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Thursday, October 02, 2014

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  Debriefing the FDA's cGMP Implementation Seminar

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, Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry. 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

       
 



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