You’ve seen the headlines. 

AI hallucinations
Incorrect advice
Systems confidently producing the wrong answer
 
But this isn’t just a tech problem anymore — it’s a compliance risk.
In a recent FDA warning letter, a manufacturer stated they were unaware of a critical requirement because their AI tool “never told them.”

The FDA response was clear: Accountability still sits with you.

Join us for a practical, no-hype session: The Life Sciences AI Reality Check
This virtual event will cover:
✅ Real-world AI use cases in life sciences
✅ Lessons from regulatory action
✅ Governance best practices using the ISPE GAMP AI Guide

📅 08 September 2026 | 12:15–4:00 PM AEST

Whether you’re in validation, quality, or digital transformation — this is a conversation you don’t want to miss.

During the event, chaired by Charlie Wakeham ( Director, WakeUp to Quality Pty Ltd & ISPE Australasia Affiliate Director), you have the opportunity to: 

• Hear from Milica Ng (Biomedical Data Science Executive ex-CSL; Strategic and Scientific advisor Actimo Labs) with her presentation From Mechanistic Models to Agentic AI: Building Data-Centric, Governed Life Sciences Organisations
• Learn Brad Swarbrick's views (Managing Director, KAX Group) on The Role of Artificial Intelligence and Machine Learning in Modern Pharmaceutical Quality Systems.
• Consider if we have reached the end of periodic testing with RK Neelakandan's  (Software Quality and Solutions Lead, Google LLC)  Autonomous Validation for Life Sciences Systems
• Gain insights from Martin Heitmann (MH Consulting &  Advisory GmbH) on AI Governance and AI in GxP: GAMP’s contribution, the EU GMP Annex 22 and Future Perspectives, based on his ground-breaking work as a co-lead and author of the ISPE GAMP AI Guide and a topic lead in EMA's Interested Parties working group on Annex 22.

The event rounds out with all four speakers debating the future and applications of AI in a panel moderated by Prudence Edwards (Senior Engineer - Global MSAT,  Thermo Fisher Scientific & ISPE Australasia Affiliate Director).

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Registration Fees:
ISPE Members: $50.00
Non-Members: $100.00
Students and Regulators: Free

Credit card payment is required at the time of registration.

Register Here

Questions: 
Mandy Bromilow | ISPE Australasian Affiliate
ISPE - Connecting a World of Pharmaceutical Knowledge
T: +61 447 279 008
E-mail: manager@ispe.org.au | www.ISPE.org.au

ISPE Australasia thanks the sponsors

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