“THE IMPORTANCE OF STATISTICS IN DESIGN QUALITY –
How to use statistical tools in a risk-based approach to optimize formulation and development in QbD “
This workshop is organized by a research scientist in the field of R&D with the aim of providing theoretical information on the importance of using statistics to optimize processes.
The first day will be dedicated to the introduction of the principles of Quality by Design and Quality Risk Management which have become an integral part of the drug development process with ICH from Q8 to Q12.
The second day will be dedicated to statistics and the main theme, one of tradition and one of innovation: the factorial DoE and the Analytical Quality by Design.
Factorial Factor: it’s the most effective tool in the pharmaceutical field and throughout the drug development process, thanks to its versatility and the possibility of applying it to different contexts and scenarios
Analytical quality by definition: how to use the method for the development and validation of an analytical method (with reference to ICH Q14 – Guideline for the development of the analytical procedure and ICH Q2 (R1) – Analytical validation).
Through the presentation of practical cases, thanks to the work experience, we deepen the use of statistical tools, in particular the factorial DoE, in different implementation scenarios, on different types of pharmaceutical processes and forms.
In particular we will explore in a synergistic way to obtain the best result in terms of quality, costs and results.
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For more information and to register contacts:
Laura Monica – Administrative and scientific secretariat – email@example.com