Description

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. From procedures, training, and workplace environment many variables that affect human behavior CAN be controlled reducing the likelihood of these occurrences.

To work with these challenges, it is essential to understand human behavior and the psychology of error as well as implementing a process exclusively dedicated to investigating and “fixing” these problems. 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 reoccurrence of these matters.

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. 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.

Webinar Takeaway

  • 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

Who Will Benefit

  • 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

Faculty Ginette Collazo

CEO Human Error Solutions

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience specializing 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 (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

1.5 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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