The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition


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Since the 2007 publication of the second edition, there have been substantial changes in medical device technology, medical device regulatory approaches, and FDA and international guidances and standards. This new third edition has been developed to provide accurate and useful information to the medical device community, updated to reflect the current status of the many rapidly evolving areas of the medical device environment.

The content has been reviewed by a team of FDA and AAMI reviewers, and the focus has been on adding new regulations, standards, and guidances; updating inactive or out-of date references; and increasing readibility in the layout.
Major updates include:

  • Text of the revised 21 CFR Part 820 regulation, incorporating Unique Device Identification
  • Changes in FDA organization and regulatory strategies
  • The most current information on Process Validation, Combination Products, Software Validation, and Risk Management
  • New comprehensive chapters on Personalized Medicine/Companion Diagnostic Devices, FDA Medical Device Classification, and Premarket Submissions
  • Expanded appendices with abbreviations, acronymns, and bibliography
  • Greatly expanded list of online references
  • Updated index

Jack Ward, Technical Editor with contributions from FDA and Industry

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