How to Reduce Human Error in a GMP Manufacturing Floor

Human error continues to be one of the leading causes of deviations, non-conformances, and regulatory citations in GMP-regulated environments. But here's the truth: human error is rarely the true root cause—it often points to deeper flaws in systems, processes, training, or design. This webinar dives into the psychology of human error and offers practical, actionable frameworks for preventing it. Learn how to redesign systems, improve documentation and training, and build a culture of quality that aligns with 21 CFR Part 211 requirements. If you're responsible for operational compliance or quality assurance in a pharmaceutical or life sciences organization, this is a must-attend session.

• Understand why human error is rarely the true root cause in deviation investigations.
• Learn how to align error reduction strategies with 21 CFR Part 211.22 and FDA expectations.
• Explore types of human error and how to classify, measure, and trend them.
• Gain insights into human behavior, cognitive load, and error-prone systems.
• Improve CAPA effectiveness with targeted error prevention strategies.
• Learn how to evaluate procedures, training effectiveness, and environmental influences.
• Integrate digital tools like ChatGPT to enhance root cause investigations and predictive tracking.

• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Root Cause Determination
• Types of error
• Human error and training: when and where
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness
• ChatGPT Integration

Human errors are not just frustrating—they’re expensive, non-compliant, and largely preventable. This session addresses the silent system flaws that often set personnel up for failure. We'll explore critical questions: Are your SOPs clear and actionable? Is your training tailored to real-world challenges? Does your environment support or sabotage performance? This webinar will help you identify hidden root causes and provide ready-to-use tools to reduce repeat deviations and CAPA recurrence. It's not just about fixing errors—it's about designing operations where errors are unlikely to happen in the first place.

• Quality Assurance Teams
• Quality Control Teams 
• Manufacturing & Operations Teams
• Training Managers & Coordinators
• Compliance & Regulatory Affairs Professionals
• Plant & Process Engineers
• Continuous Improvement / Process Excellence Teams
• Legal and Corporate Counsel in regulated environments

Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.