Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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 essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP-related environments by using a particular methodology to correct, prevent, and avoid reoccurrence of these matters.
WHY SHOULD YOU ATTEND?
This training would provide tools that can be implemented and used after this event. These include 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
- Human Error as the Root Cause
 - What is Human Error
 - How is Human Error controlled?
 - Root Cause Determination
 - The 6-step method for error prevention
 - Human error rates and measurement
 - Trending and tracking
 - Prediction
 - CAPA effectiveness
 
LEARNING OBJECTIVES
- Error Reduction System
 - HES Tools
 - Cognitive load tool
 - Definition of Human Factors Categories (HFC)
 - Importance of each HFC
 - Learn the Human Error Risk Multipliers
 - Recommendations for each HFC
 - Implementing the program
 - Metrics and KPIs
 
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
 
This training would provide tools that can be implemented and used after this event. These include 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.
- Human Error as the Root Cause
 - What is Human Error
 - How is Human Error controlled?
 - Root Cause Determination
 - The 6-step method for error prevention
 - Human error rates and measurement
 - Trending and tracking
 - Prediction
 - CAPA effectiveness
 
- Error Reduction System
 - HES Tools
 - Cognitive load tool
 - Definition of Human Factors Categories (HFC)
 - Importance of each HFC
 - Learn the Human Error Risk Multipliers
 - Recommendations for each HFC
 - Implementing the program
 - Metrics and KPIs
 
- 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
                                    
                                Empowering Conflict Resolution: Letting Go to Gain Control
                                    
                                Developing an Agile Workforce with Emotional Intelligence (…
                                    
                                FDA Regulation of Artificial Intelligence/ Machine Learning
                                    
                                Compliance Under Fire: Navigating I9 Immigration Raids & …
                                    
                                
                                    
                                How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
                                    
                                
                                    
                                Human Error Reduction Techniques for Floor Supervisors
                                    
                                How To Conduct An Internal Harassment And Bullying Investig…
                                    
                                Secrets Of Psychology - Why People Do The Things They Do
                                    
                                FDA Compliance And Laboratory Computer System Validation
                                    
                                Leadership: Strategic Planning and Decision Making
                                    
                                Polish your Presence on Linkedin - The Powerful Profile
                                    
                                Marketing to Medicare or Medicaid Beneficiaries - What You …
                                    
                                Human Factors Usability Studies Following ISO 62366 and FDA…
                                    
                                Leveraging Artificial Intelligence in HR
                                    
                                Bootcamp for New Managers and Supervisors: Develop These Es…
                                    
                                
                                    
                                Utilizing A Proven Process When Conducting Sensitive, Inter…
                                    
                                Understand the Different Contexts in DAX, The Filter Contex…
                                    
                                Understanding and Analyzing Financial Statements
                                    
                                HR Metrics and Analytics 2025 - Update on Strategic Plannin…
                                    
                                The Importance of Storytelling in Project Management
                                    
                                Defensive Documentation: Protecting Your Organization from …
                                    
                                Topic Name/Course Title Leading a Project and Team in Stres…
                                    
                                Power Bi - Turn Bad Data Into Great Data In Minutes
                                    
                                OSHA Reporting: What are OSHA's Reporting Requirements?
                                    
                                Onboarding is NOT Orientation - How to Improve the New Empl…
                                    
                                Copilot and HR: An Introduction for HR Professionals
                                    
                                
                                    
                                
                                    
                                Establishing Appropriate Quality Metrics and Key Performanc…
                                    
                                How to Write Effective Audit Observations: The Principles f…
                                    
                                Basic Accounting and Finance for Human Resources Profession…
                                    
                                
                                    
                                EBIT/EBITDA - Understanding Your Profit and Loss Statement-…
                                    
                                FDA Audit Best Practices - Do's and Don'ts
                                    
                                Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
                                    
                                FDA Technology Modernization Action Plan (TMAP) and Impact …
                                    
                                Stress, Change And Team Resilience Through Humor: An Intera…
                                    
                                
                                    
                                Controller Challenges in Changing Times: New Roles as Strat…
                                    
                                
                                    
                                The Importance of the first 5 seconds when presenting
                                    
                                Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
                                    
                                
                                    
                                Sunshine Act Reporting - Clarification for Clinical Research
                                    
                                How to Prepare For and Host a FDA Inspection and Respond to…
                                    
                                From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
                                    
                                Managing Toxic Employees: Strategies For Leaders To Effecti…