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 paradigm.
For the benefit of process scientists, engineers, formulators, analytical chemists and manufacturing personnel, this course includes highly interactive, hands-on workshops, based on several case studies.
Paul is a consultant with expertise in the fields of Catalysis, Design of Experiments, Principal Component Analysis and Process Development. Paul has a proven track record of the timely delivery of innovative solutions to projects resulting in significant reductions in costs and resources to customers.
Paul worked as a Process Development Chemist at AstraZeneca and collaborated with academics at the University of Bristol to develop ligand property maps to enable the use of DoE for the efficient, rational development of catalytic reactions. Paul has 16 publications and 9 patents to date.
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