Medical Device Engineering Change Control - 2017
- Start Date:
- Tuesday, 17 October, 2017
- End Date:
- Tuesday, 17 October, 2017 11:00am
- Health & Nutrition
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 ProcedurePre Release and Post Release Change ControlChange Transfer between Company and SuppliersForms and SOP's Who Will Benefit:Development EngineersProduction ManagementQA/ QC PersonnelEngineering ManagementRegulatory 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: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All