Topics
- What is Closed-loop CAPA?
- U.S. FDA`s CAPA Expectations
- Failure Investigation Using an FI Template
- Correction, Corrective Action, Preventive Action
- Investigation Detail - Root or Probable Cause
- 7 Powerful Tools for Root Cause Analysis
- Effectiveness - Determining and Monitoring
- Impact - Often Neglected but of Major Importance
- Institutionalize vs. Entropy
Who should Attend
Attendees from companies in the medical device, diagnostic, pharmaceutical, and biologics fields:
- Regulatory affairs
- Senior management
- Production
- Quality assurance
- All personnel tasked with problem solving
- R&D and engineering
