Quality by Design (QbD) in Pharmaceutical Development
Quality by Design (QbD) is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US 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 in a streamlined drug development process.
This course will provide insight into the key principles of QbD covering quality risk management, formal experimental design and process analytical technology (PAT). Leading QbD experts’ from industry, the regulatory side and the academic world will introduce the current knowledge on QbD and provide participants with ideas about, how this knowledge can be implemented in your company. The course includes practical demonstrations.
What you will learn
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 (DoE) 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 experiment design 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 a basic design of experiments (DoE) approach
- Suggest a QbD approach for constructing a design space
The course will introduce 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 and expanded designs
- Process Analytical Technologies (PAT): Basic principles of chemometrics, examples of process measurements both with examples of small molecule and biopharmaceuticals
- Risk-based regulatory framework
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 offer an excellent introduction for those less familiar with QbD. Those with more experience with QbD gain access to new ideas on how to further implement the company's QbD programme. The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme and the Master of Pharmaceutical Regulatory Affairs (MPRA) programme. It has been developed in co-operation with the Steering Committee of the EUFEPS QbD and PAT Sciences Network (EUFEPS, European Federation for Pharmaceutical Sciences).
- Hold a relevant bachelor degree or equivalent
- Have a minimum of 2 years of relevant job experience
- Have proficiency in English
5 days, 14 – 18 August 2017, 9:00 – 16:30 at the University of Copenhagen, Frederiksberg Campus
Other course teachers
Staffan Folestad, Professor, Senior Principal Scientist, Astra Zeneca, Sweden
Wim Oostra, PhD, Technical manager, Abbott Healthcare, The Netherlands
Øyvind Holte, PhD, Scientific officer, Norwegian Medicines Agency, Norway
Erik Skibsted, PhD, Principal Scientist, Novo Nordisk A/S, Denmark
Morten Allesø, PhD, Pharmaceutical Scientist, H. Lundbeck A/S, Denmark
Additional speakers may be included.
EUR 2,600/DKK 19,000. Fee includes teaching, course materials, and all meals during course and examination.
An optional examination is provided, 3 ECTS credits at Master's level, if an essay, based on an extended literature list, is handed in before ultimo September 2017. The exam is obligatory for master’s students. Read more here.