Application of Quality by Design Principles during Process Development and Scale-Up
Scale-Up and Process validation
Practical approaches for Scale-Up of the Wet and Dry Granulation and the Compression Process
Meaningful application of PATs
Common Scale-up issues and troubleshooting
Integrating material science concepts in drug product development to simplify formulation and speed up process development
Application of stability simulations to identify shelf life-limiting Quality Attributes and complement real time stability studies
Takeaways & Special Features
• Industry approaches for scaling-up of solid dosage forms applying QbD principles
• How to translate theoretical scale-up models and current regulatory guidances into practice – What is really relevant?
• Knowledge of formulation, process transfer and validation for commercial drug production. Practical knowledge during the interactive sessions and workshops
JOIN US IN MUNICH
Munich, the third most populous city in Germany, is famous for its beautiful architecture, fine culture, and the annual Oktoberfest beer celebration. Munich represents the balance between the ability to stay at the forefront of technological developments and maintain its cultural heritage.