The American Association for Homeopathic Products

2020 Membership Meeting
2020-03-06 | Clarion Hotel, 616 Convention Way, Anaheim, CA, 92802, United States
AAHP ANNUAL MEMBERSHIP MEETING

WHEN
Friday, March 6, 20208 – 11 AM

WHERE
The Carion Hotel616 Convention WayAnaheim, CA 92802

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.
All members are encouraged to attend; there will be updates on the FDA Draft Guidance document (the comment period will end just weeks after the annual meeting) as well as the AAHP’s perspective on what issues may be a particular focus for the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.
Board 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.
Mark your calendar. More information and details regarding the meeting will follow.
Members unable to attend in person can participate by video/audio dial in. Details will send distributed the week of the Annual Meeting.

AAHP Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products: Keeping Your Business Compliant under FDA’s New Proposed Guidance
2019-06-27 - 2019-06-28 | The Hilton Baltimore, 401 W. Pratt Street, Baltimore, MD, 21201
About the Summit
Now 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.
FDA 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.
Don’t miss this powerful one-day investment — especially if your company will be present in the exhibit hall for the Joint American Homeopathic Conference.
Who Should Attend
Recommended 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.
Quality Staff
Event sponsor

Quality Assurance
Quality Control

Safety Staff

Pharmacovigilance
Medical
Toxicologists

Regulatory Staff

Legal
Marketing

What You Will Learn

How hot-button policy issues may impact your company’s bottom line
How best to prepare for FDA’s new enforcement priorities
Save time and money developing a compliance strategy at small group workshop with access to in-depth experts to ensure business operations
Gain insight into important compliance procedures
Network with the largest gathering of the American homeopathy community at the 14th annual Joint American Homeopathic Conference’s Reception.
Knowledge Leaders
AAHP 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.
Quality Track Leader

George Bernstein, PhD
President, MAI Consulting
www.ConsultMAI.com

Dr. 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.
Regulatory Track Leader
Ann M. Begley
Partner, Morgan, Lewis & Bockius LLP
www.MorganLewis.com
Based 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.
Inaugural Industry Reception – Thursday, June 27th
Where: Hilton Baltimore Carroll Room overlooking Camden Yards
AAHP’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.
Speakers
Scott Emerson
Founder & CEO, The Emerson Group
Mr. 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.

Workshop Speakers – Friday, June 28th

Review the three tracks below, followed by a detailed schedule.
Opening Keynote
Presented by:
Francis Godwin, MBA
Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
After 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.
Track 1: Quality
Establishing Analytical Specifications
This 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.
Presented by:
Stephanie Chanut
Analytical Methods Development Laboratory Manager, Boiron France
See Workshop Summary
Process Validation

This 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.

Co-presented by:
Eric Baier
Senior Vice President Quality, Hyland’s and

John Schottig
Director of Process Validation, Hyland’s
See Workshop Summary
Finished Product Testing / Content Uniformity

As 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.
Presented by:
Fanny Guillot
Analytical Method Development, Boiron France
See Workshop Summary

Track 2: Safety
Pharmacovigilance
This 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.
Presented by:
Richard Kingston, PharmD
President, Regulatory and Scientific Affairs, SafetyCall International, PLLC
See Workshop Summary

Industrial and Regulatory Toxicology
Part I: Principles of Toxicology
The 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.
Part 1: See Workshop Summary
Part II: Application of General Toxicology Studies to Support Regulatory Requirements
Building 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
Presented by:
Matthew D Reed, PhD, DABT, Fellow ATS
Principal, Coelus LLC
Part 2: See Workshop Summary

Track 3: Regulatory
Homeopathic Product Substantiation—Concept to Shelf

Learn 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.
Presented by:
Susan J. Hewlings, PhD, RD
Director, Scientific Affairs, Nutrasource
Professor, Central Michigan University
See Workshop Summary
Topics in Labels and Labeling
How 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.
Presented by:
Eric L. Foxman, RPh
Regulatory Consultant
Secretary, AAHP
Senior Scientist, HPCUS
See Workshop Summary
Enforcement Hot Topics

Prepare 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.
Presented by:
Mark Land, MS, RAC
VP, Government & Regulatory Affairs, Boiron USA
President, AAHP
See Workshop Summary

