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This management report includes an expert analysis of real-life warning letters and a step-by-step guide to what the FDA looks for when it inspects your CAPA system. Plus, you’ll get a list of best practices to make sure your system can stand up to the agency’s scrutiny. Also included is an appendix that contains the full text of the FDA’s own Compliance Program Guidance Manual and Guide to Inspections of Quality Systems.
Tune Up Your CAPA System: A Practical Guide is a must for anyone responsible for keeping their medical device or pharmaceutical company from getting cited by the FDA in a warning letter or Form 483, including:
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