approach-to-human-error-reduction-investigations-root-cause-determination-and-capa-effectiveness

Approach to Human Error Reduction: Investigations, Root Cause Determination and CAPA Effectiveness

On Demand

  • 90 minutes
  • 0 Day Left
     Aug 20, 2019 - Aug 27, 2019
  •   08:00 AM - 09:30 AM ET
    05:00 AM - 06:30 AM PT

If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated…” That being said Human Error is NOT a root cause. Human errors start at the design stage.

Join this session by expert speaker Ginette Collazo, where she 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 industry.

Session Highlights:

  • Understand the psychology of error

  • Regulatory requirements in GMP environments for managing human performance deviations

  • Root Cause Analysis and Investigation

  • Root Cause Determination Tool

  • Establish the Human Error Rate at your site

  • Implementing the program

  • Metrics and KPI’s

  • Human Error as the Root Cause

  • What is Human Error

  • How is Human Error controlled?

  • Root Cause Determination

  • Types of error

  • Human error and training: when and where

  • Human error rates and measurement

  • Trending and tracking

  • Prediction

  • CAPA effectiveness

Why You Should Attend:

We need to be able to explain human behavior. Did the human fail because process weaknesses set them for failure? Do procedures provide for all information and clearly indicate critical steps and warning or cautions associated with steps? Do systems work for manufacturing or it the other way around? These are all tough questions to ask, but most importantly answer. This training would provide tools that can be implemented and used after this event. These include practical tools.

Who Should Attend:

  • 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


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Ginette Collazo

Ginette Collazo

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.

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

Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

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