Why Should You Attend:
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur.
At the completion of this course, attendees will be able to:
- Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records.
- Understand all the required components of a thorough Change Control record.
- Understand all the elements of effective Change Control management:
- How to develop a cross-functional team 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
Agenda
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
Who Should Attend
- Operations
- Quality Assurance
- Regulatory Affairs
- Validation
