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 1. Eventura World
 2. Courses
 3. 3-HOUR VIRTUAL SEMINAR ON HUMAN ERROR PREVENTION IN THE LIFE SCIENCES


3-HOUR VIRTUAL SEMINAR ON HUMAN ERROR PREVENTION IN THE LIFE SCIENCES

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FACULTY: CHARLES PAUL

Scheduled Date : May 09 2022

Scheduled Time : 1pm -  4pm ET



Description

This 3-Hour virtual seminar will explore the true causes and nature of human
error, how human error should be investigated, how human error relates to human
performance, and the difference between real human error and systems, process,
and management deficiencies. It will also address how human error occurs in the
planning and execution stages of task performance.

Human Error occurs in all settings. In the world of pharmaceutical
manufacturing, the result of that error can result in loss of product or at the
most extreme, injury to patients. Human is a frequent occurrance in
pharmaceutical manufacturing. It occurs even when every obvious preventive
actions have been employed such as effective compliance documentation
development and training.

Unfortunately, sometimes these actions are not adequate to prevent these errors
from occurring. “Human Error” is sometimes not the cause of issues even though
relegated / assigned as the root cause of adverse events with reasons assigned
such as “lack of attention to detail” or “failure to follow procedure”.
Corrective action in these instances often involve re-training or disciplinary
action. These approaches do not seek to understand really why the error(s)
occurred.

Learning Objectives:

At the completion of this webinar participants will be able to:

 * Define human error and identify its properties.
 * Explain the cost of human error
 * Explain how human error is manifest in the pharmaceutical setting
 * Explain how potential human error situations are investigated
 * Explain how the real root cause of human error is identified and verified.  
 * Define the role of leadership in Human Error reduction
 * Explain and describe the Error Reduction Strategies that are effective in
   mitigating human

Seminar Agenda :

 * Human error defined
 * Properties of human error
 * When does human error occur
 * Human error and human performance
 * Human error in pharmaceutical manufacturing
 * The role SOPs and Work Instructions play in preventing Human Error
 * Investigating human error
 * Determining and verifying human error root causes
 * The role of leadership in Human Error reduction
 * Human Error Reduction Strategies
 * Human Error Prevention and Reduction Drivers

Who Should Attend : 

 * Regulatory Affairs Departments
 * Compliance Departments
 * Quality Departments
 * Manufacturing Departments
 * Production Departments
 * Engineering Departments
 * Operations Departments
 * Research and Development Departments
 * Documentation Departments
 * Laboratory Professionals






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FDA Human Error Charles Paul CAPA
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COMPUTER SYSTEM VALIDATION (CSV) AND DATA INTEGRITY FOR CLINICAL TRIALS
REGULATED BY FDA
GLP LABORATORY COMPLIANCE DOCUMENTATION AND RECORDKEEPING
PROCESS VALIDATION TRAINING COURSE (FDA AND EU ANNEX 15: QUALIFICATIONS AND
VALIDATION)

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