Engineering Control Change in Medical Devices

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.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Production Departments
• Development Engineers

Course Director: Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.