Speaker Profile


Edwin Waldbusser

M.B.A

Ed 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/ non-conforming product programs.

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.
How to prepare for and host a FDA inspection and respond to 483’s
How to prepare for and host a FDA inspection and respond to 483’s

Speaker:Edwin Waldbusser
Time: 14th December 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90197

Thu
14
Dec 2017

Human Factors and Usability Studies following ISO 62366 and the new FDA Guidance
Human Factors and Usability Studies following ISO 62366 and the new FDA Guidance

Speaker:Edwin Waldbusser
Time: 21st December 2017 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90202

Thu
21
Dec 2017

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