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. 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.

Why should you Attend

FDA and ISO require 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.

Areas Covered in the Session

• Why change control Change control procedure  Pre release and post release change control Evaluating impacts on WIP, tooling,etc.
• 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