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
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
