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 4

Manufacturing, Process Controls & Inspection

The aim of this module is to present the elements of quality by design used in manufacturing, including advanced process controls as applied to both batch and continuous processing. Practical aspects of a QbD submission will be presented from the perspectives of author, assessor and GMP inspector.

This module considers some advanced manufacturing technology and concepts and also presents the regulatory view of QbD. The learner’s understanding of pharmaceutical product manufacture will be developed to introduce concepts such as real time release and continuous quality verification. Industrial examples of continuous processing will be provided. Lectures contributed by the MHRA will provide a regulatory insight into the application of QbD principles.

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