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FDA Expectations for CAPA: Strategies for Compliance

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September 2006
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Are You Overlooking "Hidden" CAPA Issues?
Don't Risk a Warning: Build the Proper CAPA Program Today

The most complex corrective and preventive action (CAPA) issues are often found outside the routine channels you may already be using to assess and track CAPAs.

Make sure you take all the issues into account based on industry guidances — and uncover tough-to-spot problems, before they trigger an FDA warning letter.

In one single, easy-access resource, FDA Expectations for CAPA: Strategies for Compliance allows you to:

  • Decipher current regulatory requirements for CAPA — for drugs, devices, GLPs and GCPs
  • Harness the key elements of an effective CAPA system for your own program
  • Discover the elements of a good investigation
  • Stay up to date on trending requirements, including:
    • Feedback sources
    • What and when to trend
    • Statistical techniques requirement
    • Statistical methodologies
    • Management reviews
  • Confidently pick-and-choose CAPA tools, including what to look for in computerized tools
  • Grasp the main objectives of failure investigations and root cause analysis
  • And other action-based strategies

Includes CFRs and the FDA's Final Report on cGMPs for the 21st Century

Moreover, FDA Expectations for CAPA: Strategies for Compliance gives you time-saving access to:

  • The FDA's final report on Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century
  • Answers to frequently asked CAPA questions
  • Four separate appendices on the Code of Federal Regulations (21 CFR)

In this latest management report from FDAnews you'll have:

  • Step-by-step basics on how to build your own comprehensive CAPA program
  • Access to a complete discussion of regulatory expectations
  • The real benefits of an effective CAPA system
  • And more

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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