Practical Approaches to Quality by Design for Pharmaceutical Process R&D and Manufacturing
Tutors: Dr Andrei Zlota
QbD is no longer a regulatory initiative; because QbD is good development, QbD is an industry initiative supported by regulators.
This course focuses on practical approaches to accelerated QbD implementation, and it makes practical recommendations for realistic implementation of QbD elements.
Participants will learn how to prioritize process parameters for screening designs, how to design robust processes using statistical design of experiments (DoE), how to bridge the bench and the commercial design spaces using mixing and scale-up calculations, how to quantify process risk, how to select suitable process analytical technology tools (PAT) and more.
Effective technology transfer to pilot and manufacturing plants is also discussed, including process validation in the QbD.
Screening the Experimental Space
Robust Process Design
Pharmaceutical Process Scale-Up
Process Analytical Technology
Benefits of Attending
- Prioritize process parameters prior to screening investigations
- Design effective DoE screening matrixes
- Design robust processes and assess key and critical process parameters
- Execute key mixing and scale-up calculations to bridge the bench and the commercial design spaces
- Use an equipment data base for effective technology transfer to pilot and manufacturing plants, and CMO’s
- Estimate process risk
- Make strategic decisions on PAT implementation
Who Should Attend
Organic Chemists – working in the pharmaceutical, pigment, agrochemical, explosives or fine chemicals industries
Development and Production Chemists
Chemical Engineers and Analysts
The course fee includes:
- comprehensive course manual
- coffee/tea refreshments breaks throughout each day
- buffet lunch each day
- course dinner on the first evening
- course certificate