In this hands-on course the key elements of Quality by Design, i.e. 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 will be introduced. In a case study 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 gained information and knowledge 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.
This course is a hands on course full of practical work. It is necessary that you bring your laptop with you.
- Prior Knowledge, Knowledge Management and QTPP-Development
- Initial Risk Assessment (FMEA), Introduction to Process Characterisation and Design of Experiments
- Experimental Work, Multivariate Data Analysis (MVA) and Knowledge Space Establishment
- Design Space Definition
- Control Strategy
- Technologies Assisting QbD-Approach, Regulatory Flexibility