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Medical Device Engineering Change Control - 2017

 
  August 09, 2017  
     
 
Netzealous LLC DBA - Compliance4All, Online
2017-10-17


Overview:  
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.

Why should you Attend:
FDA and ISO call for change control but do not provide any further guidance 

as to how to create a compliant system. The situation gets complicated when 

a company has suppliers or contract manufacturers and changes and 

approvals must pass from one to the other. 

Areas Covered in the Session:
Change Control Procedure
Pre Release and Post Release Change Control
Change Transfer between Company and Suppliers
Forms and SOP's

Who Will Benefit:
Development Engineers
Production Management
QA/ QC Personnel
Engineering Management
Regulatory Personnel



Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
 
 
Organized by: Event Manager
Invited Speakers:
Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in 

management of development of medical devices (5 patents). He has been 

consulting in the US and internationally in the areas of design control, risk 

analysis and software validation for the past 8 years. Mr. Waldbusser has a BS 

in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 

9000 Lead Auditor and a member of the Thomson Reuters Expert Witness 

network.
 
Deadline for Abstracts: 2017-10-16
 
Registration:
Full Details & Registration Link:
 
E-mail: support@compliance4All.com
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