Registration
Registration is separate for the Summit and the Reception.
Click Here to Register for the Reception!
Click Here to Register for the Summit!
Opening Reception, June 27th

Team Rates

Early Registration

Full Registration

Member
Non Member

Member
Non Member

1st Attendee

$250
$395

$295
$500

2nd Attendee

$200
$295

$250
$395

3rd Attendee

$175
$250

$200
$295

AAHP Summit, June 28th

Team Rates

Early Registration

Full Registration

Member
Non Member

Member
Non Member

1st Attendee

$1000
$1,300

$1,200
$1,500

2nd Attendee

$900
$1,100

$1,000
$1,300

3rd Attendee

$800
$1,000

$900
$1,100

Academic Rate

$595

Government Rate

$695

Schedule
Thursday, June 27, 2019
5:00–7:00 p.m. Opening Reception in the Hilton Baltimore Carroll Room, overlooking Camden Yards

Friday, June 28, 2019

8:00–9:00 a.m.
Registration Open

9:00–10:00 a.m.

Opening Session: Scott Melville, Consumer Health Products Association

10:00-10:15 a.m.

Morning Break with JAHC Attendees

Quality Track

Safety Track

Regulatory Track

10:15–11:45 a.m.
Establishing Analytical Specification
by Stephanie Chanut
Boiron France
Pharmacovigilance
by Richard Kingston, PharmD
SafetyCall International, PLLC
Claims Substantiation
by Susan J. Hewlings PhD, RD
Nutrasource

11:45–1:00 p.m.

Networking Lunch

1:00–2:30 p.m.
Process Validation
by Eric Baier & Karl John Schottig
Hyland’s, Inc., a division of Standard Homeopathic Co.
Methods in Toxicology
by Matthew D. Reed, PhD, DABT, Fellow ATS
Coelus, LLC
Topics in Labels and Labeling
by Eric L. Foxman, RPh
AAHP

2:30–3:00 p.m.

Afternoon Break with JAHC Attendees

3:00–4:30 p.m.
Finished Product Testing/Content Uniformity
by Fanny Guillot
Boiron France
Populations and Routes of Administration
Enforcement Hot Topics
by Mark Land, MS, RAC
AAHP

4:30–5:00 p.m.

Closing Session

5:00–6:30 p.m.
Joint American Homeopathic Conference Opening Reception (cash bar)

Booking Information
Click 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
Alternatively, call the hotel directly at 866-238-4218 and reference the Joint American Homeopathic Conference discounted rate.
The group block could sell out prior to the discount cut-off date of Tuesday, June 4, 2019. Booking your reservation early is strongly encouraged.
About Baltimore and the Hotel
For information on the hotel and surrounding area, please visit the website for the Joint American Homeopathic Conference.
https://www.jahc2019.org/hotel-information.html
The 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.
Sponsors
Presenting Sponsor
The Emerson Group
www.EmersonGroup.com
The 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.
Platinum Level Sponsors
Boiron
www.BoironUSA.com
In 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.

Hyland’s Inc.
www.Hylands.com
Founded 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.

MAI Consulting, Inc.
www.ConsultMAI.com
MAI 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.

Matrixx Initiatives, Inc.
www.Zicam.com
Matrixx 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®.

Nelsons
www.Nelsons.net
Company 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®.

Similasan Corp.
www.SimilasanUSA.com
Similasan 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.
Event Supporters
Eric L. Foxman Consulting
https://sites.google.com/site/ericlfoxman/home
Using 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.

Coelus LLC
www.CoelusBio.com
Our 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.

CPG Linkages, LLC
www.CPGlinkages.com
Connecting senior-level association, manufacturer and retailer executives through targeted 1:1 meetings, annual industry overviews, conferences and other opportunities to drive mutual business growth.

Live Webinar: 2018/2019 HPUS Updates
2019-05-15 13:00 - 14:00 (America/New_York) | MD
Compendial and Homeopathic Attenuation Changes
AAHP Compliance Thru Education Webinar, Wednesday, May 15, 2019
at 1:00 p.m. ET • 12:00 p.m. CT • 11:00 a.m. MT • 10:00 a.m. PT
HPCUS 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.
This 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.
Attend 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.
Whether 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!

