Writing CAPAs The Right Way

An FDAnews FREE Webinar • Sponsored by ComplianceQuest
Tuesday, Nov. 29, 2022 • 1:30 PM - 2:00 PM EST

Even if you are following best practices when implementing CAPAs, they might not be as effective as you’d like them to be if you are not writing them correctly. Effective CAPA implementation needs effective problem communication with team members, clear description of actions and clear goals.

This Advanced Compliance Writing Webinar will teach you how to draft corrective and preventative actions in a manner that will enable proper emphasis and guarantee the effectiveness of these actions. Join us as we discuss how to write (or...put pen to paper) in a manner that both communicates the problem and ensures effective CAPA implementation. Do not miss the chance to learn from real examples and discover dangerous language you might be using that threaten your CAPA process.

Learn How to propose Effective Corrective and Preventive Actions:

  • Communicate corrective actions in a manner to ensure compliance
  • Outline typical CAPA writing problems
  • Steps to follow to structure effective CAPA’s
  • Understand the Do’s and Don’ts

Compliance Writing Examples:

  • Delineate what is missing in a CAPA
  • What would a successful CAPA look like

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.