Course Description:

Attention, memory and decision making errors are directly associated with cognition overload and mistakes. This course explores the human mind, human factors and cognitive overload in GMP related environments.

Through a combination of discussion and interactive exercises attendees will learn:

How to Perform a Cognitive Load Assessment. Participants will begin the course by learning how to perform a cognitive load assessment to reduce errors. Attendees will also be provided examples of poor human factor, engineering and workplace conditions that contribute to errors.

Human Error Reduction Techniques. Participants will be taught how and when to apply engineering controls to correct and prevent errors. Participants will work with fellow attendees to create and analyze results through the use of a box plot chart.

Human Error Investigation. Participants will be taught the proper steps to take for an effective human error investigation from beginning to end. They will be taught how to gather data when analyzing cognitive load. They will also be taught how to perform an effective interview and how to properly report issues to management in a way that they will listen

Through the use of a case study participants will conduct a full cognitive load assessment including a root cause analysis and CAPA development plan.


  • Root cause determination tool
  • Interviewing guide – you can take back and use immediately
  • Example of well-documented HE report
  • Complete copy of slide deck materials
  • Copies of applicable FDA regulations referenced in the course
  • Copies of pertinent FDA guidance documents
  • Articles focused on human error reductions

Seminar Fee Includes:

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

Who will Benefit:

  • QA/QC directors and managers
  • Process improvement/excellence professionals
  • Training directors and managers
  • Manufacturing operations directors
  • Human factors professionals
  • Plant engineering
  • Compliance officers
  • Regulatory professionals
  • Executive management

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

9:00 a.m. – 10:00 a.m.
How to perform a cognitive load assessment for human error reduction

  • Definitions and Theory
  • The regulation and human error:
  • Examples of applicable FDA requirements and what the FDA expects companies to be complying with
  • Definitions and Theory on Human Error and Cognitive Load
  • Understanding the latest on cognitive load and attention, memory, and decision making errors — how they commonly occur on the manufacturing floor
  • Cognitive Load Assessment: scenarios and applications
  • Human Errors Types and Cognitive Load
  • Human Error Cause Categories for Cognitive Load
  • How we got here — why human error reduction is such an important topic
  • Interactive Exercise: Attendees will be broken into groups and asked to describe the most common human errors related to cognition, within their facilities. The workshop will then reconvene and break-out group leaders will describe what categories were identified as root causes.

10:00 a.m. – 10:15 a.m.

10:15 a.m. – 12:00 p.m.
Cognition and Human Error

  • Human limitations on memory, attention and decision making
  • How cognitive load affects productivity
  • The various types of cognition related human errors commonly found on manufacturing floor
  • Common examples of poor human factors, engineering and workplace conditions that contribute to human error
  • When training is appropriate and when we should stop
  • When is individual performance and cognitive load 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.

1:00 p.m. – 4:30 p.m.
Cognitive Load Tool Content

  • Definition of Human Factors Categories (HFC)
  • How our senses control how we react — it’s more important that you think.
  • Importance of each HFC and latest investigation on cognition and productivity
  • Learn the Human Error Risk Multipliers and risk level
  • How to develop recommendations for each HFC
  • How to prepare for the Cognitive Load Floor Assessment
  • Workshop #1 – Floor Assessment Simulation
  • How to use the excel tool
  • Workshop # 2 – Data Entry using excel tool

8:30 a.m. – 10:00 a.m.

  • Human Error Reduction Techniques (Cognitive Load)
  • Discussion of insights from Day 1
  • Understanding the Human Error level of Risk
  • What is the level of risk and how to determine it?
  • Reporting the level of risk: tools and criticality assessment
  • Creating the Box Plot
  • Report Content
  • How and when to apply engineering
  • controls to correct and prevent human error deviations
  • What to do when individual performance is the major contributor
  • Additional contributors for human errors will be discussed

Interactive Exercise: Creating and analyzing results. Create and export the Box Plot Chart

10:00 a.m. – 10:15 a.m.

10:15 a.m. – 12:00 p.m.

  • Human Error Investigation (Cognitive Load Issues)
  • Human error investigation process defined from beginning to end
  • Individual performance: slip, mistakes and violations
  • How to gather data in the human error investigation process when analyzing cognitive load?
  • How to perform an effective interview: there’s more than meets the eye?
  • Important steps for effective human error investigations
  • How to report issues to make sure management listens?
  • When to involve Human Resources in CAPA

12:00 p.m. – 1:00 p.m.

1:00 p.m. – 2:30 p.m.
Cognitive Load Assessment- Interactive
Exercise: Full experience on Cognitive Load Assessment. A case study will be analyzed for root cause analysis, determination and CAPA development.

2:30 p.m. – 2:45 p.m.

3:00 p.m. – 4:00 p.m.

  • Writing recommendations
  • How to determine the kind of recommendation based on the type of error?
  • High and low end recommendations: benefits and challenges
  • Type of recommendations based on the type of error (random, systemic and sporadic errors)
  • How to present to management and make sure you are taken seriously

4:00 p.m. – 4:30 p.m.
Metrics and Human Error

  • KPI’s
  • Human error rate
  • 1st time pass rate
  • Overall equipment effectiveness (OEE)
  • Trending
  • Tracking
  • Closing

4:30 p.m.

Meet Your Instructor

Ginette M Collazo
Industrial/Organizational Psychologist at Ginette M. Collazo

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.

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Local Attractions

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The Washington DC region is lucky to have this wonderful historic park that offers a quick relief from hectic city life. Take the whole family for a walk and learn about the historic C & O Canal, explore the region's bike trails or spend a few hours kayaking and enjoying the breathtaking scenery.

Take a picnic and enjoy spectacular views of the Potomac River at this 800 acre park, located just 14 miles from Washington DC. Great Falls offers a variety of activities including hiking, kayaking, rock climbing, bicycling, and horseback riding.

Georgetown is the capital’s historic waterfront that today is bustling with activity. The area is a shopper’s paradise and the streets are lined with restaurants of every nationality. Take a tour of historic sites, do some shopping and enjoy a meal at a local restaurant.

Explore the U.S. Capitol Building, the White House and the U.S. Supreme Court and you will gain a fuller understanding of the division of power within our democratic government. Plan ahead and note that some tours must be scheduled in advance through your Congressional Representative.

Live theatrical productions at the John F. Kennedy Center for Performing Arts are entertainment at its finest. Purchase tickets in advance for performances ranging from musicals to concerts by the National Symphony or see a free show at the Millennium Stage.

With the recent addition of the new museum and education center, Mount Vernon is now a full day excursion. Explore the state of the art galleries and theaters, visit the 500-acre estate of George Washington and his family, tour the 14-room mansion that is beautifully restored and furnished with original objects dating back to the 1740's. Be sure to plan enough time to tour the outbuildings, including the kitchen, slave quarters, smokehouse, coach house and stables. The estate is located in Northern Virginia, just minutes from Washington, DC.

Our national monuments are truly spectacular. The best time to see them is at night when they are illuminated, less crowded and parking is easier. During daytime visits, take a tour bus. Listen to informative park ranger talks and you won’t have to negotiate congested city traffic.

Start at the Smithsonian Institution Building where you can pick up a map and information on all of the museums. These national treasures cover a wide range of subjects from art to space exploration. Plan to explore those you are most interested in, but don’t try to see everything at once. Be sure to save time to see an IMAX movie at the Natural History Museum or the National Air and Space Museum.

Listen to all types of music at this national park dedicated to the performing arts. Outdoor concerts are featured in the summer and indoor performances are held the rest of the year. The park is located in Vienna, Virginia, just 20 minutes from Washington, DC.

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