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 conformaties with the CAPA program will be discussed.

CAPA phases to be discussed

1. Sources of information (complaints)
2. Information gathering & proactive information gathering
3. Information evaluation (is it a Complaint, is it a CAPA, should it be investigated)
4. Risk analysis applied to CAPA
5. Root cause determination
6. CAPA Investigation Report & CAPA action Plan
7. Verification/ Validation of CAPA action
8. Post closing effectiveness check
9. CAPA program metrics

1. Medical device engineering
2. Regulatory
3. Quality Assurance
4. Management

Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

Edwin Waldbusser has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.