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ChatGPT and Human Error: Reducing Risk and Enhancing Decision-Making
- Human Error in Regulated Environments
- Overview of ChatGPT and Generative AI
- Human Factors and AI: Cognitive Load, Memory, and Distraction
- Use Cases: SOP Simplification, Decision Support, Training Aids
- Prompt Engineering for Clarity and Compliance
- Regulatory Risks and Mitigation Strategies
- AI Usage SOPs and Internal Governance
- Ethical and Practical Limits of AI in Manufacturing
- Identify where human error stems from in complex environments
- Understand the capabilities and limitations of ChatGPT
- Use ChatGPT to improve SOP clarity and reduce ambiguity
- Apply prompting techniques for effective use
- Implement AI support tools while maintaining compliance with FDA and EU regulations
- Design an AI usage SOP aligned with 21 CFR Part 11 and ALCOA+
- Establish safeguards for using AI tools in error-prone processes
Overview of the webinar
Artificial intelligence is transforming how we work, especially in highly regulated environments where human error can compromise product integrity, compliance, and patient safety. While human error is often treated as an individual failing, it is usually the result of systemic weaknesses, like poorly written procedures, high cognitive load, or insufficient training. This session explores how generative AI tools such as ChatGPT can support human reliability efforts by reducing cognitive demand, enhancing decision-making, and reinforcing clarity in SOPs and work instructions.
Participants will gain a foundational understanding of AI's capabilities, limitations, and regulatory considerations in GMP settings. Most importantly, this session emphasizes how to integrate AI without compromising data integrity, compliance, or operational discipline.
Who should attend?
- QA/QC Personnel
- Compliance Officers
- Manufacturing and Operations Leaders
- Training Coordinators
- Industrial Engineers
- Documentation Specialists
- Process Analysts and Continuous Improvement Professionals
Why should you attend?
This training offers professionals in GMP-regulated industries the opportunity to understand how AI tools—when used responsible can enhance human performance and reduce common failure modes. ChatGPT and similar technologies, when applied properly, can support clarity, reduce ambiguity, and improve training without replacing compliance oversight or validated systems. The session bridges the gap between traditional error reduction strategies and emerging AI tools.
Key Highlights
- How ChatGPT helps simplify procedures and training materials
- When and how AI can support decision-making without replacing human judgment
- Regulatory implications of AI use in GMP environments
- Creating a governance model for AI usage
- Hands-on examples of safe, compliant ChatGPT use
- Tools to improve cognitive ergonomics and reduce error-inducing complexity
Faculty - Dr.Ginette Collazo
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines 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.
In 2009, Dr. Collazo established Human Error Solutions (HES), a US-based boutique consulting firm. She has positioned herself as one of the few Human Error Reduction Experts worldwide. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness implemented and proven amongst different industries globally. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. A GMP expert also has a Keynote Speaker at significant events worldwide.
Ginette Collazo, Ph. D., is the author of several books, “Including Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.”
Also, she is the host of The Power of Why Podcast. A show about human behavior in the workplace and critical thinking.