Zion Herbals

FDA Inspections, Warning Letters & Emerging cGMP Compliance Issues

http://myemail.constantcontact.com/AHPA-Update–Final-reminder-for-webinar-on-recent-trends-in-FDA-cGMP-inspections.html?soid=1101334774265&aid=Uk51pEUAqe8

An insider’s view of the current cGMP enforcement landscape


Event Details

 
Date: Tuesday, Dec. 13
 
Time: 1:00-3:00 PM EST
 
Cost:
Members – $199
Non-Members – $499
 
Materials:
Webinar recording
Presenter slides
Presenter biographies
This webinar is designed to help 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 will provide attendees with an insider’s view of the current cGMP enforcement landscape. AHPA staff will 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 will also be provided.
A 20-30-minute Q&A session will follow the speaker presentations to answer specific questions about FDA inspections, enforcement actions, and related matters.
Topics

  • Click here to submit questions anonymously BEFORE the webinar so that presenters can address YOUR ISSUES during their presentation
  • 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 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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