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. This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.
Learning Objectives:
- 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
- Understand what steps should be taken post implementation to confirm the objectives were achieved
Who Should Attend
- Quality Assurance Department Management and Staff
- Documentation Department Management and Staff
- Manufacturing Department Management and Staff
- Records Managers
- Document Control Management and Staff
- Compliance Department Management and Staff
- Medical Affairs Management and Staff
- IT/Software Department Management and Staff
- Clinical Management and Staff
- Laboratory Management and Staff