May 4, 2007 | Ken Reed

Meeting FDA Expectations for Corrective Action Programs

In your company, is retraining the employee the frequent answer to Corrective and Preventive Actions (CAPA)? Are CAPAs often viewed as an afterthought to conducting Root Cause Analysis (RCA)?

Summit attendees learned what the FDA expects from the Biological Pharmaceutical (Bio Pharma) industry in the area of CAPAs. In Lisa Smith’s Summit presentation, an example of an adequate CAPA versus a robust CAPA was discussed and the benefits of each was compared.

Attendees learned about:

FDA requirements

Criteria for effective CAPAs

The difference between adequate versus robust CAPAs

The concept of mistake-proofed CAPAs

The importance of using cross-functional improvement teams to solve nagging problems systemically

The importance of assessing the post-implementation effectiveness of CAPAs

Click the link below to download a copy of Lisa’s presentation.


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