QbD is strongly promoted by regulatory bodies and remains quite puzzling for many practitioners.
Thierry Bastogne (CyberNano) and Roger-Marc Nicoud (Ypso-Facto) will explain how QbD is essentially a rational approach to sound process development, based on solid experimental data and – ideally – a good understanding of the underlying theoretical concepts.
In particular, they will present and differentiate between two approaches to modeling:
They will give insights on how to choose between these two approaches or a mix of both, or even none of them, depending on what one needs, what one knows, and what data one has in hands.
A few practical examples will help demonstrate the power and limitations of each approach;
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Ypso-Facto is a service company helping industrial firms to develop, optimize and secure their chemical processes and bioprocesses.