP issues with over 30 years of involvement in homeopathic pharmacy and manufacturing. Eric discusses the HPUS requirements for testing of starting materials\, botanicals and chemical substances\, and for finished tinctures\, providing examples of material specifications and identity testing requirements.\n \nKevin Carrasco—VP\, Speed Laboratory Inc Kevin will review the reasons for the use of USP and NF testing methods for most excipient and for some homeopathic ingredients. He presents examples of the identity testing requirements for some of the most common homeopathic product excipients and active ingredients and cover basics in good laboratory practices for manufacturers. \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount. \n[button color=”blue” url=”mailto:info@theaahp.org?subject= FDA Hot Topics Webinar Archive Inquiry” size=”small”]Click here to order[/button] 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:20260418T074501 CREATED:20140604T182228Z LAST-MODIFIED:20150123T182402Z UID:10000052-1420329600-1515110399@theaahp.org SUMMARY:Homeopathic Market – Consumer Trends and Insights Webinar Archive DESCRIPTION:The market for homeopathic and herbal remedies continues to grow. Due to increased healthcare costs and insurance issues\, more consumers are proactive about their health and wellness. This\, paired with the fact that consumers are using more organic and natural products\, could help fuel the growth of homeopathic remedies. Furthermore\, product recalls of various OTC nonprescription medications likely have consumers looking for what they perceive to be as “safer alternatives”. How can your company benefit from the research and information that already exists about this market that is essential to your company? \nMintel\, the leader in consumer research\, presents information on the homeopathic drug market based on their broad and deep reach into the research on consumer choices and trends. Mintel’s Health and Wellness Analyst\, Emily Krol\, presents key findings and insights gleaned from their extensive 120 page 2013 report\, Homeopathic and Herbal Remedies. Emily also draws upon Mintel’s 2011 similar report for a longer range overview of emerging trends. \nView the AAHP presentation on Mintel’s research and conclusions on the homeopathic market and learn more about your customers and their natural health needs and preferences as well as gaining an understanding of important trends in the market. This 45 minute webinar will provide you with a concise overview of important information contained in Mintel’s extensive market research report. \nWho should view this Webinar Archive? \n\nOwners\, CEOs and management responsible for overall market and sales growth.\nMarketing managers and staff responsible for marketing campaigns and new product launches.\nManufacturers\, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.\nMarketers of private label brands responsible for marketing their homeopathic products.\n\nWebinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road\, Milwaukie\, OR 97222.  The cost of the DVD Archive is $179 (includes S&H); AAHP members get a $90 discount. \nLimited Time Special Package Pricing: order this DVD plus the Analytical Tools for Understanding Webinar Archive at the same time and get both for $269 (includes S&H). That’s a savings of $90 over ordering them separately.  AAHP Members save even more: order both at the same time and get a $130 discount. \nNote: The 2013 Mintel report\, Homeopathic and Herbal Remedies can be purchased directly from Mintel Corporation at http://store.mintel.com/homeopathic-and-herbal-remedies-us-march-2013. A copy of the report will not be included in the Webinar handouts. \n[button color=”blue” url=”mailto:info@theaahp.org?subject=Consumer Trends 2014 Webinar Archive Inquiry” size=”small”]Click here to order.[/button] URL:https://theaahp.org/event/homeopathic-market-webinar-on-consumer-trends-and-insights/ LOCATION:Webinar Archive CATEGORIES:Webinar,Webinar Archive END:VEVENT END:VCALENDAR