Published: Saturday, July 7, 2007
If you’ve started to read the new good manufacturing practice rules (cGMPs) for dietary supplements, you’ve already got questions. Chances are, AHPA has already answered them in this educational event that will help you learn exactly what you need to know about the new cGMPs, including the necessary processes and procedures to comply when they go into effect. Course materials include AHPA’s Annotated Final Rule on Dietary Supplement cGMP, an easy-to-read document that presents key points and comments made by FDA in the preamble to the final rule next to the relevant sections. Speakers include the head of the Food and Drug Administration (FDA) dietary supplement program that wrote the new regulations as well as respected industry professionals who were deeply involved in reviewing and commenting on the cGMPs when they were proposed in 2003.
- Vasilios H. Frankos, MS, PhD, director of Division of Dietary Supplement Programs in the FDA's Center for Food Safety and Applied Nutrition — responsible for the full implementation of the DSHEA Act of 1994, Dr. Frankos directs and coordinates policy and administrative activities within the Division. Dr. Frankos advises on policy and management issues on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practice, adverse reaction monitoring, and related activities pertaining to dietary supplements.
- Marc Ullman, Esq, partner with the law firm of Ullman, Shapiro & Ullman — specializing in food, drug, and cosmetic law, he also provides legal services to his clients in many other areas, including litigation support and trademark/copyright matters. Mr. Ullman’s practice includes representation relating to FDA compliance — including labels, labeling, claims, good manufacturing practices, and adversarial proceedings relating to the scope of the agency’s powers under DSHEA.
- Michael McGuffin, president of the American Herbal Products Association — Active in the supplement industry since 1975, having owned both retail and manufacturing businesses, Mr. McGuffin has been AHPA’s president since 1999. He has represented the herbal industry at state and federal hearings on herbal regulatory issues and as a member of various FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements, and the Dietary Supplements Subcommittee of the FDA’s Food Advisory Committee.
- Event Facilitator: Tony Young, Esq, partner with the law firm of Kleinfeld, Kaplan & Becker
- AHPA’s Annotated Final Rule on Dietary Supplement cGMP
- Copies of the cGMP rules as published in 2003 and 2007
- Comparison of current good manufacturing practice regulations
- Presentations from all speakers
- Written transcript, including answers to questions posed by attendees that were not addressed during the event for lack of time
- Course Outline & Speakers Bios
- NO Audio file is available for this seminar. We sincerely apologize for any inconveniences.
Member Price: $220.00
Non-Member Price: $520.00
The Botanical Safety Handbook, Second Edition includes:
- Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
- Information on adverse events reported in clinical trials or case reports
- Safety-related pharmacology and pharmacokinetics of each herb
- Additional information on the use of herbs by pregnant or lactating women
- Toxicological studies and data on toxic compounds
- Extensive references for each entry
The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:
Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online
Member annual subscription: $95.00
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.