Next-Gen Human Error Prevention in GMP: 2025–2026 Tools & Trends

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

Relevant Roles:

QA/QC teams, Training and HR Specialists, Manufacturing/Operations Leaders,

Regulatory Affairs Officers, Process Improvement Engineers, Plant/Industrial

Engineers.

Speaker Profile:

Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with over 20

years of specialized experience in Engineering Psychology and Human Reliability.

She has led human reliability and training programs in global pharmaceutical and

medical device organizations.

In 2009, she founded Human Error Solutions (HES), now recognized as a global

leader in human error reduction. Her scientifically validated methodology for error

investigation, cause determination, CAPA development, and system-level prevention

has been implemented in industries worldwide.

Dr. Collazo is the author of Human Error: Root Cause Determination Model and

Mission Matters. She has been featured on ABC, FOX, NBC, and CBS, and in 2023,

HES was named a top ten industrial service provider by Manufacturing Outlook

Magazine. She also hosts The Power of Why Podcast, focused on human

behavior, performance, and critical thinking.

After Registration:
Once you register, you’ll receive a confirmation email with your login credentials and access to downloadable presentation materials. These resources can also be shared with your team for internal training and reference.

System Requirements:
Internet: A stable internet connection of at least 1 MBPS is recommended for a smooth experience.
Audio: Use a working headset or speaker with a microphone for clear audio, especially during interactive sessions.

Session Cancellation Policy:
If a session must be cancelled or rescheduled, WebinarWaves will notify all registered participants via email no later than 24 hours before the scheduled start time.

Can’t Attend the Live Webinar?
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Email: cs@webinarwaves.com
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What Attendees Are Saying:

In pharma, compliance is always top of mind, and this webinar really delivered. The strategies were practical, and I could immediately see how to apply them in our documentation work. - Rachel Morgan, Quality Assurance Specialist at a Biopharma Company

I really enjoyed this webinar! The content was spot-on for anyone handling

medical affairs. The examples shared made it easy to follow, and I walked away

with actionable tips I can use right away. Good Job Webinar Waves. - Robert Johnson, Medical Affairs Manager

Valuable webinar! Provided valuable insight into how logistics risks are defined,

managed, and communicated within the pharmaceutical sector. - Michael Torres, Supply Chain Manager

Clear and informative session. Everything about compliance and regulations

was explained in a way that actually makes sense. - Mei Lin, Regulatory Affairs Specialist