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)

Module 7

Dissertation

The aim is to provide each student with an opportunity to consolidate their knowledge of quality by design applied to pharmaceutical development by carrying out a research or development project in an area directly related to pharmaceutical product design, development or manufacturing.

The dissertation will require the application of many elements of the skills and knowledge acquired in the other modules of the programme Programme. Learners will be expected to apply the knowledge they have gained across the modules to a real-life or simulated situation. They will be expected to utilise the breadth of their knowledge across the range of specialities that come together within the QbD framework to demonstrate an holistic approach to problem solving.

The work will involve data collection and analysis. Each student will be expected to gather data and to plan ongoing strategies for continued study. Tutorials will be delivered on topics such as: information retrieval, scientific practice and dissertation design.

For more information about content, learning outcomes and the industry experts providing the lectures please email qbd@dmu.ac.uk.