Change Control Best Practices: Proposals and Execution 2015

Topics

• What/why Change Control?
• Overview of Change Control regulatory requirements
• Change Proposal
• Types of changes subject to Change Control
• Approval to execute change
• Change Assessment (Risk, Impact)
• Implementing the change
• Executing the change
• Change Control Documentation

Who should Attend

Attendees from:

• Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
• Change Control Authors (e.g. Manufacturing, Quality Control, Engineering, Facilities, R & D, Supply Chain Management, etc.)
• Quality Assurance Quality Assurance/Management personnel with ownership of Change Control Systems
• Management of Functional Areas Required to Perform Physical Changes/Document Changes