Medical Device Engineering Change Control - 2017

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

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]