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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