FDA Inspection Trends, cGMP Compliance Issues and Responding to an FDA 483

FDA Inspection Trends, cGMP Compliance Issues and Responding to an FDA 483

Two-part webinar will provide insights into recent cGMP inspection trends

Published: Monday, August 6, 2018

Event date: 12/4/2018 1:00 PM - 3:00 PM Export event

 

 

Event Details

Date: Dec. 4 and 18 , 2018

Time: 1:00-3:00 PM EST

Cost:
Members - $199
Non-Members - $399

Materials:
Webinar recording
Handouts
Presenter slides
Presenter biographies

This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that have been the primary focus of recent FDA inspections. This knowledge will assist business in better allocating and directing their compliance resources.

This two-part webinar will provide data on recent FDA inspections, an overview of emerging compliance issues and strategies for responding to an FDA 483 in order to avoid an FDA warning letter.

Part 1 – December 4

Veteran industry legal experts will provide an insider’s view of the current cGMP enforcement landscape and strategies for compliance. 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. Said analysis includes actual FDA 483 inspection reports, observation forms, and establishment inspection reports (EIRs). A summary of the collection process, a review of the data and detailed examples will also be provided.

A 30-minute Q&A session will follow the speaker presentations to answer specific questions about FDA inspections, enforcement actions, and related matters.

Part 2 – December 18

An extended Q&A session will address attendee questions. Legal experts will then provide strategies for companies to effectively respond to an FDA 483 in order to avoid getting a Warning Letter. Tips for conducting an FDA inspection will also be provided.

Topics

  • Own label distributors and contract manufacturers: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • FDA inspection practices and what should be done to prepare
  • Detailed analysis of recent FDA inspection reports
  • Effectively responding to an FDA 483 so as to avoid a Warning Letter
  • FDA inspection do’s and don’ts
  • Answers to your questions during the extended Q&A session

Presenters

  • Jay Manfre, Esq., Associate, Collins Gann McCloskey & Barry PLLC
  • Anthony L. Young, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP (Q&A Only)
  • Merle Zimmermann, Ph.D., Chief Information Analyst, American Herbal Products Association (AHPA)
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