Medical Device Complaints & CAPA


Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 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. He now consults internationally 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. Mechanic........

Overview

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 should you attend this webinar?

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

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHCEM003

Training Options:

Duration: 60 mins

 View anytime

 Recorded: [Six month unlimited access]

 $237 (Single Attendee)  $599 (Unlimited Attendee)

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