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 3

Quality by Design in Practice

The aim of this module is to present practical case studies demonstrating the use of QbD principles in pharmaceutical product development.

This module will draw on practical examples of the application of QbD principles across a diverse range of product types such as inhalation, sterile product and biopharmaceuticals. The use of QbD principles in analytical method development will also be covered. This module aims to help learners identify how they can apply QbD principles in their work environment.

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