SMIMA1091U Quality by Design (QbD) in Pharmaceutical Development

Volume 2026/2027
Education

Master of Industrial Drug Development (MIND) - elective

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.

Content

Quality by Design (QbD) lies at the core of modern pharmaceutical development, offering a scientifically sound and cost-efficient pathway to delivering high-quality medicines to patients. Global regulatory authorities — including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) — now emphasize QbD principles as an integral part of regulatory submissions. As a result, QbD has become a cornerstone of streamlined, risk-based 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). Guided by leading experts from industry, academia, and regulatory agencies, participants will gain both a conceptual understanding and practical insight into how QbD strategies can be effectively implemented within their organizations.

Through interactive lectures and practical demonstrations, the course equips participants with the skills to apply QbD methodologies across the product lifecycle — from design to commercialization.

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

Who Should Attend:
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.

Learning Outcome

After completing the course the student must have gained the following knowledge, skills and competencies:

Knowledge

  • summarize the principles of the QbD approach in pharmaceutical development and manufacturing
  • demonstrate basic knowledge about risk management, design of experiments and PAT
  • demonstrate basic knowledge about the relationship of the QbD approach into design space and further, into the regulatory framework


Skills

  • apply basic risk analysis and design of experiments techniques into practical cases

  • identify and suggest suitable process analytical tools for a given manufacturing environment

Competencies

  • work in a multidisciplinary risk management team
  • plan and implement basic design of experiments (DoE) approach

  • suggest a QbD approach for constructing a design space.

The common course syllabus is a collection of legislation, presentations (hand-outs) and cases, approx. 300 pages.

Applicants must meet the following criteria:
• 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.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English
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.
  • Category
  • Hours
  • Class Instruction
  • 40
  • Preparation
  • 22,5
  • Exam
  • 20
  • Total
  • 82,5
Collective