A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.
Areas Covered in the Session: - QSR and ISO 13485 requirements for CAPA
- Elements of a cross-procedural CAPA program
- Applications of CAPA
- CAPA data and its uses
- Application of risk management to CAPA program
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- R&D management
- Regulatory management
- QA management
- Consultants
- Quality system auditors
