Quality Risk Management - Kevin O'Donnell
Notes de l’épisode
In this episode of Pharma Conversations Podcast, Kevin O’Donnell (HPRA) explains how QRM needs to move beyond tick‑box exercises to become truly knowledge‑driven and evidence‑based.
He walks through the main changes in ICH Q9(R1) and what regulators expect from companies in practice. We discuss culture, misuse of RPNs and the idea of a “living” QRM system under continuous improvement.
Kevin also shares how these principles apply to emerging areas like ATMPs, digitalisation and AI.
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This episode is sponsored by Ecolab.