Understanding and Mitigating Human Error in the Life Sciences
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, 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 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.
This webinar will explore the true causes and nature of the 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.
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 occurrence in pharmaceutical manufacturing. It occurs even when every obvious preventive action has 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 involves retraining or disciplinary action. These approaches do not seek to understand really why the error(s) occurred.
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 the 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
- Human error and human performance
- Human error in manufacturing
- 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
Course Level - Intermediate/Basic
Who Should Attend
This webinar will benefit everyone in the life sciences particularly those that work within the pharmaceutical and medical device settings, engineering, quality, and regulatory functions or services to include, machine operators and mechanics, quality assurance, technical services, laboratory, regulatory, engineers, documentation development and management with titles such as associates, technicians, scientists, supervisors, managers, and directors.