Engineering Change Control Conforming to FDA regulations
  • CODE : EDWA-0042
  • Duration : 60 Minutes
  • Level : Advance
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Edwin Waldbusser is a consultant retired from the industry after 20 years in management of the 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 9 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.

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 differences 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.

Learning Objectives

  • Change control procedure
  • Pre-release and post-release change control
  • Change transfer between company and suppliers
  • Forms and SOP’s

Course Level - Basic to Advanced

Who Should Attend   

  • Development Engineers
  • Production Management
  • QA/ QC Personnel
  • Engineering Management
  • Regulatory Personnel

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. This webinar will describe a system, based on the regulations and years of practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time-consuming. Change control forms will be provided and explained.

  • $179.00



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