Quality by design (QbD) in pharmaceutical development
Get insight into the key principles of Quality by Design including quality risk management, formal experimental design, process analytical technology (PAT) and related data science.
Quality by Design (QbD) offers a practical, science‑based way to develop and produce medicines with consistent, high quality.
Regulatory authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) now highlight QbD as an essential element of regulatory submissions. Because of this, QbD has become a key approach for creating more efficient, risk‑based processes in drug development and manufacturing.
This course provides an in-depth exploration of QbD principles, spanning quality risk management, formal experimental design, and process analytical technology (PAT).
With guidance from experienced experts from industry, academia, and regulatory bodies, you will gain both a solid understanding of QbD and practical insight into how to use it in your own organization. Through lectures and hands‑on demonstrations, the course helps you apply QbD methods throughout the entire product lifecycle — from initial design to commercial production.
Key Learning Topics:
- Fundamentals of risk analysis and quality management
- Developing the Quality Target Product Profile (QTPP)
- Identifying Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
- Applying Design of Experiments (DoE): from basic screening to advanced designs
- Understanding Process Analytical Technologies (PAT): chemometrics, process monitoring, and measurement techniques
- Navigating the risk-based regulatory framework for QbD implementation
I really enjoyed the setting, flow and pace of the course. It allowed time for reading, lectures, group work, discussion and reflecting. There were several very practical take always from this week, and also key points to further investigate and reflect on. I think it gives a very good understating of the topic of QbD and how to and use these application in development work.
Very innovative and well organized
Excellent course, will recommend to other colleague
Course director on Quality by design
Learning outcomes of »Quality by Design (QbD) in Pharmaceutical Development«
Course details concerning Quality by design
Schedule and delivery
Dates
17-08-2026 08:15-17:00
18-08-2026 08:15-17:00
19-08-2026 08:15-17:00
20-08-2026 08-15:17:00
21-08-2026 08:15-17:00
Teaching methods
The course is organized as an intensive 5-day course and comprises lectures, group discussions, presentations and discussions.
In order to emphasize the flow of the process, the course is to a large extent based on the use of cases in both lectures and assignments.
The common course syllabus is a collection of legislation, presentations (hand-outs) and cases, approx. 300 pages.
Target audience
The course is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The course will be an excellent introduction for those less familiar with QbD and will provide those with more experience on QbD with new ideas on how to further implement the company’s QbD programme.
This course is designed for professionals and lifelong learners in the pharmaceutical and biopharmaceutical sectors - including, e.g., formulation scientists, process engineers, regulatory affairs specialists, and quality professionals - who wish to enhance their expertise in QbD principles and practical applications.
Admission requirements
You must meet the following criteria to be admitted to this course:
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Have a bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
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Have at least two years of relevant work experience related to development of medicines
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Be proficiency in English
Fee
EU/EEA citizens
14.450 DKK
Non-EU/EEA citizens
16.580
More information
All course information is available in the course curriculum:Location
University of Copenhagen
South Campus
Njalsgade 76
DK-2300 København S
Denmark
Contact
University of Copenhagen
Continuing and Lifelong Learning
lifelonglearning@adm.ku.dk