Change Control Best Practices - Avoiding Unintended Consequences of Changes is a seminar that covers topics such as:
- 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
Change Control Best Practices - Avoiding Unintended Consequences of Changes brings together:
- Reviewers / approvers of change controls
- Change proposal authors
- Production staff / management
- Change control system owners
- Validation staff /management
- Engineering staff / management
- Regulatory affairs staff / management
- QA and QC staff / management