Courses
CLIN-SP-301: AI Governance & GxP Compliance for Sponsors
SponsorsQuality & ComplianceLeadershipGovernance & Compliance
Your teams are already using AI; the only question is whether the organization has a defensible position when an inspector asks about it. This course gives quality and compliance leaders a practical governance framework: the current regulatory landscape, a validation mindset for non-deterministic tools, SOP and acceptable-use policy templates, and an approach to auditing vendors whose services now include AI. The lab produces a draft AI use policy for your own organization, not a generic one.
Sign in to buy
$99.00
10 modules, 3 hands-on labs
What the course covers
- 1Why AI governance cannot wait for regulation
- 2The regulatory landscape: FDA, EMA and the EU AI Act
- 3Validation thinking for non-deterministic tools
- 4Lab: classify the use, then size the assurance
- 5Writing AI SOPs and acceptable-use policies
- 6Lab: draft your organization's AI use policy
- 7Auditing vendors that use AI
- 8Lab: audit a vendor's AI answers
- 9Governance certification quiz
- 10Wrap-up and course feedback
You take the course online, at your own pace, and keep access to it. Questions before you buy? Email Assistance@BCConsulting.io.
Sign in to buySee our refund policy and terms.