WEBINAR – Associating digital tools and QbD to speed-up process development: a few simple and hopefully rational considerations.
Online, 25th March 2021
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:
- The statistical approach, using mathematical functions to represent as well as possible the experimental data available
- The mechanistic approach, based the understanding and representation of physico-chemical phenomena and on the determination of a few model parameters by experimentation
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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