Pharmaceutical Quality by Design (Taught)

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

Our Leicester School of Pharmacy has an established reputation of more than 100 years of pharmacy teaching. This course is dedicated to applying international regulatory guidelines used by all big pharmaceutical industries to pharmaceutical manufacture and product development.

Our teaching staff are experienced practitioners and researchers, and offer academic and industrial expertise underpinned by Quality by Design principles. You will learn about the challenges faced by the pharmaceutical and healthcare industries in product formulation, material science, advanced analytical sciences, and process engineering and control, as they strive to develop new products and create safe medicines.

Your learning will benefit from our strong industry links, with support from guest lecturers and other experts within the sector. This insight ensures that your studies will be up to date with current practice and developments, preparing you to progress into a wide range of careers, from product development and manufacturing to regulatory affairs, marketing, and clinical research.

Extensive investment in our industry-standard laboratories means that you will have access to specialist equipment throughout your studies. This includes a continuous manufacture platform using a novel in-line based on UV-Vis spectroscopy, powder flow and compression technology, thermal and mechanical analysers, freeze drying and tablet manufacturing facilities.

Applications can be made using the postgraduate application form, or using the online portal. Please send any queries to admissions@dmu.ac.uk

Key features

• Our experienced academic staff have research projects supported by Innovate UK and the Engineering and Physical Sciences Research Council

• This programme prepares you for a wide variety of pharmaceutical career opportunities, from product development and manufacturing to regulatory affairs, marketing, and clinical research.

• Strong industry links and direct input from guest lecturers and experts in the field ensure your learning is relevant to current practice and developments within the sector.

• 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.

• Benefit from block teaching, where most students study one subject at a time. A simple timetable will allow you to really engage with your learning, receive regular feedback and assessments, get to know your course mates and enjoy a better study-life balance.

Modules

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 masters. The course is structured to ensure you have a coherent and balanced programme of study in the following areas:

• Block one: Quality by Design: Fundamental principles (30 credits)  - explores a variety of legislation and regulations relating to the quality of pharmaceutical products.

• Block two: Prod Design: Formulation Development (30 credits)  - introduces a variety of techniques and methods to formulate and produce safe medicines.

• Block three: Process Design: Manufacturing & Process Analytical Technologies (30 credits)  -design and control of manufacturing process based on the understanding of material properties and critical process parameters. The role of process analytical technologies in process identification, simulation and control.

• Block four: Biopharmaceuticals (30 credits)  - covers the use of large molecules, including those derived from biotechnology and especially those that are biologically active to produce therapeutic responses.

• Block five and six: 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.

https://www.dmu.ac.uk/study/courses/postgraduate-courses/pharmaceutical-quality-by-design-mscpg-dippg-cer/pharmaceutical-quality-by-design.aspx

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.