Training Overview

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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 essential to understand what is human error, how to comprehend human behavior, and the psychology of error. It is also important to understand the root cause of errors and exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP-related environments by using a particular methodology to correct, prevent and avoid the reoccurrence of these matters.

Why should You Attend

This training would provide tools that can be implemented and used for human error prevention. These include practical tools and tips on how to control human error. We will discuss human error categories, near root causes, and root causes for these events. We will discuss the latest trends in human error issues in the manufacturing industry.

Webinar Takeaway

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

90 minutes

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

90 minutes

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

90 minutes

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

90 minutes

• 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

Faculty Ginette M. Collazo

Ginette M. Collazo (30+ year exp.)

CEO Human Error Solutions

Miami, Florida, United States

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines 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.

More than ten years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, root cause determination, CA-PA development, and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied to critical quality situations and workplace accidents.

Choose a Purchase Options

Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

Learn More