This course offers practical approaches and models to address human performance issues in GMP-related environments by using a specific methodology to correct, prevent and avoid the re-occurrence of these issues.
WHY SHOULD YOU ATTEND?
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior can be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are, so they can be improved and/or fixed.
This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss human error categories, near root causes, and root causes for these events. We will discuss the latest trends in human error issues in the industry.
AREA COVERED
- Background on human error phenomena
- Importance of human error prevention/reduction
- Training and human error
- Facts about human error
- Human error is the root cause
- What is human error
- How is human error controlled?
- Common mistakes: Memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectiveness
- Types of error
- Human error rates and measurement
- Trending and tracking
- Prediction
- CAPA effectiveness
LEARNING OBJECTIVES
- Understand human error: factors and causes
- Understand the importance: of regulatory and business
- Define the process to manage Human Error deviations
- Identify Root Causes associated with human error deviations
- Learn how to measure human error rates at your site
- Identify what I can do to support human reliability
WHO WILL BENEFIT?
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior can be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are, so they can be improved and/or fixed.
This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss human error categories, near root causes, and root causes for these events. We will discuss the latest trends in human error issues in the industry.
- Background on human error phenomena
- Importance of human error prevention/reduction
- Training and human error
- Facts about human error
- Human error is the root cause
- What is human error
- How is human error controlled?
- Common mistakes: Memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectiveness
- Types of error
- Human error rates and measurement
- Trending and tracking
- Prediction
- CAPA effectiveness
- Understand human error: factors and causes
- Understand the importance: of regulatory and business
- Define the process to manage Human Error deviations
- Identify Root Causes associated with human error deviations
- Learn how to measure human error rates at your site
- Identify what I can do to support human reliability
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
Speaker Profile
Ginette M. Collazo
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 …
Upcoming Webinars
AI for Project Managers: Smarter Planning Reporting and Com…
Mastering Performance Management: Strategies for Continuous…
ChatGPT for Innovative Business Advisory Services for Accou…
Female to Female Hostility @Workplace: All you Need to Know
Latest Trends in Human Error Reduction in GMP Manufacturing
Bootcamp for New Managers and Supervisors: Develop These Es…
Analytical Method Validation Under Good Laboratory Practice…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Data Integrity and Privacy - Compliance with 21 CFR Part 11…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Payroll Record Keeping: How to Thin Out File Cabinets and Q…
Medical Device Cybersecurity Following FDA’s 2026 Premarket…
Construction Lending And Real Credit Administration: Evalua…
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Moving From an Operational Manager to a Strategic Leader
Launch Your Career: The Ultimate Guide for Emerging Profess…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Discover how Emotional Intelligence turns AI from a technic…
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
The 60 Minutes Introduction to DAX
Empowering Conflict Resolution: Letting Go to Gain Control
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…