WHO SHOULD ATTEND
Compliance Managers
Quality Control and Quality Assurance Mangers
Staff Responsible for Product Formulations
Staff Responsible for Product and Label Review
Marketing Staff
CEO’s and Senior Management

PRESENTER
For 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.
Many 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.

COST: $179. AAHP members save $90 with the discount code available from the AAHP office.

WEBINAR REGISTRATION
Registration will open shortly.

* Each Live Webinar registration is for one computer/phone connection.
* 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.
* 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.
* Each separate computer/phone connection requires its own registration.
For more information regarding the seminar, contact Eric Foxman by calling 1-503-659-2715 or by emailing info@aahp.info.

2019 Membership Meeting
2019-03-08 09:00 - 11:30 (America/New_York) | Clarian Hotel, 616 Convention Way, Anaheim, CA, 92802, United States
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!
The 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.
Homeopathic Product Substantiation—from Concept to Shelf
Since 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.
In 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.

Join 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:

substantiation per FTC and FDA guidance;
developing a substantiation file from concept to shelf;
what types of claims can be made;
navigating the regulatory environment while still providing products true to homeopathy.

Presenter
Susan J. Hewlings, PhD, RD
Director of Scientific Affairs, Nutrasource
Professor, Central Michigan University
Dr. 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

In addition to the main topic of discussion, the AAHP will also hold its annual Board elections.
The 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.
All members are strongly encouraged to have at least one representative present in person.
While 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

Live Webinar: U.S. & E.U. Regulations - The Impact of "the Other" on Your Homeopathic Business
2019-01-10 11:00 - 12:00 (America/New_York) | MD
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
Summary
Whether 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.
How 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?
Attend this important and timely webinar to:

Receive an overview of the regulatory frameworks for homeopathic drugs in the U.S. and E.U.;
Understand the fundamental differences between the U.S. and E.U. regulatory requirements; and
Gain insights into what you need to know for importing and exporting homeopathic drugs between the U.S. and E.U.

This 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.
Presenters
Steve Mann, Director of External Global Regulatory Affairs & QPPV, Nelsons

Steve 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.
Steve 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.
Eric Foxman, Consultant and Board Member, HPCUS
Eric 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.
Eric 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.
Who Should Attend?

American companies purchasing homeopathic materials from Europe
European companies shipping homeopathic materials into the U.S.
American companies exporting or interested in exporting homeopathic products to Europe
European companies importing American homeopathic products
Compliance managers
Purchasing managers
Quality managers
Those responsible for import/export

Cost
Nonmembers: $239
AAHP Members: $149 (With $90 discount available from the AAHP office)

Register Today!

Click Here to Register

Semiannual Membership Meeting
2018-09-14 09:00 - 11:00 (America/New_York) | Holiday Inn Baltimore-Inner Harbor, 301 West Lombard Street, Baltimore, MD, 21201, United States
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!
Doors 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.
Keynote Speaker:
Dr. Jermey Kees, founder and director, Center for Marketing and Consumer Insights, Villanova University
Dr. 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.

Please RSVP to info@aahp.info by Friday, Sept. 7 to ensure adequate seating for all guests.

Live Webinar: HPUS Updates 2017/2018
2018-05-16 13:00 - 14:00 (America/New_York) | MD
A Webinar on Compendial Definitions and Homeopathic GMPs changes
CLICK HERE TO REGISTER.
Wednesday, May 16, 2018
1:00 pm ET • 12:00 pm CT • 11:00 am MT • 10:00 am PT
The 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!

This 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.
Attend 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.
Whether 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.

Presenter
Eric 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.
For 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.
Many 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.

COST: Non Members: $199. AAHP members get a $90 discount code available from the AAHP office.

Semiannual Membership Meeting: March 2018
2018-03-09 09:00 - 11:30 (America/New_York) | Clarian Hotel, 616 Convention Way, Anaheim, CA, 92802, United States
One of the most important AAHP meetings in the last 15+ years.
The 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.
With 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.
AAHP 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.
AAHP 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.
In addition to the main topic of discussion, the AAHP will also hold it’s annual Board elections.
The 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.
Again, all members are strongly encouraged to have at least one representative present in person.
While 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.

