2019 - How to Develop, Implement and Manage an Effective Change Control Program

Topic 1: Regulatory Guidance Review
FDA (CFR)
EU (EurdraLex)
ICH Q10
Topic 2: Review all Elements of a Change Control Record
Discuss the importance of utilizing Subject Matter Experts from multiple functional areas to ensure proper evaluation, approval and implementation of proposed changes.
Ensure changes do not negatively impact the business or established marketing authorization.
How to incorporate a Quality risk-based approach to evaluating proposed changes
Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
Understand what steps should be taken post implementation to confirm the objectives were achieved