Expanding Expertise in AI, Regulation and Continuous Improvement
Quality by Design
Advance your Quality by Design (QbD) expertise and discover how regulatory, analytical, and digital innovation come together to deliver safer, more efficient healthcare solutions.
Building on the foundations of Quality by Design: Building Practical Skills for Biomanufacturing and Biotech, this advanced course explores modern QbD applications in depth — including Reverse and Analytical QbD, AI integration, and lifecycle management. Participants will learn to optimise existing products, ensure regulatory alignment, and apply data-driven strategies for continuous improvement across biotech, pharma, and medtech projects.
It is recommended to have completed Quality by Design: Building Practical Skills for Biomanufacturing and Biotech before enrolling to this programme.
Applications to this programme are ongoing. Don’t miss this opportunity and enrol now!
What you get
ADVANCED INTEGRATION
Explore the intersection of QbD with AI, data integrity, and continuous improvement in healthcare innovation.
REGULATORY INSIGHT
Learn how to incorporate QbD deliverables into CTD dossiers and align projects with ICH Q8–Q14 guidelines.
REAL-WORLD APPLICATION
Apply Reverse and Analytical QbD to real pharmaceutical and biotech case studies
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
Become an expert in QbD and lead innovation and best practices across Europe
What you'll learn
Learning Outcomes
- ✅ Apply Agile, Reverse, and Analytical QbD in real-world healthcare manufacturing scenarios
- ✅ Understand how AI and data integrity (21 CFR Part 11, ALCOA+) influence modern QbD practices
- ✅ Optimise existing drug and device manufacturing processes using Reverse QbD
- ✅ Design and validate analytical methods following ICH Q2 and Q14 standards
- ✅ Integrate QbD outputs into CTD dossiers for clinical and marketing submissions
- ✅ Implement lifecycle management and continuous process verification using QbD insights
- ✅ Drive innovation by aligning quality, compliance, and operational excellence
Curriculum
Eligibility Requirements
Open to professionals, researchers, and advanced students in biotech, pharma, or medtech who want to deepen their expertise in Quality by Design (QbD), regulatory compliance, and AI-driven continuous improvement.
Note: It is recommended to have completed Quality by Design: Building Practical Skills for Biomanufacturing and Biotech before enrolling to this programme.
Partners
CYBERNANO
University Medical Center Utrecht