2017 HPUS Updates: A Webinar on Homeopathic GMPs and Stability
2017-05-18 13:00 - 14:00 (America/New_York) | MD
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!
Attend 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.
PRESENTER: Eric Foxman, RPh, a founding member of the Homeopathic Pharmacopeia Convention of the United States.
COST: Non-Members: $199. AAHP members get a $90 discount code available from the AAHP office.
REGISTRATION: Please use the following link to register for this webinar. You will receive an email confirmation shortly after you complete the registration.
http://eventcallregistration.com/reg/index.jsp?cid=69840t11
For more information regarding the seminar, call Eric Foxman (1-503-659-2715) or by email: info@theaahp.org

The AAHP NetworkNews had a quick conversation with presenter Eric L. Foxman about what will be covered in the webinar.
NetworkNews: In a nutshell, what are you going to talk about?
Eric 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.

NN: What are those two documents?
ELF: 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.

NN: And the other document?
ELF: 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.

NN: What else will you address in the webinar?
ELF: 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.

NN: How long will the webinar be?
ELF: 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.

NN: This is the fourth webinar you have presented on the HPUS for the AAHP. How long have you been involved with the Homeopathic Pharmacopeia?
ELF: 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.

Semiannual Membership Meeting: March 2017
2017-03-10 09:00 - 11:00 (America/Los_Angeles) | Clarian Hotel, 616 Convention Way, Anaheim, CA, 92802, United States
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.
Held 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.
The 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.
Additionally, 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.
All AAHP members may attend the conference free of charge. See you in Anaheim!
*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.

Best Branding Practices Webinar Archive
2015-01-11 - 2018-01-10 | Webinar Archive
How to make your product stand out in a crowd: selling products, services and your company’s image.

The Homeopathic market place is estimated to have have reached $1 billion in sales in 2011 and is still growing!
Annual growth has been estimated at between 3 and 5%.
Branding your company, products and services to differentiate you from the crowd while accelerating your growth is now more important than ever.

Homeopathic 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.
Every 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.
This Webinar Covers

The latest information on what drives consumer trends and what consumers are saying about homeopathic products.
Defining and differentiating your brand – what is branding, how to define your brand and the art of standing out from the crowd.
Creating 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.
The emerging ‘New Media’ opportunities of the internet and social networking in brand and image building and management.
How to build a brand on any budget.

Who Should View…

Owners, CEOs and management responsible for band and company mission, image, sales and growth
Marketing managers and staff responsible for advertising, media and message
Designers and marketers responsible for product image, package design and labeling
Manufactures and service suppliers to the homeopathic industry for how to promote your services to the industry and maximize your company’s image and message

Meet the Presenters
Bob 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.
Cynthia 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.
Tara 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.
Danielle 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.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.
Click here to order

Managing Consumer Calls: Complaints, cGMP Compliance, Quality and Service Webinar Archive
2015-01-10 - 2018-01-09 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Customers 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.
Customer 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.
In 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.
The 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.
Ignoring 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.
Manufacturers 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.
Private 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.
Note: 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.
This Webinar Covers:

What the cGMP requirements are for marketers and manufacturers of drug products in managing consumer complaints;
How to conduct a thorough investigation of the complaint;
Importance and tools for investigating consumer complaints;
The requirements and value of performing corrective actions.

About Our Presenters
Alvin 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.
Mary 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.
Walt 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.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.
Click here to order

From Leaf to Label - Quality Throughout the Cycle -- Webinar Archive
2015-01-09 - 2018-01-08 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Anyone 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.
Vender 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.
Ensuring 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
The 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.
Webinar Covers:

vender qualification, quality audits
supplier assessment and performance and quality agreements
manufacturing processes, validation and packaging
finished product specifications; container, closure, label, product
testing for release

Note: 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.
Who Should View?

Owners, CEOs and management responsible for corporate compliance with FDA requirements.
QA/QC staff responsible for establishing specifications and testing of components.
Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.

