GMP Compliance Chapter - Change Control, Out-of Specification Investigations and CAPA 2013 is a course that covers topics such as:
- Optimizing Change Control Program
- Regulatory Requirements of Change Control
- Evaluation of the Change Proposal
- Planning and the Initiation of a Change Proposal
- Change Control Documentation Requirements
- Change Control Implementation
- Developing an effective change control form
- Developing a Harmonized Change Control Procedure
- Benefits for having Establishing a Robust Change Control Program
- Post Implementation — Monitoring and Maintaining a Change Control Program
GMP Compliance Chapter - Change Control, Out-of Specification Investigations and CAPA 2013 brings together:
- Change Control
- QA/QC
- Validation
- Manufacturing/Production
- Production Engineering
- Regulatory Affairs
- Validation
- GMP Compliance
- Lab Operations
- Process Development
- Suppliers
- Consultants