Latest Trends in Human Error Reduction in GMP Manufacturing: Strategies for Compliance and Operational Excellence
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes
Webinar Id:
54318
More Trainings by this Expert
Price Details
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Overview:
GMP-Regulated Manufacturing (Pharma, Biologics, Medical Devices, Food & Nutrition).
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.
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
Key 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 in the Session:
- 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)
Who Will Benefit:
- 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 Profile
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.
She 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.