Our Presenters:
Janeen 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
Pejman 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.
Steve 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.
This 2 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.
Click here to order

Managing Contract Manufacturing Responsibilities and Relationships Webinar Archive
2015-01-08 - 2018-01-07 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Don’t put your business at risk by not thoroughly understanding and implementing the responsibilities & duties of a contract manufacturing and marketing relationship!
The 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.
Managing 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.
FDA inspects both contract manufacturers and contract marketers. Here are examples of the FDA’s comments in recent months to contract manufacturers and marketers:

Contract 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.
Contract 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.
Contract Marketer – your firm failed to conduct an investigation into numerous consumer complaints associated with broken or damaged tablets and bottles.
Contract 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.
Contract 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.
Contract 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.

FDA 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.
Contract 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.
Note: 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.
Meet the Presenters
Three 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.
Cathy 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.
Robert 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.
Travis 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.

This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.

Click here to order

The Homeopathic Market – Analytical Tools for Understanding and Growth Webinar Archive
2015-01-07 - 2018-01-07 | Webinar Archive
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.
Now there is an opportunity to do just that!
IRI 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:
Consumer understanding – consumer analytics, marketplace insights, survey solutions
Growth and new product innovation – foresight, launch forecasting, product profiles
Marketing performance and management – market testing, price& trade advantages, analytics
Sales and channel management – shopper behavior, new products, packaging, pricing and promotion
Shopper –Centric Collaboration – insights, analytics, solutions loyalty
This 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.
Who should view this archive?

Owners, CEOs and management responsible for overall market and sales growth.
Marketing managers and staff responsible for marketing campaigns and new product launches.
Manufacturers, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.
Marketers of private label brands responsible for the marketing their homeopathic products.

Webinar 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.
Limited 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.

How To Survive a Product Recall Webinar Archive
2015-01-06 - 2018-01-05 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
It 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.
What the FDA Expects……
When 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.
Are you prepared?

Is your company prepared to perform a hazard analysis to determine the risk to consumers?
Are you prepared to develop a recall strategy appropriate to the product, distribution pattern and level of depth for the recall?
Are you ready with press releases and prepared statements and a spokesperson to manage customer communications and the media?

Bad 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.”
Manufacturers 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.
A 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.
Following 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.
It is critical that you are prepared.

You will need a recall SOP with a detailed recall plan and department and individual responsibilities.
You 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.
Manufacturers, 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.
You will need to investigate to determine what went wrong and how many products and batches could be affected.
You 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.
You will need to have swift and effective communications with your customers and the media.
You 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.
You will need to accomplish a through accounting for all of the recalled products.

This Webinar Covers:

What the cGMPs require of manufacturers in the event of a recall
What to include in SOPs for product recalls
How to organize management, staff, distributors, contract manufacturing partners and PR in the event of a recall
How to prepare company messages, press releases and customer letters
About the need and value of performing mock recalls

We 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!
Note: 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.
Meet Our Presenters:
Avril 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.
Steve 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.
Cynthia 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.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.
Click here to order.

FDA Hot Topics - Webinar Archive
2015-01-05 - 2018-01-04 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Current 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.
This 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.
Compliance 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:
Is 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]}
No. 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.}
This 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.
Example of observations in recent FDA 483’s for failure to identity test raw materials:

You 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).
The 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.
Your 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.
Failure 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.
For 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.
Your 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).
The 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).

These 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.
In this Seminar you will learn the importance of…

Protecting your consumers and your business by meeting the FDA regulatory requirements for specifications, receiving, testing and evaluating components, labeling and raw materials
Ensuring product quality with the establishment of material and component specifications
Confirming raw materials with required identity testing
Compliance with FDA ‘hot button’ inspection issues

Note: 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.
Who should view this webinar?

Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
QA/QC staff responsible for establishing specifications, sampling, evaluating and testing of components and materials.
Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.
Personnel required to maintain appropriate and documented training in current Good Manufacturing Practices.

Meet the Presenters:
Rachael 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.
Eric 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.

Kevin 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.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.
Click here to order

Homeopathic Market – Consumer Trends and Insights Webinar Archive
2015-01-04 - 2018-01-04 | Webinar Archive
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?
Mintel, 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.
View 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.
Who should view this Webinar Archive?

Owners, CEOs and management responsible for overall market and sales growth.
Marketing managers and staff responsible for marketing campaigns and new product launches.
Manufacturers, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.
Marketers of private label brands responsible for marketing their homeopathic products.

Webinar 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.
Limited 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.
Note: 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.
Click here to order.

