This two-day seminar in Los Angeles from October 6-7th will address how to reduce, investigate, correct, and prevent human error in manufacturing processes. The seminar leader, Dr. Ginette Collazo, is an expert in human error and behavior with over 15 years of experience working with major pharmaceutical companies. On the first day, attendees will learn about the basics of human error and factors that can drive errors. The second day will cover corrective and preventive action, human error reduction techniques, investigation processes, and use of tools to analyze root causes. The seminar aims to provide practical approaches for addressing human performance issues in regulated environments.

1. Seminar 1 : OCTOBER 06TH
-07TH
2016 || Location : Los Angeles
2 Day Seminar
How to reduce, investigate, correct, and prevent
Human Error in Manufacturing Processes
$896 For Each Attendee Limited Seats Left Special Group Discount For Four Attendees $2995
GINETTE COLLAZO, PH.D
is a human error and human
behavior expert. She has
Spent more than 15 years in
technical training,
organizational development
and human
Reliability areas. She has
worked with Bristol-Myers
Squibb, Johnson & Johnson,
Schering-Plough, Wyeth, and
has been a consultant with
major firms like Abbott,
Johnson & Johnson, Perrigo,
among many others. Also
has implemented human
error
Reduction programs and
technology in many more
small and mid-sized drug and
Device companies. An active
researcher in specialized
studies related to human
Reliability, she is the author of
numerous publications on
these topics.
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.
DAVID JONES (954-947-5670)
WWW.WORLDCOMPLIANCESEMINARS.COM

2. Each attendee will receive 2 Day workshop materials by the speaker
Seminar Also Includes Certificate, Complimentary Breakfast, Lunch &
High Tea/Coffee provided by WCS
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?
 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
 RCDT – Root Cause Determination Tool
 Interview Guide
 HE Assessment Template
 Introduction of Tools Material
 Additional material
 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.
Who will Benefit?
 Training managers
and coordinators
 Operations
 Manufacturing
 Plant engineering
 QA/QC staff
 Process
excellence/improvem
ent professionals
 Industrial/process
engineers
 Compliance officers
 Regulatory/legislative
affairs professionals
 General/corporate
counsel
DAVID JONES (954-947-5670)
WWW.WORLDCOMPLIANCESEMINARS.COM

3. DAY ONE (08:30 AM ? 05:00 PM)
Understanding the Basics of Human Error on the Manufacturing Floor
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 are commonly found on manufacturing floors
 How we got here — why is human error reduction such an important topic
Human Error In Context — What Are the Factors That Drive Human Errors?
 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 non-
conformances
 The role of innovative operational controls and their role in reducing human errors
Internal vs. External Factors
 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
DAVID JONES (954-947-5670)
WWW.WORLDCOMPLIANCESEMINARS.COM

4. i
i
Seminar 1 : July 28-29, San Francisco CA
Seminar 2 : Dec 01-02, San Francisco CA
DAY TWO (08:30 AM ? 05:00 PM)
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-go in 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 for the FDA your CAPA program is effective and you’ve adequately focused on human error
Interactive Exercise! When to do what?
Human Error Reduction Techniques
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
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 foe effective human error investigation
How to report issues to make sure management listens
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
Metrics and Human Error
KPI’s
Human Error rate, 1st time pass rate, Overall equipment effectiveness (OEE), Trending /Tracking
Location
Seminar 1: Los Angeles
October 06th
-07th
DAVID JONES (954-947-5670)
WWW.WORLDCOMPLIANCESEMINARS.COM