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 Conduct a Human Factors/ Usability Validation
How to Conduct a Human Factors/ Usability Validation

Speaker:Edwin Waldbusser
Time: 17th April 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90287

Tue
17
Apr 2018

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: 29th January 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90197

Mon
29
Jan 2018

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:75 Minutes
Model : GRC-90202

Thu
21
Dec 2017

Qualification of contract manufacturer organizations based on practical experience
Qualification of contract manufacturer organizations based on practical experience

Speaker:Edwin Waldbusser
Time: 24th April 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90294

Tue
24
Apr 2018

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