In this short course the key elements of Quality by Design for small molecules and biotech products will be discussed. Participants 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 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 will be faster and will lead to robust processes. Potential internal savings will be discussed 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.

This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.

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