Quality by design (QbD) in pharmaceutical development

After the course, you will be able to:

• Summarize the principles of the QbD approach in pharmaceutical development and manufacturing
• Demonstrate basic knowledge of risk management, Design of Experiments (DoE) and Process Analytical Technology (PAT)
• Demonstrate basic knowledge of how the QbD approach can be applied in design space and further in the regulatory framework
• Apply basic risk analysis and experiment with design techniques using practical case studies
• Identify and suggest suitable process analytical tools for a given manufacturing environment
• Work in a multidisciplinary risk management team
• Plan and implement a basic 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 multivariate data analysis (chemometrics), looking at examples of process measurements applied to both small molecules and biopharmaceuticals, and for batch and continuously operating processes
• Data science: Overview of the existing methods for exploring pharmaceutically relevant data with methods ranging from classical statistical approaches to machine learning
• 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 serves as an excellent introduction for those less familiar with QbD, while participants who have more experience with QbD will gain new insight into 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 Medicines Regulatory Affairs (MRA) 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).

Participants must:

• Hold a relevant bachelor degree or equivalent
• Have a minimum of 2 years of relevant job experience
• Be proficient at English

This is a 5-day course that runs in the period 14-18 August 2023 from approx. 09:00-16:30.

• An optional examination is available, worth 3 ECTS credits at Master’s level.
• This takes the form of an essay, based on a comprehensive literature list.
• The course has been preapproved as an elective in the MIND and MRA programmes at the University of Copenhagen.
• The exam is obligatory for Master’s students.

Dates for examination can be found in the exam schedule.

You may find relevant information about the exam in the course curriculum