TicketForEvent uses cookies to operate. By continuing to use the site, you agree that cookies are being collected, changed and stored on your device. You can change cookie preferences in your browser's settings. OK
Ticket sales have ended on 18 October 2018 12:00 | ||||
Continue » |
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). |
Areas Covered in the Session : CAPA phases to be discussed
|
Who Will Benefit:
|
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. Event URL: https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00115
Organizer: Compliance Training Panel Website: www.compliancetrainingpanel.com/Webinar/Live Email: support@compliancetrainingpanel.com Phone: 844-216-5230 |
Organizer: Compliance Training Panel
Website: www.compliancetrainingpanel.com/Webinar/Live