Webinar On "Engineering Change Control for Medical Devices"

Webinar On "Engineering Change Control for Medical Devices"

Mar 15 1:00pm - Mar 15 2:00pm @ Online, Bethesda
Conference
Description :
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
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 years of practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time cons...
Description :
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
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 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 :

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

About Speaker:
Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.
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Organizers