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 1

Regulatory Guidelines, Principles and Tools of QbD

The module is designed to provide the fundamental concepts and tools applied to pharmaceutical product design, process design, process monitoring and continuous verification based on Quality by Design principles.

In this module the work-based learners are introduced to the core of the QbD framework, including quality target product profile (QTPP), product and process development (critical quality attributes – CQAs and critical process parameters – CPPs), API development, design space, control strategy and continuous improvement. These principles are underpinned by science, pharmaceutical quality systems, quality risk management and knowledge management. The tools that facilitate the implementation of the QbD approach, such as process analysers, design of experiments, and multivariate analysis will be introduced.

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