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 you should 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