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.
Why Should You Attend:
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).Areas Covered in the Webinar:
- 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
Who Will Benefit:
- Manufacturing
- Supply chain
- Technical operations
- Quality control
- Quality assurance
- Regulatory affairs
Course Provider
Peggy Berry,
