Engineering Change Control in Medical Device Environment

Overview:

Change control focuses on managing changes throughout a product’s life cycle as a part of current good manufacturing practices. Extensive regulations ensure that changes don’t put the safety, reliability and performance of products at risk. Therefore, it’s critical that medical device manufacturers adhere to all of the regulatory change control guidelines.

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 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.

Learning Objectives:

• The stages of the engineering change process
• Issue identification & scoping
• Engineering change request creation
• Engineering change request review
• Engineering change order Creation
• Engineering change order review
• Engineering change notification/notice (ECN)
• Change implementation
• Engineering change order benefits
• Pre release and post release change control
• Change transfer between company and suppliers.

Areas covered in the session:

• What is an engineering change order?
• Change control procedure
• Pre release and post release change control
• Change transfer between company and suppliers\
• Forms and SOP's.

Why should you attend?

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.

Who will benefit?

• Development Engineers
• Production Management
• QA/ QC personnel
• Engineering management
• Regulatory personnel

Presenter Bio:

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 11 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.

Note:

Live attendees will receive a WebEx meeting invitation upon successfully completing the registration.

Participants who have opted for recorded version of the program will receive a WebEx link within 8 hours after completion of the event, using the link participants can view/download the event at anytime of their convenience.