FDA Inspections & Emerging cGMP Compliance Issues

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FDA Inspections & Emerging cGMP Compliance Issues

Presented May 15, 2014

Published: Wednesday, July 2, 2014

The American Herbal Products Association (AHPA) presented a two-hour educational teleseminar, “FDA Inspections and Emerging cGMP Compliance Issues for Dietary Supplements,” on Thursday, May 15, 2014.

A regularly occurring event and part of the association’s cGMP Compliance Series, this two-hour, audio-only teleseminar is designed to help businesses in the dietary supplement industry understand the elements of 21 CFR 111/current Good Manufacturing Practices (cGMP) regulations that are most focused on during recent FDA inspections. This knowledge will assist business with better allocating their compliance resources.

Veteran industry legal experts provide attendees with an insider’s view of current cGMP enforcement landscape. AHPA staff offers a detailed analysis of the association’s repository of inspection data, widely regarded as the most in-depth in the industry and which includes actual FDA 483 Inspection reports, Observation forms, and establishment inspection reports (EIRs).

Topics

  • Manufacturer vs. contract manufacturer vs. supplier vs. brand marketer: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • FDA “Hot buttons” during inspections and what can be done to prepare and mitigate 
  • Detailed analysis of recent (2013-present) FDA inspection reports
  • What the inspection reports teach and how to appropriately respond to a Form FDA 483
  • Answers to your questions during the Q&A session

Presenters

  • FDA legal expert panel:
    • Tony Young, Kleinfeld, Kaplan & Becker/AHPA General Counsel
    • Justin Prochnow, Greenberg Traurig
    • Ashish Talati, Amin Talati
    • Marc Ullman, Ullman, Shapiro & Ullman
  • AHPA Information Analyst Merle Zimmermann, Ph.D., who will provide a detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.
A 20-30 minute Q&A session follows the speaker’s presentations to answer specific questions about FDA inspections, enforcement actions, and related matters. 

Cost

  • AHPA Members: $220.00
  • Nonmembers: $520.00

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