Ensuring Quality Through Design Principles

The virtual seminar, "Quality by Design" (QbD), organised by JMP, De Montfort University, AstraZeneca, Direxa Consulting, and the Royal Society of Chemistry Process Chemistry and Technology Group, is set to take place. This event aims to increase the uptake of QbD methodologies in all industries and chemistry types.

Walkiria Schlindwein, an Associate Professor at De Montfort University, will present an introduction to the principles of QbD. With over 25 years of experience in academia, Schlindwein's insight promises to be insightful.

Attendees will learn about the principles of QbD through case study demonstrations. The seminar covers the broad applicability of the QbD approach to process development, including advanced topics such as approaches for specification setting and strategies for traditional and accelerated product development. Julia O'Neill, the Founder & Principal Consultant of Direxa Consulting LLC, will present a QbD approach to specifications.

Robert Shaw and Steph Turnbull, both Senior Scientists at AstraZeneca, will discuss QbD in analytical method development: The analytical method lifecycle. They will delve into the importance of understanding true product requirements, especially for novel breakthrough and orphan drugs where data is limited during control strategy development.

The goal of the seminar is to make QbD principles accessible, practical, and wide-ranging, suitable for both novices and those looking to expand their current knowledge. Ben Valsler, the digital editor of our website magazine, will moderate the panel discussion, which will involve questions from the audience, discussing the value of increased adoption of QbD methodologies, and how more people in more organizations can benefit from QbD approaches.

Phil Kay, a Senior Systems Engineer at JMP, will also participate in the discussion, bringing his background in applied statistics, chemistry, and digital printing process development to the table. The seminar focuses on introducing the principles of Quality by Design (QbD) and its role in enabling organizations to consistently deliver high-quality products in the face of complex technologies, risk factors, and many sources of variation.

In the QbD paradigm, specifications are key to linking all other process controls and play a critical role in planning for reliable supply using process capability metrics. This presentation will explore alternative approaches for specification setting and recommend specific strategies for both traditional and accelerated product development.

Join us for this informative and engaging seminar to gain a deeper understanding of QbD and its applications. Don't miss out on this opportunity to learn from industry experts and expand your knowledge in Quality by Design.