Change Control systems is an integral part of the quality management system (QMS) of each company. Their task and aim is to ensure that all announced or requested changes are carefully checked and completely documented and authorized.
Before starting implementing the change, one should know the importance :
- How is the change classified?
- Is it a variation or a change?
- Who needs to be informed?
- What are the regulatory consequences?
A sound Change Control system is used to manage changes of all types. The Change Control process is necessary to prevent inappropriate changes from occurring. All GMP-relevant changes should only be made with a complete review and approval of a quality function and any other department that might be impacted by the Change.
Areas Covered in the Session :
- Overview of Change Control Regulatory Requirements
- What is Change Control? / Why Change Control?
- Types of Changes Subject to Change Control
- Change Proposal
- Change Assessment (Risk, Impact)
- Approval to Execute Change
- Executing the Change
- Final Implementation of Change
- Change Control Documentation
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Engineering Departments
- Production Departments
- Operations Departments
- Regulatory Affairs Departments
- Validation Departments
- Documentation Departments
- Research and Development Departments
- Everyone who Reviews or Approves Change Control