Homeopathic Pharmacopeia -- 2013 Updates: What Might Affect Your Business Webinar Archive
2015-01-03 - 2018-01-02 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
The Homeopathic Pharmacopoeia of the United States, HPUS, as an official compendium recognized by the FDA, is critical to every manufacturer, formulator and contract marketer. You know the HPUS is a key reference for the manufacture of homeopathic medicines. But do you also know it is a continually updated and expanding guide? As the FDA continues to broaden its focus on the homeopathic industry, it is important to stay informed as changes in the HPUS are made.
This short, efficient web-seminar will help you to stay on top of these changing guidelines as it relates to your regulatory compliance. In this web-seminar, hear from the President of the HPCUS as to why the pharmacopeia is important to homeopathic manufacturing and marketing, and how to apply the guidelines to the legal and regulatory status of your homeopathic products under the FDA.
This Webinar Covers:

The most commonly used 12 dosage forms and HPUS guidelines for manufacturing and labeling each
Revised HPUS guidance for what should be on the labels of combination products
The variety of methods for making tinctures — beyond simple maceration
Updates to validated official quality control tests that can be used by QA labs.

Note: 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.
Who Should View?

Owners, CEOs and management responsible for overall corporate compliance with updated HPUS guidance and FDA requirements.
Marketing managers and staff responsible for compliant labeling.
QA/QC staff responsible for establishing specifications and testing of components.
Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.

If you are responsible for

overall corporate compliance (HPUS & FDA)
compliant labeling
for establishing specifications and testing of components
ensuring the compliance of homeopathic products
the compliance of your contract manufactured product’s quality, safety and labeling

… then this webinar is worth 1 hour of your time to stay abreast of these changes and their impact on your business.
Meet the Presenters
John P. (Jay) Borneman, PhD, President HPCUS is the fourth generation of his family in the profession of homeopathic pharmacy and has been associated with homeopathic pharmacy throughout his life. He is a principal owner of Standard Homeopathic Company and also serves as CEO of Hyland’s, Inc., the company’s wholly owned distribution subsidiary. Dr. Borneman serves on the Boards of the Homoeopathic Pharmacopoeia Convention of the United States as its President, Consumer Healthcare Products Association as Chairman of the CHPA Political Action Committee, Southwest College of Naturopathic Medicine; and as an emeritus director of The National Center for Homeopathy. He is has chaired the Legal and Regulatory Affairs Committee of the American Association of Homeopathic Pharmacists since 2001.
Eric L. Foxman, R.Ph. Senior Scientist HPUS attended his first Homeopathic Pharmacopia meeting in 1978 and has been a member of the HPCUS since its inception. In the interim, he has chaired the Pharmacopia Revision Committee, been an active member of the Standards and Controls committee since it’s formation and is presently chair of the Council on Pharmacy, while also serving on the Board of Directors of the Convention. Over the last 7 years, he has worked with the members of the Council on Pharmacy to completely review and revise the General Pharmacy Section of the HPUS leading to the creation of the all-new Guidelines for Manufacturing Homeopathic Medicines, new Labeling Guidelines and a revision of the Homeopathic Good Manufacturing Practices Guidelines. Concurrently, Eric has been a member or company representative of the American Association of Homeopathic Pharmacists for 35 years, and is presently serving his third stint as Secretary of that organization.
This 1 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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 $159 (includes S&H); AAHP members get a $50 discount.

Click here to order

Homeopathic Labeling: The FDA Is Watching - Webinar Archive
2015-01-02 - 2018-01-02 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
More than at any other time, the FTC and FDA continue to increase their scrutiny of homeopathic drug labeling and advertising. In order to protect your consumers, your brands, and your business, it is critical to have a thorough understanding of regulatory requirements.
This webinar provides a comprehensive overview of the requirements of the FDA Compliance Policy Guide for Homeopathic Drug Products, the HPUS Labeling Guidelines, and the regulations governing drug labeling and claims across the marketing mix, from product labels to websites to advertising.
In This Webinar Archive You’ll Learn How To:

protect your consumers, products, brands, while avoiding costly errors by complying with all HPUS and required FDA labeling requirements.
ensure your label has the required Drug Facts panel and warnings, and that you have the necessary substantiation and controls necessary for all claims.
create advertising, websites, POS, and other communications that maximize competitive advantage while adhering to the required labeling regulations.
distinguish OTC from Rx claims.

