Quality by Design

Quality by Design (QbD) is the FDA-recommended method for the development of drug substances and drug products. The basic idea is to find factor-spaces that grant the desired drug substance/product qualities. After a design space is approved changing the production process inside the design space is not considered a change. This way Quality by Design offers unique flexibility in drug substance and drug product production.

This training covers the basic ideas of Design of Experiments (DoE) the foundation stone of any systematic search for a design space. Learn which important questions are answered by which kind of design. The whole training is based on a FDA-example and represents a whole development process of a drug product. 

Content:

• QbD and DoE
• Statistical Tools: Hypothesis Tests and Regression
• Screening Designs: Identifying Important Factors
• Response-Surface Designs: Finding the Design-Space
• Confirmation Experiments

Requirements:

Students should know how to work with the relevant software. A basic understanding of hypothesis tests and regression is helpful but not required.

Duration of the training: 3 days