Key takeaways
Understand
- How to apply ASA to predict your product stability
- How to improve the stability by picking the right excipient
- Degradation of biologics by chemical, physical and microbiological factors
- Bracketing and matrixing to improve your product stability
Learn
- About guidance and expectations for product stability protocol
- To identify proper analytical methods for stability assessment
- How to find the correct packaging for biologics with low stability
- About acceptation of reduced stability data for new formulations
Gain
- A comprehensive overview on stability and shelf-life regulatory landscape
- Harmonized ICH stability guidelines: Q1a-F and Q5C
- Requirements for stability testing in Climatic Zones i-iV
- A contact with key leaders and regulatory authority to build up your network
Training Features
- Interactive way through stimulation of discussions and giving the participants an opportunity to advance their ideas.
- Individual case by case consultancy with the trainers
- All delegates will receive comprehensive course documentation
- Certificate of Completion issued by the Trainers
- 5H+ of networking with other industry experts
- Case studies from the trainer’s experience
