CAPA - What does the FDA expect from Medical Devices Manufacturers?

Deficiencies with regard to CAPA (Corrective and Preventive Action) are regularly Top 1 in FDA's Warning Letter statistics (see our GMP News from 23 September 2014). The FDA has just recently published presentations in form of webinars on the following topics:

  • Investigational Device Exemption (IDE) Program
  • 510(k) Program
  • Corrective and Preventive Actions (CAPA)
  • Electronic Medical Device Reporting (eMDR)

The 31 slides on CAPA are particularly interesting and aim to:

  • Explain the objective of CAPA
  • Differentiate individual terms like Correction, Corrective Action, Preventive Action
  • Clarify the requirements from the Quality System Regulations 21 CFR 820 (GMP for Medical Devices)
  • Present diverse "Tools"

and

  • Show examples and "Best Practices"

There is even the possibility to have a look at the webinar's slides "Corrective and Preventive Action Basics".

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GMP Conferences by Topics

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