The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: October 18, 2018 from 1pm to 2pm
Street: 9106 Seven Locks Road
Website or Map: https://www.compliancetrainin…
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Oct 16
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.
Areas Covered in the Session :
CAPA phases to be discussed
Who Will Benefit:
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.
Edwin Waldbusser 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.