CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
March 19 - 21. 2018
Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)
Quality by Design (QbD) means that, starting from the very first development step, products and processes are designed in a way to ensure a high level of quality and reliability. One of the main QbD tools is statistical Design of Experiments (DoE), which enables to perform the necessary experiments in an efficient and structured way. This constitutes the most effective manner to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) that, together, influence most the quality characteristics of highest concern, the so-called Critical Quality Attributes (CQA’s). Of course, the methodology can also be applied to optimize existing products or processes.
The training gives a comprehensive introduction to statistical Design of Experiments (DoE): on the one hand, the statistical background is explained, on the other hand, the methods are illustrated with examples from the pharmaceutical and chemical industry, and their application is trained with many exercises based on real-world case studies using a DoE software tool. A part of the last afternoon is reserved for discussing the participants’ own applications. The practical aspects are addressed at regular intervals throughout the whole course duration, so that the course overall proposes a balanced combination of methodological knowledge and practical aspect.
Topic areas to be discussed include, but are not limited to:
- The importance of Quality by Design (QbD) as part of an efficient QA strategy
- DoE vs. one-factor-at-a-time
- The sequential approach of DoE: screening, modelling and optimization – which design in which context?
- Definition of a practical problem as the first step of the application of DoE
- Factor screening and modelling: how to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) as well as their interactions
- Optimization of a response variable with response surface models
- Graphical visualization and interpretation of the results
DoE for formulations
- Defining the Design Space
- Robustness issues
- Accounting for real-world challenges: complex restrictions, unsuccessful experiments
Who Should Attend
This comprehensive three-day course is designed for chemists, engineers, pharmacists and biotechnologists in research, development and production, as well as for laboratory staff involved in the development or optimization of products and processes. The course covers active ingredients as well as formulated products and is of interest not only to the pharmaceutical and biotechnological sectors, but also to scientists working in the chemical and cosmetics industry.
No previous statistical or mathematical knowledge is necessary. Since the knowledge acquired is software-independent, the training will be of great benefit to anyone who intends to apply DoE or wants to do it better, whichever software tool he/she uses, even if a specific user-friendly tool (the DoE expert system STAVEX) is employed in the course to highlight the practical aspects of the methodology.
Philippe Solot, Ph.D.
Specialties: Regulatory, International
Dr. Philippe Solot is Chief Executive Officer of AICOS Technologies, a company which he co-founded in 1997 and which is specialized in facilitating the use of statistical methods by scientists active in the process industry. He previously served five years as Consultant in the Scientific Services department of Ciba-Geigy Ltd., the multinational chemical-pharmaceutical company that merged with Sandoz to form Novartis.
Dr. Solot looks back at more than 20 years of industrial expertise. His specialization is mathematical optimization, in particular its application in improving development and production processes in the pharmaceutical and chemical sectors. He regularly teaches courses on Design of Experiments, data visualization and analysis, Six Sigma and Statistical Process Control. He also gives lectures at Swiss and French universities and is the author of approximately 20 scientific publications in journals such as the International Journal of Production Research and INFOR.
Dr. Solot holds a PhD from the EPFL, the Swiss Federal Institute of Technology in Lausanne, Switzerland. For his doctoral thesis he was awarded the Robert Faure Prize in France by the French AFCET. From 2001 to 2005, he was president of the Swiss Operations Research Society.