Advanced Compliance Writing CAPA
Mastering Failure Investigation and Root Cause Analysis

An FDAnews FREE Webinar • Sponsored by ComplianceQuest
Wednesday, Feb. 15, 2023 • 2:00 PM - 2:30 PM EST

CAPAs are an integral part of any continuous improvement system. So, if you don’t want your processes to become stagnant and risk falling behind innovative technologies and your competitors, you need a fool proof CAPA process.

Half of the effectiveness of your CAPA depends on how well you write it. In this advanced compliance writing webinar, you will learn how to ensure that your corrective and preventive action plans are valid. Discover the key adjustments you need to apply to your failure investigation techniques and root cause analysis to ensure your CAPAs are effective in preventing recurring issues.

Take-Aways

  • What’s the difference between root cause analysis and failure investigation
  • How to plan for a systematic investigation of discrepancies to prevent reoccurrence
  • The blueprint for expert root cause analysis
  • Failure investigation pitfalls with FDA Warning Letter review
  • Root cause analysis shortcomings with FDA Warning Letter review
  • Hands on compliance investigation/root cause analysis writing exercises
  • Avoiding dangerous root cause language

Who Will Benefit

  • Quality affairs
  • Regulatory affairs
  • IT

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Meet Your Presenter

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Judith Meritz

Life Sciences Regulatory Consultant
Meritz & Muenz LLP

Judith Meritz has more than 30 years of experience representing pharma and medical device companies. She specializes in strategic planning and compliance mediation concerning the FDA and other international regulatory agencies. She has held key regulatory and legal positions for companies including Medtronic, Covidien, Henry Schein and the American Red Cross. She chaired the medical device practice at two Washington DC law firms. She has been the key player in interactions with the FDA and drafted inspection responses to numerous FDA 483’s and warning letters. She has led companies to achieve successful outcomes and avoid further enforcement actions. She taught at the FDA CDRH college on inspection readiness and adverse event corrective actions.