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

Topics

• 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

Who should Attend

• Quality Assurance
• Operations
• Validation
• Regulatory Affairs