Course overview
The objective of the course will be to teach the principles and applications quality by design and process analytical technology as practiced by the pharmaceutical industry. The course is designed so students will be able to understand and discuss the basic principles of quality by design and process analytical technology. They will also be able to apply quality by design and process analytical technology to the biopharmaceutical manufacturing.
Course learning outcomes
- Understand the principles behind Quality by Design (QbD); critical quality attributes (CQAs), critical material attributes (CMAs, critical process parameters (CPPs), design space and control strategy.
- Understand the principles behind risk assessment and risk-based quality management of pharmaceutical products.
- Demonstrate the ability to apply QbD to a pharmaceutical process.
- Understand the principles behind process analytical technology (PAT) and its application to to a pharmaceutical processes.
- Demonstrate the application of PAT to a pharmaceutical process.