Quality by Design (QbD) is based on the application of product and process sciences, from early-to-late stages of the product development cycle, to provide accelerated regulatory submission pathways for new drug applications.
•This is the first MSc dedicated to the new QbD approach to pharmaceutical process and product development •QbD instils quality into the product while it is being developed and manufactured rather than waiting for post-production testing •This forms part of a major initiative, being driven and supported by US, EU, and Japanese regulatory authorities, and defined within the Q8, Q9 and Q10 Guidelines from the International Committee on Harmonization (ICH) •Benefit from investment in new, dedicated good manufacturing practice laboratories, links to the pharmaceutical industry and involvement of industrial practitioners in our course design and delivery
The course contains areas of core knowledge and skills with an emphasis on application of ‘Quality by Design’ principles and continuous improvement activities to the development and manufacture of pharmaceutical products. The course has been structured to ensure you have a coherent and balanced programme of study in the following areas:
• Principles and Practices of Quality by Design • Product Design: Pre-formulation and Formulation • Analytical Techniques in Materials Science • Process Design, Control and Manufacturing • Advances in Drug Delivery • Biopharmaceuticals • Process Analytical Technology and Chemometrics • Experimental Design and Research Methods