Curriculum
Course Description:
This course covers:
- Background on raw materials as a critical component of good manufacturing practices
- Types of raw materials
- Starting materials for biotechnology-based manufacturing
- Materials used during purification and downstream manufacturing
- Critical raw materials for analytical testing and assays used for release and stability testing
- Considerations for quality control of raw materials (compendial and non-compendial)
- Including case studies: (1) animal-derived raw materials, (2) leachables from containers or tubing raw materials
- Changes to raw materials used in a licensed product and examples of types of filings required based on potential impact to product quality
This recording features
a presentation by Ashutosh Rao.Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.