Webinar Recording: Debriefing the FDA’s cGMP Implementation Seminar

Presented: October 25, 2007

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Published: Thursday, October 25, 2007

In October 2007, four months after publishing the current good manufacturing practice (cGMP) regulations for dietary supplements in June, the Food and Drug Administration held a multi-media educational event for stakeholders. During that event, FDA gave some interesting and sometimes surprising insight into how they intend to implement the new cGMP rules. AHPA was ready the very next day with this debriefing that offers expertise to answer specific questions and dispel any confusion that arose from the FDA overview. This important event offers the insight you need to comply with the regs and stay in business! 

AHPA understands that the cGMPs will affect your business in many ways, and that some of these regulations are complicated. To ensure you have the knowledge and tools to comply, AHPA offers its expertise to answer specific questions. In order to comply and stay in business, learn from AHPA President Michael McGuffin and AHPA’s general counsel, Tony Young, Esq.

Both have closely scrutinized the GMPs throughout their development, understanding their practical applications and legal details and providing comments on behalf of industry to shape their final form.

Both have also participated in AHPA’s ongoing series of educational tele-seminars on GMPs.

McGuffin authored AHPA’s Annotated Final Rule on Dietary Supplement cGMP, which links key points and comments found in FDA’s lengthy preamble to the final GMP rule to each specific section of 21 CFR 111 to which it applies.

Course materials include:

  • Audio file of the AHPA event
  • An unedited transcript of the AHPA event
  • Links to FDA’s archived webcast

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.

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