AI Governance for Pharma Teams: What Auditors Will Care About
AI Governance for Pharma Teams: What Auditors Will Care About
- 0:00 Audit Lens On AI
- 7:00 Map The Real Use Cases
- 17:00 Classify GxP And Data Risk
Practical shifts you can apply this week
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Identify Expected Governance Controls
See the controls auditors look for first, from AI inventory to ownership and approval paths.
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Evaluate GxP And Data Risk
Assess tools and workflows for regulated impact, sensitive data exposure, and missing documentation.
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Compare Oversight By System Type
Match validation, monitoring, and change control to copilots, embedded AI, and custom models.
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Draft A Defensible Evidence Trail
Link use, oversight, testing, and decision accountability so an auditor can follow the story.
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Decide First Remediation Actions
Prioritize the fixes that reduce audit exposure fastest instead of boiling the regulatory ocean.
What we'll cover
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0:00
Audit Lens On AI
Where auditors start: known use cases, allowed purpose, accountable owners, and compliance risk.
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7:00
Map The Real Use Cases
Find shadow AI, vendor-embedded features, and intake questions that surface hidden exposure.
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17:00
Classify GxP And Data Risk
Use a simple scheme to tier patient, product, record, and data sensitivity risks.
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27:00
Validation Beyond Buzzwords
Define intended use, fit-for-purpose testing, human review limits, and internal vs vendor evidence.
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37:00
Documentation Auditors Can Follow
Build traceability from risk to control with approvals, SOP links, and decision logs.
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45:00
Monitoring Change And Drift
Cover post-go-live checks, change triggers, prompt updates, drift thresholds, and escalation signals.
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52:00
Ninety-Day Readiness Plan
Recap the framework, then leave with a short plan to inventory one live use case and close key gaps.
Questions people ask before registering
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It is for working professionals in pharma and adjacent teams such as quality, regulatory, clinical, medical affairs, IT, data, and compliance. If AI use is showing up in your workflows or audits, this is for you.
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No. The session focuses on governance, documentation, risk, and audit readiness rather than model math. We use concrete examples, not a parade of acronyms.
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Yes, a replay will be available to registered attendees. That helps if your calendar behaves like a quality event log.
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No. We cover both clearly regulated use cases and the gray zone where non-GxP tools can still create data, record, or process risk. Auditors often care about that boundary.
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Practical takeaways. You will leave with a framework to inventory one live AI use case, classify risk, document controls, and prioritize remediation over the next 90 days.
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If a certificate of attendance is offered, it will be shared after the session details are finalized. This webinar is not presented as CE-credit training unless explicitly stated on the registration page.