(July 26, 2006, Silver Spring, MD) -- To help you plan in this evolving regulatory world, the American Herbal Products Association (AHPA) presents its first in a series of educational tele-seminars on August 3: Introduction to Good Manufacturing Practices for Dietary Supplement Products: Strategies for Compliance. For a detailed course outline click here: http://www.ahpa.org/portals/0/pdfs/AHPA_cGMP_Compliance.pdf
Get advice and documents from a panel of experts who are actively involved in all aspects of dietary supplement GMP. This is a unique opportunity to get your specific regulatory, quality, and process questions answered.
Meet Your Experts:
- Carl Reynolds, Senior Consultant, AAC/Kendle Regulatory Affairs — Carl joined the AAC/Kendle in 1999 after a career of more than 36 years with the FDA. His current duties include conducting audits of food, pharmaceutical and nutritional supplement manufacturers. He is a specialist in the area of dietary supplement GMP and was considered one of the early FDA experts in HACCP implementation. In his final role at the FDA, he served as the Director of the Office of Field Programs at the Center for Food Safety and Applied Nutrition (CFSAN). He was the center contact for all food borne illness emergencies and outbreaks and represented the FDA and CFSAN at both international and domestic meetings and training events.
- Mary Beth Watkins, BS, MS, Director of Quality and Compliance for Botanical Laboratories, Inc. — Mary Beth oversees the quality control department, analytical laboratory and quality assurance and compliance groups. Responsibilities include all quality functions, label and GMP compliance and QA audit management. She also continues her research work in new product development and formulation for dietary supplements and homeopathic drugs. She has spent 25 years in the natural products industry concentrating on quality and new product development. This time has included working with Heel/BHI as the QC/QA manager concentrating on GMP and label compliance and the Homeopathic Research Institute as Project Coordinator. She is the President of the American Association of Homeopathic Pharmacists and an AHPA board member.
- Michael McGuffin, President of AHPA — Michael has been active in the herbal industry since 1974, having owned both retail and manufacturing businesses in this field. He is the managing editor of AHPA’s Botanical Safety Handbook (1997) and of Herbs of Commerce, 2nd Edition (2000). He has represented the herbal industry at state and federal hearings on regulatory issues and has twice served on a working group and a subcommittee of FDA’s Food Advisory Committee. He also serves on the boards of the American Herbal Pharmacopoeia, the Dietary Supplement Education Alliance, and United Plant Savers and as an advisor for the University of Southern California School of Pharmacy's Regulatory Sciences Program, and chairs the Industry Committee of the Plant Conservation Alliance/Medicinal Plant Working Group, and represents AHPA at Conferences of the Parties to CITES.
If you have questions for the panel in advance of the event, please email them to Devon Powell: [email protected].
How to Register:
Date: August 3, 2006 // Time: 1pmET – 3pmET
Where: Your telephone or office conference room
Cost: $195 per line for members / $495 per line for non-members (unlimited participants!)
- Includes an unedited transcript
- Certification of Completion, for GMP compliance training and personnel files
- Additional certificates $25 each
- Audio CD will be available for an additional $25
Registration: Register with this online form to fax or email back: http://www.ahpa.org/portals/0/pdfs/06_08_AHPA_cGMP.xls. Advance registration only; the deadline is one day prior to the event. Once registered, a confirmation email will be sent to you and all supporting resource documents and instructions will be sent by email prior to the event. Any questions? Please contact Devon Powell at [email protected], or 301-588-1171, x102.
AHPA has prepared two other related GMP tele-seminars:
Botanical Identity/Herb Quality on September 28, 2006
The Quality Unit in early November 2006
Mark your calendar and register today!