ComplianceOnline

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.



COMPLEMENTARY COURSE BINDER MATERIALS (Value US$ 549.00)

  • 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:

Lunch
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.
BREAK

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.
LUNCH

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.
BREAK

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.
LUNCH

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.
BREAK

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.
ADJOURN WORKSHOP






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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