How to Develop, Implement and Manage an Effective Change Control Program 2019 is a webinar that covers topics such as:
- All Elements of a Change Control Record
- Ensure changes do not negatively impact the business or established marketing authorization
- The importance of utilizing Subject Matter Experts from multiple functional areas to ensure proper evaluation, approval and implementation of proposed changes
- Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
- How to incorporate a Quality risk-based approach to evaluating proposed changes
- What steps should be taken post implementation to confirm the objectives were achieved
- Regulatory Guidance Review
- EU (EurdraLex)
- FDA (CFR)
- ICH Q10
How to Develop, Implement and Manage an Effective Change Control Program 2019 is intended for:
- Quality Assurance
- Operations
- Validation
- Regulatory Affairs
