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 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
How to Write Contracts for Procurement Professionals
Sunshine Act Reporting - Clarification for Clinical Research
How to Deal with Employees Who Love to Argue and Debate Eve…
Project Management for administrative professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Terminating Toxicity: Strategies For Leaders To Confidently…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Reprogramming your mind for Corporate Excellence: 4 Steps t…
How to Write Effective Audit Observations: The Principles f…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Uplifting the Credibility of HR: How to Build the Credibili…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Bridging Generational Divides in the Workplace
Strategic Interviewing & Selection: Getting the Right Talen…
Onboarding Best Practices for Millennial and All Employees
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
FDA Audit Best Practices - Do's and Don'ts
Emotional Intelligence: Mastering the Emotions of Great Lea…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Accounting For Non Accountants : Debit, Credits And Financi…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Developing and Implementing Quality Culture in the Organiza…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Break Free from Toxicity: Reclaim Your Power and Peace
Tips and Techniques for Conducting an Effective Fraud Risk …
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Navigating 2025 Employment Laws: What Every Employer Needs …
Implementing an Effective Human Error Reduction Program
Cleaning Data without Complex Functions - A Course for Data…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Principles & Practices for the Cybersecurity of Legacy Medi…