Program Agenda:
8:30 – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 - 10:30 AM Understanding CAPA :
Review of Regulations
Definitions
Where/When is CAPA Required
10:30 - 10:45 AM Tea/Coffee Break
10:45 - 12:15 PM Elements of a Corrective Action Program :
Essential SOPs and Other Documentation
Detection of nonconformance
Identification of cause (Investigation)
Review of Investigation
Determination of Corrective/Preventive Action
Performance of Corrective Action
Implementation of Corrective Action
Effectiveness of Corrective Action
Common Misconceptions
12:15 - 01:15 PM Lunch
01:15 - 02:45 PM Root Cause Analysis
Sources of, and Application of, CAPA
02:45 - 03:00 PM PM Break
03:00 - 04:45 PM How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods
Fun and Games with CAPA: A Mini-Workshop
04:45 - 05:00 PM Q&A – Conclusion
8:30 – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 - 10:30 AM Understanding CAPA :
Review of Regulations
Definitions
Where/When is CAPA Required
10:30 - 10:45 AM Tea/Coffee Break
10:45 - 12:15 PM Elements of a Corrective Action Program :
Essential SOPs and Other Documentation
Detection of nonconformance
Identification of cause (Investigation)
Review of Investigation
Determination of Corrective/Preventive Action
Performance of Corrective Action
Implementation of Corrective Action
Effectiveness of Corrective Action
Common Misconceptions
12:15 - 01:15 PM Lunch
01:15 - 02:45 PM Root Cause Analysis
Sources of, and Application of, CAPA
02:45 - 03:00 PM PM Break
03:00 - 04:45 PM How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods
Fun and Games with CAPA: A Mini-Workshop
04:45 - 05:00 PM Q&A – Conclusion
