Successful Change Control Management 2019

Topics

• What is Change Control?/Why Change Control?
• Overview of Change Control Regulatory Requirements
• Like for Like
• Types of Changes Subject to Change Control
• Facility Changes
• Specification changes
• Emergency Changes
• Equipment Changes
• Proper documentation
• Change Control Proposal
• Change Assessment (Risk, Impact) and Approval to Execute
• Elements to be included
• Impact to facility
• Impact to products
• Change Control Board Development
• Impact to Regulatory Filings
• Establishing Action Items
• Areas of Responsibilities for Board Members
• Final Implementation of Change
• Establishing Deadlines
• Effectiveness of the change
• How to close out a change
• Hard copy systems
• Change Control Documentation
• Electronic systems

Who should Attend

• Quality Control Teams
• Quality Assurance Teams
• Production Teams
• Manufacturing Teams
• Management Teams
• Regulatory Teams