Medical Device Complaints & CAPA, Online
18-10-2018
Description : 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.
Why :
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).
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
How using the same logic as the auditors can help you be in a state of constant readiness.
Areas Covered in the Session :
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 Who Will Benefit: 1. Medical device engineering 2. Regulatory 3. Quality Assurance 4. Management About Speaker:
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.
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