Quality by Design in Pharmaceutical Development (QbD)
in collaboration with Paul Murray Catalysis Consulting Ltd.
QbD is an industry initiative supported by regulators. However, it is also a systematic method of process development which delivers consistency, robustness and increased process knowledge.
This course introduces QbD across all areas of pharmaceutical development including synthesis, formulation and analysis, and suggests practical recommendations for the implementation of QbD.
Participants will learn how to identify and prioritise process parameters, determine and manage risk, and implement control strategies. The use of experimental design (DoE) in QbD, the identification of potential mixing and scale-up problems, and the safe scale up of processes to pilot and manufacturing plants will also be discussed.
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.