AI Compliance in Life Sciences – EU AI Act and FDA Guidance

Artificial intelligence is already triaging adverse events, screening clinical trial candidates and monitoring production lines across the life sciences. Now the rules have caught up: the EU AI Act and the FDA’s fast-growing AI guidance decide whether your models pass inspection or put your submissions, your reputation and your patients at risk.

This course turns both frameworks into one clear, audit-ready method. Your teams will learn to classify, validate, document and defend every AI system you deploy. From drug development and manufacturing to pharmacovigilance and quality, nothing is left to guesswork. Upon successful completion, you will receive a traceable certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

What you’ll learn

• Map the EU AI Act timeline and the FDA AI guidance ecosystem
• Classify AI with the EU four-tier risk model and the FDA context-of-use framework
• Design AI literacy programs and extend CSV/CSA validation to AI models
• Defend data integrity, explainability, human oversight and generative AI governance
• Build documentation that proves AI compliance for FDA and EMA audits

Who should enroll

• Regulatory affairs and compliance professionals
• Quality assurance and IT/CSV validation specialists
• Clinical operations, pharmacovigilance and data management teams
• Auditors assessing AI governance programs

Curriculum

Lesson: A Brief History of AI in Life Sciences

Lesson 1: Why AI Compliance Now

Lesson 2: AI Risk Classification

Lesson 3: AI Literacy Requirements

Lesson 4: Validation and Lifecycle Management

Lesson 5: Data Integrity for AI

Lesson 6: Transparency and Explainability

Lesson 7: AI in Pharmacovigilance

Lesson 8: Generative AI in Regulated Workflows

Lesson 9: Implementation Roadmap

Conclusion

Glossary

Final Assessment