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Industry Voices: Navigating Regulatory-Compliant NGS Workflows
In this episode, our host Dr. Raed Hmadi engages in an
insightful dialogue with our guest, Aurora Signorazzi, Scientist & Project Leader at Johnson & Johnson. Aurora sheds light on her experiences regarding the validation of in-house NGS-based assays and explores the impact of the ICH Q5A(R2) guideline and the new draft of the 2.6.41 chapter of the European Pharmacopoeia for the detection of viral extraneous agents.
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By GenedataIn this episode, our host Dr. Raed Hmadi engages in an
insightful dialogue with our guest, Aurora Signorazzi, Scientist & Project Leader at Johnson & Johnson. Aurora sheds light on her experiences regarding the validation of in-house NGS-based assays and explores the impact of the ICH Q5A(R2) guideline and the new draft of the 2.6.41 chapter of the European Pharmacopoeia for the detection of viral extraneous agents.