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The Hitchhiker's Guide to 483s and Warning Letters

The Hitchhiker's Guide

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Duration: 120 Minutes
$288.00 Recorded Session
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$489.00 Training CD
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Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.

Objectives of the Presentation:
  • FDA Inspections - background
  • Causes of Form 483 / Warning Letter
  • Some recent results of companies failing to respond appropriately
  • Best Practices for Responding to 483
  • Best Practices for Responding to Warning Letter
  • What to do if the responses fail
Who can Benefit:
  • CEO
  • Regulatory VP
  • Quality VPs
  • IT VPs
  • Regulatory Affairs Professionals
  • Quality Managers
  • Quality Engineers
  • Small Business Owners
  • GxP
  • Consultants
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