Managing CAPA Systems

August 2005
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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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