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".