2021 - Change Control Best Practices - Avoiding Unintended Consequences of Changes

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