Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more
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.
• 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
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs Departments
• Compliance Departments
• Quality Departments
• Manufacturing Departments
• Production Departments
• Engineering Departments
• Operations Departments
• Research and Development Departments
• Documentation Departments
• Laboratory Professionals