Medical Device - Engineering Change Control
WebcastFaculty
OVERVIEW
Medical Device - Engineering Change Control is organized by OnlineCompliancePanel and would be held on Jun 21, 2017.
The target audience for this medical event for Development Engineers, Production Management, Engineering management, Regulatory personnel, Quality Control personnel, Quality assurance personnel, Research and Development, Software, Maintenance, Process Design and Development.
Conference Objectives are :
• 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 this Webinar :
• What is an engineering change order?
• Where does an ECO fit in the engineering change management process?
• Change control procedure
• Pre release and post release change control
• Change transfer between company and suppliers
• Forms and SOP's.
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.
Additional details will be posted as soon as they are available.
The target audience for this medical event for Development Engineers, Production Management, Engineering management, Regulatory personnel, Quality Control personnel, Quality assurance personnel, Research and Development, Software, Maintenance, Process Design and Development.
Conference Objectives are :
• 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 this Webinar :
• What is an engineering change order?
• Where does an ECO fit in the engineering change management process?
• Change control procedure
• Pre release and post release change control
• Change transfer between company and suppliers
• Forms and SOP's.
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.
Additional details will be posted as soon as they are available.
SPECIALITIES
Healthcare Technology
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