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Reduce Human Error on the Drug and Device Manufacturing Processes(WCS)

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Hilton East Brunswick

3 Tower Center Blvd

East Brunswick, NJ 08816

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This interactive workshop teaches you how to reduce your manufacturing error rates by 50%.

Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

Dr. Ginette Collazo — a 15 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.

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

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

Learning Objectives

Free documents for Attendee

  1. RCDT – Root Cause Determination Tool
  2. Interview Guide
  3. HE Assessment Template
  4. Introduction of Tools Material
  5. 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.

Course Outline:

DaY ONE (08:30 AM ? 05:00 PM)

8:00 a.m. – 8:30 a.m Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

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

  • Interactive Exercise! Do we also err? Attendees will be broken into groups and asked to describe the most common human errors within their facilities. The workshop will then reconvene and break-out group leaders will describe what they uncovered. A list of the most common problems will be tallied to help focus the future discussion

10:00 a.m. – 10:15 a.m.Break

10:15 a.m. – 12:00 p.m

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
  • Simple procedures that prevent human error -- how they should be described and presented to maximize human error reduction
  • Common examples of poor human factors engineering and workplace conditions that contribute to human error
  • 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

12:00 p.m. – 1:00 p.m. Lunch

1:00 p.m. – 2:30 p.m.

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

2:30 p.m. – 4:30 p.m.

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 for the FDA your CAPA program is effective and you’ve adequately focused on human error
-Interactive Exercise! When to do what?

DaY TWO (08:30 AM - 05:00 PM)

8:30 a.m. – 10:00 a.m.

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.
Interactive Exercise! Practice identifying techniques to be applied

10:00 a.m. – 10:15 a.m.Break

10:15 a.m. – 12:00 p.m.

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

12:00 p.m. – 1:00 p.m. Lunch

1:00 p.m. – 2:30 p.m.

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.
-Interactive Exercise! Brainstorm root causes for real cases with peers. -Using the situations identified in the first exercise we will try and apply the applicable tool.

2:30 p.m. – 2:45 p.m. Break

2:45 p.m. – 4:45 p.m.

Metrics and Human Error

Human Error rate
1st time pass rate
Overall equipment effectiveness (OEE)
Interactive Exercise! Discuss group discussion

4:45 p.m. – 5:00 p.m.

Review and Key Insights Materials

Copies of the presentations
Current FDA regulations
Pertinent guidance documents
Articles on Human Error
Manual Tools
Interviewing guide
Report Example
Root Cause Determination Tool

5:00 p.m. Workshop End


Ginette M. CollazoPHD

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.

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(a)
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

This Event Listing is Promoted by
New York Media Technologies LLC in association
with WCS Consulting Inc.

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Hilton East Brunswick

3 Tower Center Blvd

East Brunswick, NJ 08816

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