Pharmaceutical Quality by Design MSc/PG Dip/PG Cert

The Pharmaceutical Quality by Design course will provides an understanding of the challenges faced by the pharmaceutical and healthcare industries as they strive to develop new products and equips you with modern product development and manufacturing solutions that conform to current industry best practices and modern QbD principles.

The course contains areas of core knowledge and skills with an emphasis on application of QbD principles and continuous improvement activities to the development and manufacture of pharmaceutical products. 180 credits must be completed to achieve a full master’s. The course is structured to ensure you have a coherent and balanced programme of study in the following areas:

• Quality by Design - QbD (15 credits) - explores a variety of legislation and regulations relating to the quality of pharmaceutical products.

• Product Design: Pre-formulation and Formulation (30 credits) - introduces a variety of techniques and methods to formulate and produce safe medicines.

• Analytical Techniques in Materials Science (15 credits) - builds on the concept of materials science as a separate discipline.

• Process Design and Manufacturing (15 credits) - considers the design, including facility, equipment, material transfer, and manufacturing variables using QbD principles.

• Advances in Drug Delivery (15 credits elective) - focuses on new therapeutic entities and delivery strategies. It is intended to integrate with ideas in other subject areas presented in the course, but also for the appreciation of future developments.

• Biopharmaceuticals (15 credits elective) - covers the use of large molecules, including those derived from biotechnology and especially those that are biologically active to produce therapeutic responses.

• Process Analytical Technology and Chemometrics (15 credits) - describes online process monitoring and the use of Process Analytical Technology (PAT) to advance pharmaceutical process identification, simulation and control.

• Experimental Design and Research Methods (15 credits) - focuses on research and experiment design methods applying QbD principles. The importance of design space concept will be discussed. Issues are primarily illustrated through examples from industrial cases.
• Dissertation (60 credits) - aims to provide each student with an opportunity to consolidate their knowledge of quality by design applied to pharmaceutical science by carrying out a research or development project in an area directly related to pharmaceutical manufacturing

The learning environment for the first two semesters is varied with lectures, tutorials, seminars, laboratory-based practical’s and computer laboratories. In the third semester the learning venue will depend on your dissertation topic and will be much more aimed at guided self-study.

The course uses a variety of assessment methods relevant to a master’s level of study. The assessments include oral presentations, group work assignments, case study reports, essay writing, a research proposal and a final dissertation.

Contact hours in a typical week will depend to some extent on the optional modules you choose to study. However, typically you will have an average of 15 contact hours of teaching and this will break down as:

Personal tutorial/small group teaching: 1 hour of tutorials (or later, project supervision) each week

Medium group teaching: 4 hours of practical classes, workshops or seminars each week

Large group teaching: 10 hours of lectures each week

Personal study: 10 hours studying and revising in your own time each week, including some guided study using hand-outs and online activities.