Building Practical Skills for Biomanufacturing and Biotech
Quality by Design
Discover how to integrate quality into every stage of product development through practical, hands-on learning. This foundational e-learning course introduces the principles of Quality by Design (QbD) using an agile and interactive approach.
Participants explore real-world case studies and gain the skills to identify, assess, and control critical variables in biomanufacturing and biotech — ensuring innovation meets safety, efficacy, and regulatory standards.
This course also serves as a strong foundation for progressing into the advanced Quality by Design: Expanding Expertise in AI, Regulation and Continuous Improvement programme.
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What you get
PRACTICAL APPLICATION
Gain hands-on experience applying Agile Quality by Design to real biotech case studies using the easyQbD platform
INDUSTRY-RELEVANT TOOLS
Master practical QbD tools including FMEA, Ishikawa diagrams, process mapping, and design of experiments
FOUNDATIONAL MASTERY
Understand the principles and structure of QbD to design safe, compliant, and efficient bioprocesses
FLEXIBILITY
Study at your own pace with an online format designed to fit your schedule
HANDS-ON
Apply QbD through interactive exercises and real-world case studies
CERTIFICATION
Receive certification validating your Quality by Design skills and knowledge
EXPERT GUIDANCE
Learn directly from leading experts behind Europe’s most renowned institutions in QbD
CAREER PATHWAY
Build a strong foundation to progress into EIT Health QbD programmes
What you'll learn
Learning Outcomes
- ✅ Understand how Quality by Design ensures quality from the start of product development
- ✅ Identify key quality attributes, material attributes, and process parameters
- ✅ Complete and interpret TPPs and QTPPs using practical case studies
- ✅ Apply criticality assessment tools such as FMEA and process mapping
- ✅ Run basic design of experiments to analyse and optimise process variables
- ✅ Use Agile QbD methods to adapt development workflows quickly and efficiently
- ✅ Build confidence applying QbD principles across preclinical and clinical projects
Curriculum
Eligibility Requirements
Open to students, early-career researchers, and young professionals interested in gaining foundational skills in Quality by Design (QbD) and its application to biomanufacturing and biotechnology.
Note: We recommend following this course with Quality by Design: Expanding Expertise in AI, Regulation and Continuous Improvement to deepen your expertise and apply advanced QbD methodologies.
Partners
CYBERNANO
University Medical Center Utrecht
