Human Error 2nd Edition

  • Kohinoor Continental, Andheri – Kurla Rd, J B Nagar, Andheri East, Mumbai, Maharashtra – 400059

This training will discuss regulatory requirements for detecting, correcting and preventing Human Errors in manufacturing and laboratory environments alongwith developing a competent, effective corrective and preventive action system.

Analysis of investigation reports reveal that Human Errors is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA’s that are developed from these, rewriting and retaining of SOPs emerges as main problem. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA’s are ineffective. Does it mean that the CAPA’s 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 Errors” is not really 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 training 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 CAPA’s that have a chance to remedy these problems, the first time. We will focus on how to assess the success of these CAPA’s. 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.

Course Director

Guest Speaker

Learning Benefits :

  • Identify why Human Errors is often designated the root cause of deviations and discrepancies.
  • Identify why your CAPA’s are less effective than you hoped.
  • Understand why Human Errors is not the real cause of the deficiencies and deviations.
  • How to probe further to identify the causes or contributing factors that really 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 Errors during data entry.
  • Most common GMP issues caused by Human Errors during laboratory and manufacturing processes.

Quality Assurance Personnel

Quality Control Personnel

Project Managers working in the CMC arena

Supply Chain and Logistics Managers

Regulatory Affairs Professionals

Process Development Scientists and Management

Manufacturing Management and Scientists

Module I :

  • Overview of Human behaviour Impact in the Pharmaceutical arena
  • Fault of people, systems, facilities or Quality Culture?
  • How Human behavioural Choice can hinder Compliance
  • The human limitations & The human Advantages
  • Digitalization & Remote Working
  • Various interlinked Covid-19 Aftermaths

Module II :

  • Regulatory/GMP Aspects as per Inspectional 483s & Warning Letters
  • The Global Regulations & Directives
  • The sequence – Detection, Correction, Prevention & Control of Human Errors
  • Learning from GMP Inspections observations & concerns
  • Implementation via Robust Pharmaceutical Quality Systems

Module III :

  • Criticalities of SOPs & Quality Oversight
  • Inadequate Written Procedures
  • Failure to Follow Written Procedures
  • No Risk evaluation Management Strategy

Module IV :

  • Customized methodology/ Techniques for Investigating Human Errors
  • Analysis of Human Errors/outcomes with respect to RCA, CAPA & Control Strategy [ies]

Module V :

  • Risk Evaluation with respect to different Categories of Human Errors
  • Relevant Tools for choosing correct and appropriate CAPA
  • Adequate Deviation Management System with respect to characterization of Deviations
  • Thorough Investigations & Scientifically justified Closure to arrive at RCA
  • SOPs & Training for Effective Control Strategies

Module VI :

  • Causes & Categorization of Human Errors – Initiatives & Control strategies
  • Human Factor or System Factor?
  • Disregarding Safety, Messing Around, Fatigue, Speed Working, Poor Training
  • Absence or Lack of Written Procedures or Failure to Follow Written Procedures
  • Failures in Laboratory Controls
  • Faulty Production Record Reviews
  • Improper Cleaning/Sanitizing/Maintenance

Module VII :

  • Effective Strategies for minimizing Human Errors in the Workplace
  • Identification of the Error Reduction Zones in the manufacturing and quality control
  • Designing Scope of Improvement for equipment, documentation and systems [PQS]
  • Redesigning of Procedures: Standard operating procedures and formats
  • Quality Oversight – Measures to Improve Supervision
  • Improved & Timely Communication across CFTS at Multiple Sites
  • Appropriate Work delegation & Adequate Training

Module VIII :

  • Exemplary Case Studies for Human Errors Handling
  • Real Life Examples from Cross functions of Pharmaceutical Activities
  • Human Errors in deviations, discrepancies non-compliance & other quality incidents
  • Practical Challenges with respect to implementation, solutions & the way forward

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