On demandRegulatory Compliance

AI in GxP Environments: What Every Pharma IT Leader Must Know

In this webinar, Dr. Ajaz Hussain, Ex. Deputy Director of U.S. FDA, shares what it truly takes to deploy AI responsibly in regulated pharma operations.

Speaker
Dr. Ajaz Hussain
Ex U.S. FDA Director
Runtime
50 min
Access
Free, sign-in required
About this session

With over three decades of experience spanning machine learning research, FDA policy development, and pharmaceutical quality systems, Dr. Hussain brings rare, first-hand authority to one of the most pressing questions facing pharma IT leaders today.

📌 What This Session Covers:

  • 54% of pharma companies have no AI in GxP.

  • ML, GenAI, and Agentic AI are not the same thing in GxP, and confusing them could cost billions.

  • Most companies are stuck in compliance theater.

  • FDA issued a warning letter for AI-generated drug specs.

  • Before deploying AI in GxP, can you prove your people, processes, and products are stable?

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Disclaimer: The views and opinions expressed in this episode are solely those of the guest and do not necessarily reflect the official policy or position of Pharma Now or any organisation they are affiliated with. This conversation is intended for informational and educational purposes only. We are here for honest, unfiltered conversations that move the industry forward.

Your speakers

Speaker
Dr. Ajaz Hussain
Ex U.S. FDA Director
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