AI and GMP: The 10 Questions Regulators Say They'd Be Asking

AI is no longer the future of pharma. It’s here.

Online - 16 October

Across the industry, pharmaceutical companies are using AI to streamline compliance, reduce deviations, accelerate batch release and improve decision-making. However, as adoption grows, so does regulatory scrutiny.

 

The question is no longer whether regulators will ask about AI.
It’s what they will want to know when they do.


Martin Lush has delivered AI training to current and former regulatory inspectors. After those sessions, he asked them a simple question: 


'Knowing what you now know about AI in pharma, what would you be asking during an inspection today?'


Their answers were sharp, specific and, for many pharmaceutical companies, uncomfortable.


In this free 30-minute webinar, Martin will reveal the 10 questions ex-regulators said they would ask about AI in GMP-regulated environments.

For each question he will explain:

  • Why the regulator would ask it - what sits behind the question and what they are really probing for

  • What a good answer looks like - and what a bad one sounds like

  • Where most companies have gaps - the blind spots that could trip you up

 

Who should attend?

Whether you are a QP responsible for batch release, a QA Manager building AI governance, or a Quality Director setting strategy, these are the questions your team needs to be prepared for.

Meet our speaker

 

 

 

 

 

Martin Lush

Martin is one of the pharmaceutical industry's most recognised voices on the practical application of AI in GMP-regulated environments. Formerly Global VP of Pharma, Biotech and Medical Devices at NSF, Martin now works with pharmaceutical organisations worldwide, helping quality, operations and leadership teams adopt AI safely, compliantly, and effectively.

His insights are drawn from hands-on work with more than 25 pharmaceutical companies actively using AI and his courses have been attended by current and former regulatory inspectors. 

RSSL has partnered with Martin to bring this highly regarded training to our course portfolio - combining his industry-leading expertise in AI for pharma with our 30+ years of experience in pharmaceutical professional development.

Register your place

Need to contact us? Get help or ask us a question