Topics
- FDA QSR
- Regulatory Requirements
- Elements of a cross-procedural CAPA program
- ISO 13485
- CAPA Data, and best practices for its use
- Applications of CAPA
- Application of risk management to CAPA program
Who should Attend
Attendees from the medical device, diagnostic, pharmaceutical, and biologics fields:
- CAPA coordinator
- QA management
- Executive management
- Regulatory Affairs management
- Quality system auditors
- Consultants
