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Engineering Change Control for Medical Devices

  March 12, 2018  

Edwin Waldbusser, USA

Description :

This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract manufacturers will be explained. Change control forms will be provided and described in detail. 

Organized by: Compliance Training Panel
Invited Speakers:

Edwin Waldbusser

 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.;
Deadline for Abstracts: 2018-03-15
Thursday, March 15, 2018 
EST 13:00
Duration : 60 Minutes
E-mail: support@compliancetrainingpanel.com
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