Human Errors in GMP Manufacturing and Laboratory Processes Identification, Correction and Prevention, Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error

Ginette Collazo
From: Sep 20, 2022 - To: Dec 31, 2022
Recorded Webinar


This instructor-led live training webinar will discuss regulatory requirements for detecting, correcting, and preventing human errors in manufacturing and laboratory environments as well as developing a competent, effective corrective and preventive action system.

Areas Covered:-

  • Identify why human error is often designated the root cause of deviations and discrepancies.
  • Identify why your CAPAs are less effective than you hoped.
  • Understand why human error is not the real cause of the deficiencies and deviations.
  • How to probe further to identify the causes or contributing factors that cause the problems you are seeing.
  • How to develop a true CAPA for these problems.
  • Develop an efficient and effective CAPA system to remedy the ingrained problems.
  • Identification and prevention of human error during data entry.
  • Most common GMP issues are caused by human error during laboratory and manufacturing processes.

Why Should You Attend:-

Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies, and quality incidents in pharmaceutical manufacturing. And when you examine the CAPAs that are developed from these, retraining and rewriting of SOP are top of the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPAs are ineffective. Does it mean that the CAPAs were wrong or is it pointing to another problem? Namely, that the investigation did not pinpoint the root cause of or most probable contributing factors to the problem. Most often "human error" is not the problem but a symptom of a system or facility or operation that is not designed to be run by humans. Humans do contribute to problems but more often than not because what we are asking them to do is not designed with humans in mind. So a true CAPA should be developed to solve the problems with the system, facility, and operation rather than focus on remediation of people. This requires investigations to focus on getting to the real root cause and contributing factors.

This live training webinar will walk you through the elements of why we are quick to ascribe fault to people rather than our systems, facilities, and operations. We will hone in on how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information, you will be able to develop meaningful CAPAs that have a chance to remedy these problems, for the first time. We will focus on how to assess the success of these CAPAs. This will lead to a significant reduction of repeat observations which will lead to improved efficiency and right-first-time operations. This live interactive presentation will also discuss the regulations associated with the detection, correction, and prevention of human errors in GMP manufacturing and laboratory processes.

Who Should Attend:-

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Management and Scientists
  • Project Managers working in the CMC arena

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