Medical Device Complaints and Corrective and Preventative Action (CAPA)
Edwin Waldbusser is a consultant retired from the industry after 20 years in management of the development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 9 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is striking a balance between too many CAPA’s (strangles the system) and too few (problem areas escape fixing).
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post-closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be discussed. Post distribution product monitoring including customer surveys will be explained. Integration of manufacturing non-conformities with the CAPA program will be discussed.
- Sources of information (complaints)
- Information gathering & proactive information gathering
- Information evaluation (is it a Complaint, is it a CAPA, should it be investigated)
- Risk analysis applied to CAPA
- Root cause determination
- CAPA Investigation Report & CAPA action Plan
- Verification/Validation of CAPA action
- Post-closing effectiveness check
- CAPA program metrics
Why Should You Attend
After this course, you will be able to construct and maintain a strong but manageable Complaint/ CAPA system that will satisfy FDA requirements.
Templates of the Complaint Evaluation form and the Corrective Action Plan will be handouts.