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Medical Device Complaints & CAPA

Duration : 60 Minutes

Edwin Waldbusser, Medical Device

Ed 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, softwa Read more

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.

Course Objectives:

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).

Course Outline:

• 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

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Development Engineers
• Production Management
• QA/QC Personnel
• Software Developers
• Usability engineers
• Risk managers
• Design Engineering Managers
• Medical Device Engineering
• Quality Assurance
• Regulatory
• Management

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Medical Device Complaints & CAPA

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