Human Error Trends as AI Enters GMP Operations: What QA Leaders Should Expect and Monitor
Register Now- Current FDA expectations for AI-enabled GMP operations
- AI governance and organizational accountability
- Validation and lifecycle management for AI applications
- Human oversight of AI-supported quality decisions
- Managing bias, hallucinations, model drift, and data integrity
- AI applications across CAPA, deviations, complaints, and training
- Inspection readiness and documentation practices
Organizations introducing AI into GMP operations must understand how human performance expectations change as automated support becomes part of routine quality decisions.
This session structures practical approaches for AI governance, human oversight, risk management, and quality system controls that support reliable GMP operations.
The session examines how existing GMP expectations apply as AI becomes integrated into quality systems, then connects governance, validation, human oversight, and operational monitoring into a practical framework for inspection readiness. Throughout, emphasis remains on maintaining accountability while adapting quality practices to AI-assisted environments.
Dr. Ginette Collazo combines more than 20 years of experience in industrial-organizational psychology with extensive work supporting GMP-regulated industries through quality systems, human performance, compliance, and AI governance. Her focus on human decision-making, operational performance, and quality culture provides practical insight into how organizations can integrate AI while maintaining effective oversight and regulatory compliance.