This management report from FDAnews shows you how to establish and maintain an effective CAPA system so you can pass your next inspection. In an easy-to-read format you’ll find guidance critical to avoiding FDA enforcement action, including:
Key cGMP requirements for drug, device and biologic manufacturers, and why solid CAPA systems are important to meeting them
Top CAPA violations cited by the FDA in 2004
Trends in FDA enforcement action related to CAPA
CAPA dos and don’ts
Tips on maintaining an effective system
Standard operating procedures to employ during the investigation of problems
Best sources and analysis of data to use in a CAPA investigation
A list of frequently asked questions and answers related to CAPA systems
Plus you'll get these time-saving resources —
Definitions of CAPA-related terminology
The FDA’s drug manufacturing compliance manual
The FDA’s guide to inspections of quality systems
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