This webinar will discuss how to design an effective change control system - electronic as well as paper-based - with traceability and closed loop verification built into the process.
This webinar will provide attendees with guidance on how to design and implement an efficient closed loop change control system.
Key elements of a closed loop change control system.
Inputs that drive change control and traceability.
Closing the loop around contract developers and manufacturers.
Paper vs. Electronic; advantages and pitfalls.
The myth of ‘the simple change’.
Roles and responsibilities in change control.
What auditors look for in change control?
Why Should You Attend:
Understanding your requirements for your company's change control system and planning the implementation will help you to avoid unnecessary changes due to gaps discovered later in the implementation process. This becomes even more critical when adding additional layers of communication due to outsourcing. As with any development effort, the starting point is a comprehensive set of requirements. Developing your company specific requirements for how changes are proposed, implemented and closed will reduce the risk of changes to the process later on.This webinar will provide attendees with guidance on how to design and implement an efficient closed loop change control system.
Areas Covered in the Webinar:
Is it ever too early for change control?Key elements of a closed loop change control system.
Inputs that drive change control and traceability.
Closing the loop around contract developers and manufacturers.
Paper vs. Electronic; advantages and pitfalls.
The myth of ‘the simple change’.
Roles and responsibilities in change control.
What auditors look for in change control?
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:- Quality Assurance
- Documentation Control
- Engineering Management
- R&D Management
- Manufacturing and Supply Chain
- Regulatory Compliance Associates and Managers
Course Provider
Michael Kagan,
