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
- Like for Like
- Specification changes
- Facility Changes
- Equipment Changes
- Emergency Changes
- Change Control Proposal
- Proper documentation
- Elements to be included
- Change Assessment (Risk, Impact) and Approval to Execute
- Impact to products
- Impact to facility
- Impact to Regulatory Filings
- Change Control Board Development
- Areas of Responsibilities for Board Members
- Establishing Action Items
- Establishing Deadlines
- Final Implementation of Change
- How to close out a change
- Effectiveness of the change
- Change Control Documentation
- Hard copy systems
- Electronic systems
Who Should Attend:
- Quality Assurance Teams
- Quality Control Teams
- Manufacturing Teams
- Production Teams
- Regulatory Teams
- Management Teams