Module 1 - Regulatory Guidelines, Principles and Tools of QbD (30 credits) Module 2 - The QbD Product Development Roadmap (30 credits) Module 3 - Quality by Design in Practice (30 credits) Module 4 - Manufacturing, Process Controls & Inspection (15 credits) Module 5 - Negotiated Studies (15 credits) Module 6 - Research Methods (15 credits) Module 7 - Dissertation (60 credits)

Programmes and Modules

Students can choose to study individual modules, a PG Cert, PG Dip or full MSc.

Study individual areas of interest

Students who do not wish to gain a formal qualification at this stage can choose to study individual modules to suit their continued professional development and employer needs. Students can choose from modules 1-4. It is advised that students with no prior knowledge of the basic regulations, QbD principles and tools should undertake module 1 prior to studying any further modules.

Qualifications

Although it is anticipated that most students will complete the full MSc the programme has been designed with “step-off points” allowing students to exit the course at specific points with recognised PG Cert, PG Dip awards.

The students are expected to complete 60 credits per year. The programme is structured in a logical manner to allow the students to gradually develop knowledge and understanding through recorded lectures and a guided study pack.

PG Certificate (60 credits)

Module 1 is compulsory (unless students can demonstrate a prior understanding). Any other module(s) may be studied in order to complete the 60 credits required for the Certificate.

PG Diploma (120 credits)

Once students have completed the Certificate they may progress onto the Diploma by taking a further 60 credits. Those 60 credits will be comprised of one 30-credit module together with two 15-credit modules (selected from Modules 4, 5 and 6).

MSc (180 credits)

The full MSc consists of 6 out of 7 modules totalling 180 credits, including a 60 credit dissertation. To gain the MSc students will complete a dissertation worth 60 credits (Module 7). Note that students must have already completed the Research Methods module (Module 6) prior to the dissertation. A total of 180 credits are required for the full MSc course (there are 195 credits available from seven modules). Modules 4 and 5 are an either/or option for students doing the full MSc.