In this hands-on course the key elements of Quality by Design for small molecules and biotech products will be discussed. Participants from pharmaceutical, biotech and generic industry as well as regulators will learn, with practical work on case studies (solid dosage form of a small molecule and manufacturing process for a biotech product), how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM).
In the case studies all participants will prioritise the potential critical formulation and process parameters with QRM, propose, execute and evaluate a DoE to define the critical parameters and eliminate uncritical parameters. The knowledge gained will be used to establish a Design Space and essential elements of the control strategy. Knowledge Management will be introduced to keep the information and knowledge gained transparent and available for the full lifecycle of the product. The case study will demonstrate that a systematic approach to pharmaceutical development and optimisation, respectively, will be faster and will lead to robust processes. Potential internal savings and the regulatory flexibility will be discussed with a key European regulator.
The course will also give an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.