Handling Medical Device Complaints & CAPA

Learn how to manage the Complaint handling and Corrective and Preventative Action (CAPA) process effectively with our informative webinar. We cover the entire CAPA process, from information gathering to MDR and Recall decision-making to final CAPA closing, including required post-closing effectiveness evaluation. Our course also addresses often-neglected Preventative Action and post-distribution product monitoring, including customer surveys. We discuss the integration of manufacturing non-conformities with the CAPA program and provide templates of the Complaint Evaluation form and the Corrective Action Plan handouts for attendees. As two of the most crucial areas for ensuring medical device safety and efficacy, Complaint handling and CAPA are among the top five areas where the FDA finds problems during inspections and issues 483s. It is crucial for medical device developers to have a strong understanding of the complicated Complaint and CAPA process and strike a balance between too many and too few CAPAs.

Areas Covered in the Session :

• 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

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

Course Director: Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed 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.