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Published: Tuesday, December 13, 2016
Date: Tuesday, Dec. 13
Members - $199
Non-Members - $499
This webinar helps businesses in the dietary supplement industry understand the elements of 21 CFR 111 / current Good Manufacturing Practices (cGMP) regulations that have been the focus of recent FDA inspections. This knowledge will assist business to ascertain their own compliance status.
Veteran industry legal experts provide attendees with an insider’s view of the current cGMP enforcement landscape. AHPA staff offer a detailed analysis of the association’s repository of inspection data, widely regarded as the most in-depth in the industry. That analysis is based on actual FDA 483 Notices of Observations and establishment inspection reports (EIRs). A summary of the AHPA’s data collection process, a review of the data and detailed examples is also be provided.
A 20-30-minute Q&A session follows the speaker presentations to answer specific questions about FDA inspections, enforcement actions, and related matters.
Jennifer M. Adams, Esq., Associate, Amin Talati & Upadhye