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.