Analytical Quality by Design ICH Q14 - a new ICH Quality Guideline
The impact of Quality by Design on the analytical work will be discussed. The participants will learn to understand the concepts and support QbD in the analytical laboratory and in manufacturing. As a consequence, a more efficient analytical method development and routine application should support most economic working practices.
The training will define the essential elements of Quality by Design, Quality Risk Management, and Knowledge Management. In case studies, the participants will apply the concepts in practice. The following elements will be discussed:
- Basic QbD concepts and the QbD process
- Implementation of QbD in the analytical laboratory
- Application of Quality Risk Management for the evaluation of methods
- The role of systematic method development
- Design of experiments for generation of knowledge and understanding
- Basic concepts of Knowledge Management and documentation of analytical methods
- Method transfer requirements
The training consists of lectures, case studies, and intense discussions of results. A script will be distributed to participants.
Depending on the participants, the training can also be given in German, but all written material is delivered in English only.
Frau Esther Wolff
Tel.: +41 58 765 5200
Fax: +41 58 765 5801
Mail: Anfrage versenden
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