Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|September 19, 2011
Compliance Insight Podcasts: Implementing Process Validation - Episode 2
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Step-by-Step Validation for Bio/Pharmaceuticals: Meeting New Regulatory Expectations
Implementing Process Validation - Episode 2
Listeners will learn the differences between traditional process validation and new regulatory expectations under the 2011 FDA Process Validation guidance, including how to implement changes to meet a life-cycle approach, what tools can best monitor and assess performance, and how to perform qualification as well as verification under the new guidance. Unique differences between US and European validation guidelines are also discussed.
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