FDA Inspections, Warning Letters and Emerging cGMP Compliance Issues

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FDA Inspections, Warning Letters and Emerging cGMP Compliance Issues

Learn the elements of 21 CFR 111 / current Good Manufacturing Practice (cGMP) regulations that FDA inspections have been focusing on recently

Author: Haley (Admin)/Tuesday, December 13, 2016/Categories: AHPA News Release, Legal Alert, Market Alert, News Release, Update, Event Promotion, Events - AHPA, Press Room, Front Page, HP-Education, Webinars, Bookstore, Seminars

   
 

Event Details

Date: Tuesday, Dec. 13

Cost:
Members - $199
Non-Members - $499

Materials:
Webinar recording
Presenter slides
Presenter biographies

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.

This webinar will cover:

  • 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? And what is FDA looking for?
  • FDA “hot buttons” during inspections and what can be done to prepare and mitigate
  • Statistics and data compiled from FDA 483s
  • How to appropriately respond to a Form FDA 483 to head off a Warning Letter
  • Answers to your questions during the Q&A session

Presenters

  • Anthony L. Young, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP / AHPA General Counsel
  • Merle Zimmermann, Ph.D., Chief Information Analyst, AHPA
  • Jennifer M. Adams, Esq., Associate, Amin Talati & Upadhye

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Tags: cGMP

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