Practical Approaches to Quality and Developent by Design, USA, 2019

Memo

QDbD is no longer a regulatory initiative; because QDbD is good development, QDbD is an industry initiative supported by regulators. This course focuses on practical approaches to accelerated QDbD implementation, and it makes practical recommendations for realistic implementation of QDbD 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 QDbD.