Sep 11, 2017 - Sep 13, 2017
Clarion Hotel Prague, Old Town
QbD is no longer just 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 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.
Name: Hannah May
Organization: Scientific Update Ltd
Contact Address: Scientific Update Ltd, Maycroft Place, Stone Cross, Mayfield, East Sussex,TN20 6EW, UK