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.
We are delighted to provide this course in partnership with Scientific Update. The next courses are available in North American and Europe.
4th - 6th March 2020, Clearwater, USA. For more information or to book, click here.
9th - 11th June 2020, Lisbon, Portugal. For more information or to book, click here.
We are also available to deliver this course in-house. Please contact us for more information.