Next-Generation Human Error Prevention in GMP Manufacturing- 2025–2026 Trends, Tools and Compliance Strategies

Description

As GMP environments evolve, human error is no longer viewed as a simple behavioral lapse—it is now recognized as a system-driven challenge requiring modern, data-informed solutions. This session explores the latest strategies, technologies, and regulatory expectations shaping human error management across pharmaceutical, medical device, biologics, and food industries. Discover how AI, predictive analytics, and advanced RCA tools are transforming compliance and operational performance.

Learning Objectives

Participants will learn how to:

• Understand the psychology behind today’s most common human error patterns.
• Stay aligned with evolving FDA, EU, and ICH regulatory expectations.
• Apply advanced Root Cause Analysis (RCA) methodologies.
• Use the updated Root Cause Determination Tool to uncover system-level contributors.
• Track Human Error Rate (HER) trends with meaningful, predictive metrics.
• Measure CAPA effectiveness through actionable KPIs.
• Integrate AI—including platforms like ChatGPT—into training and error prevention processes.
• Examine current industry statistics shaping error-reduction strategies.

Areas Covered in the Session

• Modern misconceptions about human error as a root cause
• New and emerging tools for error detection and control
• Advanced RCA approaches for human error events
• Updated thinking on error types, behavioral drivers, and human factors
• Workplace design, training effectiveness, and system engineering
• Predictive trending, monitoring, and forecasting of error patterns
• Data-driven CAPA programs for long-term improvement
• AI-powered training and human decision-support applications

Why You Should Attend

• Understand how modern GMP expectations are reshaping human error compliance.
• Identify key regulatory trends influencing FDA and global enforcement.
• Learn how AI and digital systems can prevent deviations before they occur.
• Strengthen CAPA programs using real-time performance indicators and behavioral data.
• Gain actionable techniques and frameworks to elevate operational reliability and compliance.

Who Will Benefit

Ideal for professionals in:

• Pharmaceuticals
• Medical Devices
• Biologics
• Food & Nutrition