This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.
This webinar will demonstrate to attendees how best to create stability protocols for drug substance and drug product, including long term stability; accelerated stability and special stability studies (e.g., light or oxygen sensibility).
- Creating stability protocols
- Shipping protocols
- ICH and FDA specific requirements
- Updating the FDA with data during development and commercial phases
- Changing expiry dating with more data
- Manufacturing Departments
- Supply Chain Departments
- Technical Operations Departments
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments