Overview

we will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

Attention and memory failures are usually associated to cognition overload. Slips, mistakes and decision making mishaps can be predicted, prevented and reduced. In this webinar we’re going to explore the human mind, human factors and cognitive overload as it associates with human error in GMP related environments. Some items that we will discuss include stress, task complexity, available time, fatigue, and other categories. This knowledge is to be applied to risk assessment, root cause analysis and CAPA development

Webinar Takeaways

This training would provide tools that can be implemented and used after this event. These include practical tools. 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

• Know the definitions of cognitive load factors

• Learn the Human Factors (20% Individual Performance)

• Learn the questions and possible answers

• How to assess the areas

• How to collect the responses

• How to analyze the responses and determine the cognition levels

• How to report the level of risk for Human Errors

• Recommend solutions

• Human Error Categories

• Human limitations related to cognition

• Cognitive Load Categories that affect memory, attention and decision making

• How to prepare the floor assessment

• What to look for when doing the assessment

• How to present results

• How to present recommendations

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
  • Executive management

Free Handouts:

This comprehensive training program includes the following for each registered attendee:

• A copy of the presentation slides

• A certificate of participation for attendee training records

• Q/A Session

• All the handouts given by the course Instructor.

Industries who can attend

This 90 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Faculty Ginette Collazo, Ph. D



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.

FDA Speaker, Ginette Collazo

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