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)