AI Governance for Pharma Teams: What Auditors Will Care About
- 0:00 Audit Lens On AI
- 8:00 Use Cases That Raise Flags
- 18:00 Evidence Beats Policy
Practical shifts you can apply this week
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Identify Risk Tiers That Trigger Governance
Spot which pharma AI uses need tighter oversight based on GxP impact, safety, records, and accountability.
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Compare Policy With Audit Evidence
See what auditors ask for beyond a tidy policy, from approvals to versioned records and training proof.
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Evaluate Controls Auditors Will Test
Review validation, vendor oversight, data integrity, change control, and human review in one framework.
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Diagnose Gaps Before Findings Happen
Catch the weak spots that let a reasonable pilot drift into an avoidable audit issue.
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Draft A Minimal Audit-Ready Documentation Set
Leave with a lean record set you can adapt to one live AI-enabled process within 30 days.
What we'll cover
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0:00
Audit Lens On AI
How auditors frame risk: what the tool does, what it affects, and who owns the output.
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8:00
Use Cases That Raise Flags
Which AI uses draw scrutiny in pharma, including GxP-adjacent gray zones and higher-risk examples.
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18:00
Evidence Beats Policy
What counts as proof in practice: approvals, traceability, training, and versioned records tied to use.
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27:00
Controls Auditors Will Test
A practical walk-through of intended use, human review, output checks, change control, and incidents.
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39:00
Vendor Oversight And Data Records
How to handle supplier claims, SaaS drift, prompts, metadata, audit trails, and retention.
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43:00
Mock Findings, Recap, Q&A
Common findings, quick fixes, and the 30-day review: pick one use case, name the owner, close top gaps.
Questions people ask before registering
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It is for working professionals in pharma, biotech, CRO, quality, regulatory, PV, IT, and compliance roles who touch AI-enabled processes. If auditors could ask your team about an AI workflow, you will have context to use.
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No. The session focuses on governance, evidence, records, and control design rather than model building. If you can follow an SOP and survive an audit, you are in good shape.
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Most webinar programs provide a replay to registered attendees, but availability depends on the host's setup. Register to receive the event details and any follow-up materials.
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Not only. We cover both regulated and adjacent use cases, with emphasis on where scrutiny rises fast, such as safety, quality, submissions, and records that influence decisions.
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You will leave with a practical framework and a clear checklist for a 30-day governance review of one live use case. The focus is a minimal, audit-ready documentation set rather than a binder thick enough to stun a raccoon.
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Certificate and CE availability depends on the webinar host. Check the registration page or confirmation email for the final attendance and accreditation details.