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
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…