Webinar: Preparing for FDA cGMP Facility Inspections

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Webinar: Preparing for FDA cGMP Facility Inspections

Recent trends in FDA cGMP inspections

Published: Tuesday, November 5, 2019

Event date: 12/17/2019 1:00 PM - 3:00 PM Export event

 

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. 

During this event, data will be presented on recent FDA inspections, and an overview of emerging compliance issues and strategies for responding to an FDA 483 in order to avoid an FDA warning letter will be provided. A veteran industry legal expert 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. 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 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

A 20-30-minute Q&A session will follow 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., Information Analyst, American Herbal Products Association (AHPA)

Materials

  • Presenter slides
  • Presenter biographies
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