Boston Professional Events List


Medical Device Engineering Change Control - 2017


Date
Oct 17, 2017 - 10:00 AM
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
Netzealous LLC DBA - Compliance4All,

Fremont,
CA,
US,
ZIP: 94539
Phone: 18004479407

Ticket Price: $ 150.00
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]

Event Categories
Keywords: Health , HealthCare , medica




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