Pharma / BiotechMedical DeviceSkin & Cosmetics
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:
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.
After completing the course, the participants will have a thorough understanding of the concepts of statistical Design of Experiments (DoE). They will have gained confidence thanks to the many practical exercises, so that they can solve practical problems easily and efficiently in their daily work, when developing or optimizing products and processes in the QbD context. Among the advanced topics, the participants will in particular learn how to deal with typical complex practical situations such as the simultaneous optimization of several potentially contradictory Critical Quality Attributes (CQA’s), the optimization of formulations or the consideration of technical difficulties like an imprecise setting of the process parameters.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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