Facilitating CMC Development and Regulatory Filings with Phase-Appropriate QbD

Presented by

Tiffany Rau, PhD, Rau Consulting LLC, Phil Ramsey, PhD, Predictum Inc., and Wayne Levin, Predictum Inc.

About this talk

Pharmaceutical and biotechnology companies are under increasing pressure to reduce timelines and costs to speed up the delivery of safe and high-quality products to patients. Even though timelines may change, the activities within the CMC regulatory pathway must be fulfilled and it is essential to look at the CMC program holistically and in early development. Phase-Appropriate Quality by Design (QbD) is a systems approach to drug development and manufacturing that mitigates risk and facilitates regulatory compliance and successful outcomes. In this session, we will give an overview of our strategy for applying phase-appropriate QbD from early process development to commercialization to increase the rates of success. Learn the role of predictive modeling in enhancing QbD and new methods that it employs. Practical topics will include: • Systems thinking in QbD • Introduction to building predictive models from Design of Experiments (DOE) and other data sources, even when only small data sets are available • How to tailor data analysis to be performed during process development to uncover the maximum insights to address existing challenges and mitigate risk throughout the early to late stages. Who Should Attend: Scientists, engineers, and project leaders who work in drug development, process development, technology transfer, or CMC projects in the pharmaceutical and biotechnology industries

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