- Date: May 12 - 13, 2026
- Location: San Diego, California
Driving the 5.0 Evolution of Manufacturing, Validation, and Beyond
AI in GxP 2026 delivers practical, hands-on strategies for applying artificial intelligence across the core pillars of regulated life-science operations – validation, quality systems, manufacturing, engineering, facilities, automation, and IT. The program focuses on how real teams are using AI today to streamline processes, strengthen compliance, improve reliability, reduce manual effort, and accelerate decision-making across essential GxP activities. Designed for practitioners, this event emphasizes tangible examples, proven methods, and actionable tools that modernize day-to-day operations as organizations advance toward the 5.0 era.
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Building on this foundation, the agenda extends into high-impact areas such as supply chain, labeling, batch records, clinical operations, tech transfer, and R&D – demonstrating how AI supports smarter decisions across the full product lifecycle. Sessions are designed to show how AI can be scaled responsibly and compliantly while increasing operational efficiency and cross-functional alignment.
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Top 10 AI in GxP Challenges andOpportunities Life Science Leaders are Exploring IN 2026
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What You’ll Learn
- How AI enhances manufacturing performance, MES oversight, batch execution, and shop-floor visibility
- How engineering and facilities teams use AI for predictive maintenance, reliability modeling, sensors, and process control
- AI-driven approaches to environmental monitoring, contamination trending, and digital cleaning validation
- How IT and automation groups validate and secure cloud, SaaS, cybersecurity, networks, and digital infrastructure
- Risk-based methods for validating AI/ML models within CSV/CSA frameworks.
- AI-enabled improvements to quality processes including documentation, training, deviations, CAPA, and continuous improvement
- How AI supports supply chain planning, labeling accuracy, batch record automation, and tech transfer
- Opportunities for AI in clinical operations, discovery, and R&D decision-making
- Governance models for transparency, traceability, and responsible AI oversight
- Regulatory expectations from FDA, EMA, MHRA, Annex 11/22, and emerging global guidance
Special Features
- Case studies illustrating AI adoption across manufacturing, quality, engineering, facilities, supply chain, and IT
- Walkthroughs of AI-enabled validation packages, documentation updates, and practical risk tools
- Sessions on predictive maintenance, sensor analytics, and engineering reliability models
- AI-driven environmental monitoring, contamination trending, and facility-control optimization
- Digital cleaning validation, automated MACO calculations, and intelligent risk detection
- Applied AI for MES insights, batch execution review, batch records, and automation systems
- AI applications in labeling, supply chain integrity, tech transfer, clinical operations, and R&D
- IT-focused sessions on cloud validation, cybersecurity, data integrity, and digital infrastructure assurance
- Templates, checklists, and tools that teams can deploy immediately across GxP operations
Who Should Attend
- Manufacturing, Facilities, and Operations Professionals
- Engineering, Reliability, and Automation Teams
- IT, Cybersecurity, Cloud, and Digital Infrastructure Leaders
- Quality, Documentation, and Data Integrity Specialists
- Validation, CSV/CSA, and Compliance Professionals
- Supply Chain, Labeling, and Batch Record Teams
- Clinical Operations, R&D, and Tech Transfer Staff
- System Owners, Process Leads, and Project Managers
- Anyone implementing, supporting, or validating AI-enabled GxP systems
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