SMIMA1091U Quality by Design (QbD) in Pharmaceutical Development
Please note this is course description is for the study year 2014/2015. For updated information on dates, prices etc. in other semesters please visit www.mind.ku.dk.
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
The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme, the Master of Pharmaceutical Regulatory Affairs (MPRA) programme and Master of Drug Management (MDM) programme and open for freelance students who meet the admission criteria. Students who gain admission to courses will receive an invoice and an admission letter.
Quality by Design (QbD) is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides cost-efficient approach for delivering high quality medicines for patients. Regulatory authorities - both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) - are placing great emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element of a stream-lined drug development process.
This course will provide an insight into the key principles of
QbD covering quality risk management, formal experimental design
and process analytical technology (PAT). Leading QbD experts – from
industry, regulatory and academic side – will introduce the current
knowledge on QbD and provide participants with ideas how this
knowledge can be implemented in your company. The course includes
The course will provide a thorough introduction to the underlying principles and tools required for QbD-based pharmaceutical development and manufacturing:
- Basic risk analysis techniques
- Constructing the quality target product profile (QTPP)
- Identification of critical quality attributes (CQAs) and critical process parameters (CPPs)
- Design of Experiments (DoE): Basic screening designs, expanded designs
- Process Analytical Technologies (PAT): basic principles of chemometrics, purpose of process measurements in pharmaceutical development and manufacturing, examples of process measurement techniques
- Risk based regulatory framework.
After the course, you will be able to:
- 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
- apply basic risk analysis and design of experiments techniques into practical cases
- identify and suggest suitable process analytical tools for a given manufacturing environment
- 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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- Class Instruction
- 3 ECTS
- Type of assessment
- Written assignmentAn essay based on a selected QbD case and the common course syllabus. The essay must be 8-15 pages.
- Exam registration requirements
Active participation in the course is a prerequisite for assessment.
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
Deadline for submission of written report: 30 September 2014 at 4 PM
Criteria for exam assesment
To pass the exam, the participant must have:
- Written a comprehensive and structured report on a selected case in his/hers own words, which is based on relevant literature.
- Demonstrated an ability to find, understand and report relevant literature for the selected case.
- Demonstrated knowledge of the principles and terms used in the field of QbD in pharmaceutical development.
- Demonstrated an understanding of the central concepts and disciplines relevant for the selected case.