Conference Description:

Human Error Rate Program: How to Investigate, Predict, prevent, correct & recover Human Error (in the manufacturing floor and GMP)


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Dr. Ginette Collazo — a 20-year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more — will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics.

Dr. Collazo recently worked with a drug manufacturer that had a baseline rate of 4.7 errors per thousand units manufactured. But with effective human error reduction strategies, the error rate was reduced to 1.9. A 60% reduction achieved in just 10 months 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 systems weaknesses are, so they can be improved and/or fixed.

This course offers practical approaches to address human performance issues in GMP related environments by using a specific methodology to investigate, correct, prevent and avoid re-occurrence of these issues.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry.
Register now and get below documents for FREE:

RCDT - Root Cause Determination Tool
Interview Guide
HE Assessment Template
Introduction of Tools Material
Additional material



Areas Covered :

Background on Human Error Phenomena

Importance of Human Error Prevention/reduction

Training and human error

Facts about human error

Human Error as the Root Cause

What is Human Error

How is Human Error controlled?

Types of error

Human error rates and measurement

Trending and tracking

Prediction

CAPA effectiveness

Common mistakes:

Memory failures

Overconfidence

We believe we are above average

Visual Detection, Vigilance Effectiveness



Who Will Benefit:

Training managers, personnel

coordinators

Operations

Manufacturing

Plant engineering

QA/QC

Process excellence/ improvement professionals

Industrial/process engineers

Compliance officers

Regulatory/legislative affairs professionals

General/corporate counsel


AGENDA

Day 01(8:30 AM - 4:30 PM)

Lecture 1: Understanding the Basics of Human Error in Manufacturing
How human errors intersect with manufacturing regulations
Examples of applicable FDA requirements and what the FDA expects companies to be complying with
A review of other industry standards that apply to drug and device manufacturing
What FDA investigators look for during inspections and the most common violations found in Form 483s and Warning Letters
Which violations tied to human errors and manufacturing are trending up
The various types of human errors commonly found on manufacturing floors
Break
Lecture 2: Human Error and Human Factors
The taxonomy of human error; how and why drug and device companies need to focus on this in their investigation processes
Why administrative and management systems factor so prominently into deviations and nonconformance.
The role of innovative operational controls and their role in reducing human errors
When training is appropriate and when we should stop
Learn how common day-to-day communication gaps contribute to human error
How supervision can be one of the best human error reduction strategies at your site
When is individual performance responsible for human error and when does it become a root cause
How to address cognition, attention, and memory failures at your site
Lunch
Lecture 3: Psychology and Human Error
How our biology affects our thinking process and individual performance
Understanding the latest on cognitive load and attention, memory, and decision-making errors — how they commonly occur on the manufacturing floor
How our senses control how we react — it’s more important that you think
Best practices for controlling human factors for optimum people performance
How to create an organizational environment that supports human error reduction initiatives — from senior management to floor level staff
Why our culture with regards to human error has to change; it’s not an easy process but vitally necessary for drug and device companies
Break
Lecture 4: Corrective and Preventive Action (CAPA) — FDA’s #1 Manufacturing Compliance Problem
How to develop corrective actions that make sense —what’s working and not working
Creating preventive actions that truly prevent; how to stop errors that have not yet happened
Understanding the human error prediction process and tools
Prevention and human error control: proven ways to measure improvement and on-going trend analysis
When to use detection mechanisms instead of preventive mechanisms — the pros and cons of each
Human error detection and recovery rate — are you really uncovering all the errors within your facilities?
Assuring the FDA your CAPA program is effective and you’ve adequately focused on human error



Day 02(8:30 AM - 4:30 PM)

Lecture 5: Human Error Reduction Techniques
Discussion of insights from Day 1
When is human error a human resources issue?
How and when to apply engineering controls to correct and prevent human error deviations
What to do when individual performance is the major contributor
Human error and documentation: from design, construction, change management and implementation.
Additional contributors for human errors will be discussed.
Break
Lecture 6: Human Error Investigation
Human error investigation process defined from beginning to end
How to gather data in the human error investigation process
How to perform an effective interview
Important steps for effective human error investigations
How to report issues to make sure management listens
Lunch
Lecture 7: Root Cause Analysis Tools
A brief review of common tools used in determining root cause
Hierarchy and use of the root cause determination tool for human error investigations
How to perform a cognitive load assessment
The interview process and interview techniques for human error root cause analysis.
When and how to use the human error prediction tool
When to perform a process vs. procedure analysis and why it is so important to do so before establishing procedure revision as a CAPA for human error
Break
Lecture 8: Metrics and Human Error
KPI’s
Human error rate
1st time pass rate
Overall equipment effectiveness (OEE)
Trending
Tracking
Lecture 9: Review and Key Insights Materials
Copies of the presentations
Pertinent guidance documents
Articles on human error
Manual tools
Interviewing guide
Report example
Root Cause Determination Tool


SPEAKER

Ginette M Collazo
Organizational Psychologist, Ginette M Collazo Inc

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 and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.



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