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Human Error Reduction in GMP Manufacturing: Practical Strategies for Compliance and Operational Excellence
- This comprehensive training will equip you with the following skills:
- Understanding the psychology behind human error.
- Navigating regulatory requirements for human performance management.
- Applying Root Cause Analysis (RCA) effectively.
- Implementing the Root Cause Determination Tool.
- Establishing and tracking the Human Error Rate at your site.
- Developing metrics and KPIs for monitoring CAPA effectiveness.
- Integrating AI for error prediction and prevention.
- Human Error as a Root Cause: Myths vs. Reality.
- Effective Error Management and Control Mechanisms.
- Investigating and Addressing Human Error with RCA.
- Insights into Error Categorization and Near Root Causes.
- Role of Training and Environment in Human Performance.
- Error Metrics, Trending, and Prediction Tools.
- APA Strategies for Long-Term Improvement.
- Integration of ChatGPT for Enhanced Training and Decision-Making.
Overview of the webinar
If you work in a GMP-regulated industry, addressing human error deviations isn’t just about mitigating inconvenience—it’s a fundamental regulatory requirement. Across various GMP regulations globally, including FDA, EU, and ICH guidelines, ensuring that errors are identified, thoroughly investigated, and effectively addressed is a core expectation. For example, the FDA's Code of Federal Regulations (CFR) Title 21 highlights the importance of quality control units in preventing and investigating errors to safeguard product integrity and patient safety.
Human error, however, is not a root cause—it is a symptom of deeper systemic issues. These errors often stem from the design stage, encompassing gaps in procedures, inadequate training, and poorly designed workplace environments. By understanding and addressing the factors that influence human behavior, organizations can significantly reduce the likelihood of errors.
To effectively manage these challenges, it is crucial to delve into the psychology of error and establish robust processes for investigation and resolution. This course provides practical approaches and proven methodologies to address human performance issues in GMP-regulated environments, focusing on correction, prevention, and eliminating recurrences.
Who should attend?
Professionals from GMP-regulated industries including pharmaceuticals, medical devices, biologics, food, and nutrition. Job titles include:
- Training Managers and Coordinators
- Operations and Manufacturing Leads
- QA/QC Staff
- Process Improvement Specialists
- Regulatory and Compliance Officers
- Plant Engineers and Industrial Engineers
Why should you attend?
Human error is not merely a disruption in GMP manufacturing—it is a critical compliance issue under GMPs and other regulations, which mandates that all errors must be thoroughly investigated and addressed. This session will provide actionable strategies to identify, analyze, and prevent human error in regulated environments.
Key Highlights:
- Regulatory Insights: Understand how FDA requirements intersect with error management.
- Practical Solutions: Discover methods to control variables such as training, workplace design, and process improvement.
- Advanced Tools: Learn the Root Cause Determination Tool and how to integrate AI for predictive analytics.
By attending, you’ll walk away with implementable solutions and tools that elevate compliance and reduce deviations.
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.