The Guide to CAPA and Root Cause Analysis in FDA-regulated Industries
By Larry Stevens, Brian Dense
Published in: The FDA Group
Published on: November 18, 2022
What you'll find inside:
- Root cause analysis and CAPA basics
- Strategies for overcoming common challenges such as defining your CAPA process or determining when CAPA is appropriate
- CAPA's connection to other parts of your QMS
- Practical perspectives on shifting to a prevention mindset
- Firsthand experiences from a former FDA official
- How third-party specialists can play a vital role in remediation projects.
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