Learning Objectives:

Upon completing this course, participants should be able to:

• Understand the purpose of change control
• Understand regulatory requirements and FDA expectations for change control
• Identify what types of changes are /are not subject to change control
• Properly describe changes
• Properly justify changes
• Develop a comprehensive Change Execution Plan
• Conduct a proper change Risk Assessment
• Ensure proper execution of changes
• Ensure proper implementation of changes
• Develop a complete Change Control documentation package
• Utilize critical thinking skills throughout the change control process
• Avoid pitfalls during the change control process