Recorded live at AI in GxP West · May 2026
Strengthening AI Systems with Built-In Cybersecurity and Access Control
Governance, security, and access controls for AI-enabled GxP environments. Where access control breaks down once an AI system touches validated data, and what an inspector expects you to be able to show.
Shelly LaPointe
Director, Quality, Regulatory and Validation Technologies,Thermo Fisher Scientific
What you'll take away
- Building security and access control into an AI system rather than bolting it on afterwards
- Where access control breaks down once an AI system touches validated data
- Governance that holds when a model changes and permissions have to change with it
- What an inspector expects you to show about who accessed what, and when
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Strengthening AI Systems with Built-In Cybersecurity and Access Control
Sessions like this one are what AI in GxP Puerto Rico is built on. Keep scrolling for 35+ more, live in San Juan on November 3 and 4.
If you liked this session, there are more like it at
AI in GxP Puerto Rico
November 3 & 4, 2026 · San Juan, Puerto Rico · In person
Advance rate $1,295, first 15 attendees through September 11
November 3 and 4, 2026 · San Juan, Puerto Rico
Where the rest of the sessions are.
Two days, twenty-six sessions, and a faculty of practitioners presenting the work they run: AI governance and ownership, acceptance criteria for AI validation, deviation intelligence, cybersecurity and access control, and the inspection questions nobody has clean answers to yet. Plus the all-industry panel on piloting AI in GxP.
Cybersecurity
Strengthening AI Systems with Built-In Cybersecurity and Access Control
The same subject Shelly presented in San Diego, picked up again in San Juan with a different practitioner and a fresh set of cases.
David ShenbergerPartner, Shenberger Technology
AI governance
Defining Ownership and Accountability for AI Across GxP
Who signs for an AI system, where quality, IT, and the business each hold accountability, and escalation that works when a model behaves unexpectedly.
David ShenbergerPartner, Shenberger Technology
Risk-based assurance
From Validation Evidence to Trust: Risk-Based Assurance for AI-Enabled GxP Systems
What defensible evidence looks like when the system keeps changing, and how assurance replaces one-time validation.
Khaled MoussallyEVP, Compliance Group
Human risk
Reducing Human Risk in GxP: Building Inspection-Ready AI Systems
The failure modes that come from people rather than models, and the controls that hold up when an inspector asks.
Dori Gonzalez-AcevedoFounder and CEO, ProcellaRX
“I came for the AI sessions and left with two SOP templates and a peer group I still email.”
Past KENX attendee, AI in GxP
Speaking from inside the regulated world
Who is on the faculty.
Case studies from the quality, validation, and IT leaders accountable when AI touches a GxP system.
Gilead
Sanofi
Apprentice.io
MedStar Georgetown University Hospital
Dyne Therapeutics
ProcellaRX
RCM Data & Solutions
Compliance Group
Pharmalytik
Shenberger Technology
Kneat
VTI Life Sciences
Lives International
Biocule
George Washington University
See the rest of the sessions in San Juan.
November 3 and 4, at the Hilton Garden Inn San Juan Condado. Twenty-six sessions across two days, in person.
Advance rate $1,295 for the first 15 attendees through September 11, then $1,595. Early Bird pricing holds until October 9, after which prices increase.
