Human Error Prevention in Pharmaceutical Manufacturing

Product Id : FDA157
Instructor : Charles H. Paul
Nov 15, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

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.

This webinar 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.

Areas Covered in the Session :

  • Understanding Human Error
  • Nature of human error in pharmaceutical manufacturing
  • Approaches to investigating Human Error
  • The root causes that are directly attributable to Human Error
  • 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
  • Research and Development Departments
Speaker Profile:

Charles Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.


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