Expert-led training for pharma and biotech professionals. Stay audit-ready, validate with confidence, and lead the future of compliant AI in life sciences.
Trusted by professionals at leading pharma organizations
Every course is mapped to real regulatory requirements — not theory.
Practical, regulation-aligned training covering the full spectrum of compliance, validation, and AI/ML in life sciences.
End-to-end validation frameworks for AI/ML systems in regulated pharma environments. Covers FDA AI Action Plan, risk classification, and GAMP 5 alignment.
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Comprehensive coverage of GMP, GCP, GLP, and GDP. Real-world case studies from FDA inspections and EU GMP audits across manufacturing and clinical ops.
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Modern validation approaches under CSA. From IQ/OQ/PQ to risk-based approaches aligned with FDA's 2022 CSA guidance and GAMP 5 second edition.
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Master electronic records and electronic signatures regulations. Audit trails, access controls, and system lifecycle management for FDA and EMA compliance.
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ALCOA+ principles, data governance frameworks, and audit trail review. Prevents 483s and warning letters through proactive data integrity programs.
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Risk-based thinking applied to GMP operations. FMEA, HACCP, and fault tree analysis methods for pharma manufacturing and quality systems.
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Built by industry veterans. Designed for the realities of modern pharmaceutical and biotech compliance.
Every course is developed by regulators, validation specialists, and senior QA professionals with decades of FDA and EMA experience.
Mobile-first platform with offline access. Train during audits, on the plant floor, or on a flight to a regulatory meeting.
Earn verifiable digital certificates accepted by FDA, EMA, and Notified Bodies. Add them directly to your LinkedIn profile.
Content is continuously updated to reflect the latest FDA guidance documents, EMA guidelines, and ICH harmonized tripartite guidelines.
Manage your entire team's compliance training with our enterprise LMS. Track completions, assign mandatory courses, generate audit reports.
Monthly live sessions with regulatory experts where you can ask your specific compliance questions and get real, actionable answers.
Our curriculum aligns with every major regulatory framework your organization needs:
The AI/ML Validation course completely changed how our team approaches system validation. We passed our FDA inspection with zero observations on our AI-assisted QC system.
Finally, training that doesn't put you to sleep. The GxP content is razor-sharp, practical, and instantly applicable. Our QA team completed the entire compliance track in two weeks.
The 21 CFR Part 11 & Annex 11 course saved us during an EMA audit. The auditor was impressed by our team's depth of knowledge. Worth every penny — and then some.
🚨 New guidance just dropped: FDA's updated framework for AI/ML in drug manufacturing. Here's what your validation team needs to know...
📋 EU Annex 11 vs 21 CFR Part 11: The 5 key differences that trip up compliance teams — and how to address both in one validation strategy.
🎓 Cohort 12 of our GxP Fundamentals certification is now open. 400+ professionals have earned this credential in 2025 alone.
Buy the course you need, or unlock everything with a monthly subscription.
Every course you complete earns you a verifiable, industry-recognized digital certificate — designed to be added to your LinkedIn profile and presented to auditors, regulators, and employers.
Join 12,000+ pharma professionals who train with The Pharma University.