iRisk at Corden Pharma: A Global Application for 10 Sites and a Case Study of QRM-driven Integration of PAT Tools in a Contained Plant

Dr. Iris Ziegler

Director QbD & Pharmaceutical Sciences

Corden Pharma

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The presentation will share insight on Corden Pharma’s journey of deploying iRisk as a centralized QRM application over all sites and the benefits of this implementation for the development and lifecycle management of Corden Pharma's products. In addition, an examination of the obstacles and lessons learned, as well as the identified solutions. The presentation will feature a case study on the selection and implementation of PAT tools for a novel oral drug product manufactured in a contained plant.


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