Topics
- FDA Quality System Requirements for RCA
- Principles of Root Cause Analysis (RCA)
- Root Cause Analysis methods
- RCA from the point of view of the system
- Using Fault Tree Analysis as RCA tool
- Role of RCA in Failure Mode and Effects Analysis
- Risk reduction based on RCA
- Risk analysis based on RCA
Who should Attend
Attendees from Medical Device companies/ manufacturing sites including Product Management, Design engineers, Safety, Production management, Purchasing & Production, Regulatory, Suppliers and Quality Assurance staff.
