FREE ON-DEMAND WEBINAR 10th Mar, 2025 9:00 AM - 9:45 AM CST

How to Prevent Weak CAPA Investigations

How to Prevent Weak CAPA Investigations

Did you know that in the last 5 years, Corrective and Preventive Action (CAPA) remains one of the top areas cited by the FDA in 483 Observations in the area of Medical Devices?

On Monday, 10th March 2025, Comply Guru’s Michelle Keane will be joined by Jackie Torfin, CEO and Principal Advisor with QLear Advisors to share expert insights on how to prevent weak CAPA investigations.

Jackie is CEO and Principal Advisor at QLeaR Advisors, a consulting firm focused on quality and regulatory compliance for MedTech and Biotech companies.  She supports start-ups and emerging clients in understanding and being compliant to the maze of regulations.

This Webinar will discuss key topics including:

  1. Risk-Based CAPA for Prevention
  2. ISO 13485 CAPA Strategies
  3. Effective Problem Definition
  4. CAPA Driven Preventive Actions
  5. Q&A

Register for FREE to join this Webinar. Please note that registration is required to join this free live event.

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Michelle has a proven track record with more than 20 years’ experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.

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