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.
Testimonials
“The course is well designed to understand the QbD approach, which is now suggested by regulatory bodies” - Johnson Matthey
“Very good and comprehensive training course, with study cases and plenty of interactions with the trainer, which helped us to understand how to apply QbD in our workplace”
“Very comprehensive course, all aspects of QbD are discussed, as well as other topics indirectly related. Very interesting indeed, and the lecturers seemed really knowledgeable and were able to expand besides the main topic.”
“It was an enjoyable experience for the 5-day training course. A lot of knowledge/information was delivered in a relatively short period of time. Highly appreciated!”
We are delighted to provide this course in partnership with Scientific Update.
Stay tuned for the dates of our next virtual training course in collaboration with Scientific Update!
We offer in house face-to-face and virtual courses to meet your specific requirements. Please contact us for more information.