Practical Approaches to Quality by Design (QbD) for Chemical Process R&D and Manufacturing is organized by Scientific Update Ltd and will be held from Oct 16 - 18, 2018 at Radisson Blu Hotel, Frankfurt, Frankfurt, Hessen, Germany.
The target audience for this medical event is Organic Chemists, Development and Production Chemists, Chemical Engineers and Analysts.
Course Description :
QbD is no longer a regulatory initiative; because QbD is good development, QbD is an industry initiative supported by regulators.
This course focuses on practical approaches to accelerated QbD implementation, and it makes practical recommendations for realistic implementation of QbD elements.
Participants will learn how to prioritize process parameters for screening designs, how to design robust processes using statistical design of experiments (DoE), how to bridge the bench and the commercial design spaces using mixing and scale-up calculations, how to quantify process risk, how to select suitable process analytical technology tools (PAT) and more.
Effective technology transfer to pilot and manufacturing plants is also discussed, including process validation in the QbD.
Course Objectives are:
• Prioritize process parameters prior to screening investigations
• Design effective DoE screening matrixes
• Design robust processes and assess key and critical process parameters
• Execute key mixing and scale-up calculations to bridge the bench and the commercial design spaces
• Use an equipment database for effective technology transfer to pilot and manufacturing plants, and CMO’s
• Estimate process risk
• Make strategic decisions on PAT implementation
Speakers:Dr Andrei Zlota
Additional details will be posted as soon as they are available.
Course Fee Details
|Course Fee||:||EUR €2370.00|
|Early Fee Last date||:||NA|