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 2

The QbD Product Development Roadmap

The aim of this module is to understand the iterative nature of formulation and process design using Quality by Design principles and the link to patient requirements.

This module uses the QbD process flow or roadmap to illustrate the start to end product development process. The recorded lectures cover key areas which impact product or process design such as biophamaceutics and excipient properties. The aim of this module is to demonstrate how QbD principles are applied throughout the different stages of product and process development. Key QbD tools, such as risk assessment are demonstrated through examples and case studies.

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