Note: 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.
Who Should View:

Manufacturers, private label producers, distributors, and or marketers of homeopathic products.
QA/QC professionals, marketing/PR staff, packaging/regulatory managers, and executives who manage or oversee labeling, consumer communications, and/or risk management.

This efficient 2.5 hour webinar archive features an expert panel of noted homeopathic industry consultants discussing the current regulatory guidelines, potential pitfalls to avoid, developing corporate guidelines/GMPS, as well as an Question and Answer period to addresses individual issues:
Meet the Presenters
Al Lorman Esq — AAHP counsel and authority on the Compliance Policy Guide. Al provides an overview of the FDA & FTC Advertising Review Process, an overview of recent enforcement actions and warning letters, and provides guidance for avoiding these mistakes. He also discusses OTC vs. Rx claims, and regulation of products containing both homeopathic and other allopathic drugs or supplements.
Eric Foxman, RPh –Secretary for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 35 years of involvement in the homeopathic pharmacy and manufacturing. Eric discusses the labeling requirements of the HPUS, the drug facts statements, and critical points regarding label formats and dosing, as well as requirements for marketing to adults vs. children.
George Bernstein PhD — Pharmaceutical consultant improving the efficiency, compliance, and quality of small, medium, and large domestic and global pharmaceutical companies. George provides guidance on creating a claims substantiation file, on using all the correct warnings for safety and specific condition claims. He also reviews proper cGMPs of labeling, approvals/sign off, change control, revision numbers, and label inventory controls.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar 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.
Click here to order.

Homeopathic Pharmacopeia – 2014 Updates – Is Your Company Ready? Webinar Archive
2015-01-01 - 2018-01-01 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
In 2014, the Homeopathic Pharmacopeia Convention of the United States (HPCUS) completed another round of updates building on the changes that were drafted in 2013 and approved for final publication in April of that year. In addition to the finalized and approved Guidelines for Manufacturing Homeopathic Medicines, four new documents were posted for public comment, as well as 6 new monographed substances. This webinar archive provides an orientation to these changes as well as discusses the implementation schedule for the guideline documents.
Three members of the HPCUS present overviews of the approved changes and the public comment period for the draft documents. Eric Foxman has been deeply involved in the drafting and revisions of these important guideline documents for the past several years. He is joined by AAHP Board member Mary Beth Watkins, who has been leading the drafting of a brand new guideline document on Homeopathic Drug Stability Guidelines. The third presenter will be Eric Baier, a member of the HPCUS Council on Pharmacy, where he chaired the ad hoc subcommittee that created an updated Homeopathic Labeling Guideline document.
View this AAHP presentation on the 2014 changes and proposed updates to the HPUS. This 90 minute webinar archive will provide you with a concise overview of important information contained in the new guideline documents as well as giving you insights into how comments on the proposed changes can be submitted to the HPCUS. The Archive DVD contains all the handouts available during the original on-line event.
Note: 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.
Who should view this webinar?

Owners, CEOs and management responsible for regulatory compliance.
Staff responsible for compliant labeling.
QA/QC personnel who need to know the guidance information provided by the HPUS for stability assurance.
Manufacturers, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.
Marketers of private label brands responsible for compliant labeling of their homeopathic products.

Webinar 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 $239 (includes S&H); AAHP members get a $100 discount.

Click here to order.

Members’ Meeting Is Just Around The Corner
2014-09-19 09:00 - 11:30 (America/New_York) | Holiday Inn Baltimore-Inner Harbor, 301 West Lombard Street, Baltimore, MD, 21201, United States
Plan to attend the AAHP’s Semi-Annual Membership Meeting in Baltimore, MD on Friday, September 19. We plan on giving our members updates on our activities as well as a special presentation during the meeting. More information will follow in a future NetworkNews.
As usual, the meeting will be held in conjunction with Natural Products ExpoEast, on Friday morning, September 19 in the Holiday Inn Downtown Hotel. This is the same location as our last two September meetings, and is located at 301 West Lombard Street, just a block from the Convention Center. Accommodations in Baltimore are going fast, so be sure to get your overnight rooms soon so you can attend.
