Course overview
This foundational course introduces the principles of Quality by Design (QbD) through practical, hands-on learning and real-world case studies. Participants will explore how to identify, assess, and control critical quality factors in biomanufacturing and biotech projects, building the skills needed to support innovation while meeting regulatory and safety expectations.
What you will learn:
- Understand the principles of Quality by Design and its role in product development.
- Identify critical quality attributes, material attributes, and process parameters.
- Apply tools such as FMEA, process mapping, and design of experiments to optimise processes.
- Use Agile QbD approaches to support flexible and efficient development workflows.
- Apply QbD principles to improve quality, compliance, and decision-making across healthcare innovation projects.
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