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Validity : 06th May'25 to 16th May'25
Medical Device Complaints & CAPA
- 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
Overview of the webinar
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.
Who should attend?
- Development Engineers
- Production Management
- QA/QC Personnel
- Software Developers
- Usability engineers
- Risk managers
- Design Engineering Managers
- Medical Device Engineering
- Quality Assurance
- Regulatory
- Management
Why should you attend?
Complaint handling and Corrective and Preventative Action (CAPA) are 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). Templates of the Complaint Evaluation form and the Corrective Action Plan handouts will be provided to the attendees.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 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.