Webinar Takeaway

Module 1 Supervising a Human Error Free Environment: You can do a Lot More than you Think

Session Highlights

• Background on Human Error Phenomena

• What is Human Error

• Importance of Human Error Prevention/reduction

• Supervision and human error

• Facts about human error caused by supervisors and how to avoid it

• When operator error is the Root Cause?

• How is Human Error controlled by supervision?

• Common mistakes: Memory failures, Overconfidence, Visual Detection, and Vigilance Effectiveness and how supervision can help improve these

• Types of error

• Human error rates and measurement

• Trending and tracking

• Prediction

• CAPA Effectiveness

Module 2– How to write SOP's that Avoid Human Error

Session Highlights

• SOP writing outline

• Content development

• The rationale for procedure use

• Regulatory compliance background

• Universal purpose of procedures

• The Human Perspective

• Human Error as a root cause

• The thinking and reading process

• Common mistakes and causes

• How to create and maintain a procedure

• Goals of a procedure

• Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions,”

• Procedure styles

• Use of electronic information networks for procedure access.

Module 3 Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Session Highlights

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

Module 4 How to Deploy Root Cause & CAPA to Minimize Human Error

• Determine what is a causal factor of quality and compliance issues, as established in GMPs

• Gain better control over non-conformances by incorporating a failure investigation system and root cause analysis / risk management / human factors in our process, procedures and systems

• Understand the types of normal usage and system failures, including intentional and unintentional errors of omission and commission in FI and RCA

• Use basic statistical tools in harmony with the CGMPs to locate, identify and reduce / eliminate problems and root causes. using the root cause determination tool, and cognitive load tool

• Track non-conformance trends in quality and compliance

• Make predictions regarding potential non-conformances using ISO 14971 and ICD Q9 tools, diagnostic studies and FI/RCA tools

• Determine CAPA effectiveness by event reoccurrence and root cause recurrence

Who Will Benefit

  • Training managers and coordinators
  • Operations
  • Manufacturing
  • Plant engineering
  • QA/QC staff
  • Process excellence/improvement professionals
  • Industrial/process engineers
  • Compliance officer
  • Regulatory/legislative affairs professionals
  • General/corporate counsel

Industries who can attend

This 360 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Ginette M. Collazo


DR. Ginette M. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, 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.

Faculty Ginette M. Collazo

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