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Description
In today’s evolving GMP landscape, staying ahead of human error trends is critical. This webinar addresses cutting-edge strategies for managing human error as a systemic challenge—not just a behavioral issue. Gain insight into how the latest tools, including AI and predictive analytics, are reshaping compliance, training, and error prevention across regulated industries.
Learning Objectives
Participants will learn how to:
- Analyze the psychology behind modern human error patterns.
- Align with evolving FDA, EU, and ICH compliance standards.
- Conduct advanced Root Cause Analysis (RCA) with updated tools.
- Use the Root Cause Determination Tool to uncover systemic issues.
- Monitor Human Error Rate (HER) trends with smart metrics.
- Measure CAPA effectiveness using real-time KPIs.
- Integrate AI and tools like ChatGPT into training and prevention programs.
- Current Statistics.
Areas Covered
- Modern Misconceptions: Human Error as a Root Cause
- Emerging Tools for Error Detection and Control
- Advanced RCA for Human Error Management
- Latest Thinking on Error Categorization and Behavioral Drivers
- Workplace Design, Training, and Human Factors
- Predictive Metrics: Trending, Monitoring & Forecasting Errors
- Data-Driven CAPA Systems
- AI-Powered Training and Human Decision Support (ChatGPT Use Cases).
Why Should You Attend
- Discover how modern GMPs are reshaping expectations around human error.
- Learn regulatory trends and emerging enforcement patterns from agencies like the FDA.
- Use AI and digital tools to forecast and prevent deviations.
- Upgrade your CAPA strategies using performance metrics and behavioral data.
- Leave with actionable insights and methodologies to drive long-term compliance improvements.
Who Should Attend
Professionals in GMP-regulated industries, including:
- Pharmaceuticals
- Medical Devices
- Biologics
- Food and Nutrition.
Relevant Roles:
- QA/QC Managers and Specialists
- Training and HR Coordinators
- Manufacturing and Operations Managers
- Regulatory Affairs Officers
- Process Improvement Engineers
- Industrial/Plant Engineers.
Speaker
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with over 20 years of experience specializing in Engineering Psychology and Human Reliability.
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 training and consulting firm, and 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. As a GMP expert, she has also been a Keynote Speaker at significant events worldwide.
Ginette Collazo, Ph. D., is the author of several books, “Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.”
In 2023, Human Error Solutions was named as a top ten industrial service provider by Manufacturing Outlook magazine and featured in ABC, Fox, NBC, and CBS news.
She hosts The Power of Why Podcast—a show about human behavior in the workplace and critical thinking.