Quality by Design
QbD is not only a regulatory initiative, engaging with the principles of QbD leads to good process development. Paul Murray Catalysis Consulting offers training in all aspects of the implementation of Quality by Design including:
- The theory and implementation of Quality by Design including current uses and promised use.
- The Quality by Design process: a step-by-step process for successful QbD.
- DoE for QbD purposes
- The application of QbD to develop safe and robust processes
- The ability to develop and use Quality Target Product profiles (including identifying CQAs, identifying, prioritising and quantifying process parameters and material attributes)
- An understanding of different risk assessment techniques to determine and manage risk
- Ways to determine and implement appropriate control strategies
- Tools to identify potential mixing and scale up problems
- An appreciation of QbD in analytical chemistry, formulation, process development and manufacturing
This training is written and delivered by Paul, a process chemist with extensive experience of applying DoE across the whole range of development activities from reaction screening to optimisation and scale-up. Paul has spent his career using DoE to develop robust processes with enhanced process understanding. QbD is a risk-based strategy to control the desired quality attributes of a drug and DoE is an important method to investigate and understand the relationships between the factors and the quality attributes.
This training course should be attended by: Chemists, engineers, analysts and formulators in pharmaceutical development. Or anyone involved with the development of new or existing drug products; changes or improvements to existing or generic drugs are subject to QbD principals.
“The course is well designed to understand the QbD approach, which is now suggested by regulatory bodies” - Johnson Matthey
We are delighted to provide this course in partnership with Scientific Update.
The next planned virtual open training course in collaboration with Scientific Update will be 15th – 19th November 2021 - Book here!
We offer in house face-to-face and virtual courses to meet your specific requirements. Please contact us for more information.