AI Compliance
Training Programs
Equip your team with the knowledge and skills to implement AI responsibly in regulated environments. From EU AI Act compliance to GxP validation strategies, our training programs prepare you for the evolving regulatory landscape.
AI Regulations Are Here
The EU AI Act is now in force. EU GMP Annex 22 addresses computerized systems including AI. FDA continues to evolve its guidance on AI/ML in drug development and manufacturing.
Is your team prepared? Our training programs ensure your organization understands the requirements and can implement AI systems that meet regulatory expectations.
Key Regulatory Milestones
EU AI Act
Risk-based requirements for AI systems
EU GMP Annex 22
Computerized systems including AI/ML
FDA AI/ML Guidance
Evolving expectations for AI in GxP
Training Formats
Choose the format that works best for your team. All programs can be customized to your specific AI systems and organizational needs.
2-Day Intensive Certification
Comprehensive certification program covering AI governance, validation, and lifecycle management in GxP environments.
- EU AI Act compliance framework
- AI validation strategies for GxP
- Model lifecycle management
- Hands-on workshops
- Certification exam
- Course materials included
Half-Day Executive Briefing
Strategic overview for leadership teams on AI governance, regulatory landscape, and organizational readiness.
- AI regulatory landscape overview
- Risk and opportunity assessment
- Governance framework essentials
- Strategic planning guidance
Lunch-and-Learn Sessions
Focused sessions on specific topics, perfect for team meetings or department training.
- Topic-specific deep dives
- Interactive Q&A format
- Practical examples
- Flexible scheduling
Custom On-Site Workshops
Tailored training programs delivered at your facility, customized to your specific AI systems and use cases.
- Customized curriculum
- Your systems and processes
- Team-based exercises
- Action plan development
Train-the-Trainer Programs
Equip your internal trainers to deliver AI compliance training across your organization.
- Comprehensive trainer materials
- Facilitation techniques
- Assessment tools
- Ongoing support access
Virtual Training Options
Live virtual sessions with the same engagement and interactivity as in-person training.
- Live instructor-led sessions
- Interactive exercises
- Breakout discussions
- Recording access
Training for Smaller Organizations
We understand that smaller biotech and pharma companies may lack dedicated AI teams or extensive resources. Our tailored programs are designed to meet you where you are.
Right-Sized Content
Training focused on your actual AI systems and use cases, not generic enterprise scenarios.
Flexible Delivery
Choose on-site, virtual, or hybrid formats that fit your team's availability and preferences.
Practical Examples
Real-world pharmaceutical and biotech examples your team can relate to and apply immediately.
Scalable Pricing
Pricing structures designed for smaller budgets without compromising on quality or depth.
Documentation Support
Templates, procedures, and documentation to demonstrate compliance to regulators and auditors.
Expert Consultation
Ongoing access to our AI compliance experts for questions that arise after training.
Training Topics
Our curriculum covers the full spectrum of AI compliance in GxP environments. Programs can be customized to focus on the areas most relevant to your organization.
Regulatory Foundations
- EU AI Act requirements and risk classification
- FDA perspectives on AI/ML in drug development
- EU GMP Annex 11 & Annex 22 (computerized systems)
- ICH guidelines relevant to AI/ML
- Global regulatory landscape comparison
AI Governance
- Building an AI governance framework
- Roles and responsibilities for AI oversight
- AI risk management methodologies
- Ethical considerations in GxP AI
- Vendor and third-party AI management
Validation & Lifecycle
- AI/ML validation strategies for GxP
- Intended use and requirement specification
- Performance qualification approaches
- Change control for AI systems
- Continuous monitoring and drift detection
Practical Implementation
- Data quality and integrity for AI
- Model explainability requirements
- Human oversight and decision-making
- Documentation and audit trails
- Incident management for AI systems
Learn From Industry Experts
Our instructors bring decades of experience from leading pharmaceutical companies, regulatory agencies, and AI development. They understand both the technology and the regulatory expectations.
Deep Expertise
Instructors with 15+ years in GxP quality and compliance
AI Specialists
Hands-on experience implementing AI in regulated environments
Practical Focus
Real-world examples and actionable guidance
Getting Started
We make it easy to bring AI compliance training to your organization.
Consultation
Discuss your AI systems and training needs
Proposal
Receive a customized training proposal
Schedule
Choose dates and delivery format
Deliver
Expert-led training for your team
Ready to prepare your team for AI compliance?
Contact us to discuss your training needs and receive a customized proposal.