Hardware Podcasts

#388: Elements of an Effective CAPA Program

Global Medical Device Podcast · 24 Oct 2024 · 38m · Episode 388

What this episode covers

Georg Digel, a CAPA expert with over a decade of experience in medtech, explains how to build an effective Corrective and Preventive Action (CAPA) program that drives real improvement rather than just compliance. He details the critical steps of defining triggers, executing root cause analysis, and distinguishing between containment, correction, and corrective actions using a manufacturing example. The conversation emphasizes the importance of Verification of Effectiveness (VoE) and negative impact assessments to ensure solutions are safe and sustainable. Digel warns against 'death by CAPA' by flooding systems with trivial issues, advocating for a focus on high-risk and systemic problems to protect patient safety.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, RookQS, Johnson and Johnson, FDA
Also
ISO 13485, ISO 9001

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