Change Control according to GxP and GMP Requirements 2019 is a workshop dedicated to regulatory expectations from the FDA, EU and ICH perspective.
Change Control according to GxP and GMP Requirements 2019 covers topics such as:
- The required components of a thorough Change Control record
- Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records
- Elements of effective Change Control management:
Change Control according to GxP and GMP Requirements 2019 brings together:
- Documentation Department Management and Staff
- Quality Assurance Department Management and Staff
- Records Managers
- Manufacturing Department Management and Staff
- Compliance Department Management and Staff
- Document Control Management and Staff
- IT/Software Department Management and Staff
- Medical Affairs Management and Staff
- Laboratory Management and Staff
- Clinical Management and Staff
