Knowledge is Power: The Most Common Causes of 483s

This presentation will discuss common 483s, and how to prevent them, including:

  • Lack of or inadequate CAPA procedures - 400
  • Lack of or inadequate complaint procedures - 269
  • Lack of or inadequate procedures involving purchasing controls - 138
  • Lack of or inadequate process validation - 137
  • Lack of written MDR (Medical Device Reporting) procedures - 127
  • Nonconforming product, procedures not adequately established - 127
  • CAPA activities or results not adequately documented - 115

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