The ICH Q11 API Manufacturing Workshop 2018 is a seminar that covers topics such as:
- Process controls
- Manufacturing process development
- Control strategy
- Selection of starting materials
- Batch Records
- Standard Operating Procedures
- Submission of information (eCTD)
- Process validation evaluation
- ECTD
- Life cycle management
The ICH Q11 API Manufacturing Workshop 2018 brings together:
- Quality Control Teams
- Quality Assurance Teams
- Microbiologists
- Chemists
- Design Engineering Teams
- Process Engineering Teams
- Manufacturing Teams
- Process Automation Teams
- Validation Teams
- Operations Teams
- Regulatory Affairs Teams
- Utility Operations Teams
- Production Teams
