Webinar: Preparing for FDA cGMP Facility Inspections

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Webinar: Preparing for FDA cGMP Facility Inspections

Recorded December 17, 2019

Published: Tuesday, December 17, 2019

 

Event Details

Date: Dec. 17, 2019

Time: 1-3pm EDT

Cost:

  • Members - $199
    • $298 for both Dec. webinars
  • Non-Members - $399
    • $698 for both Dec. webinars

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 businesses in better allocating and directing their compliance resources. 

Industry experts discuss recent FDA inspections, provide an overview of emerging compliance issues and strategies for responding to an FDA 483 in order to avoid an FDA warning letter. A veteran industry legal expert provides 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. This includes data compiled from FDA 483 inspection reports, observation forms, and establishment inspection reports (EIRs). Strategies for companies to effectively respond to an FDA 483 in order to avoid getting a warning letter will be offered, and tips for conducting an FDA inspection are also 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

A 20-30-minute Q&A session follows the speaker presentations to answer attendees' specific questions. Submit your questions before the live event via email to Natasha Weaver.

Presenters

  • Marian Boardley, Owner, Marian Boardley Consulting LLC 
  • Will Woodlee, Esq., Partner, Kleinfeld, Kaplan & Becker LLP & AHPA General Counsel
  • Merle Zimmermann, Ph.D., Chief Information Analyst, American Herbal Products Association (AHPA)

Materials

  • Webinar recording
  • Presenter slides
  • cGMP compliance resources
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