Human Error occurs in all settings. In the world of pharmaceutical and medical device manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients.
Human error is a frequent occurrence 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 describe the nature of human error in terms of how it is manifest and it distinct properties. As human error is directly related to human performance, we must discuss the contribution human performance has upon the inherent error that is performed by workers in life science settings. The impact of human error in manufacturing will be examined as a prelude to the discussion of human error investigation and root cause determination.
Areas Covered in the Session:
- 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
Why should you attend?
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.
Who will benefit?
- Packaging engineers
- Operations personnel
- Regulatory associates
- Medical device research and development associates, scientists, managers and directors
- Quality assurance and quality control personnel in the medical device industry
- Compliance managers and directors
This webinar will benefit everyone in the life sciences who works within the pharmaceutical and medical device setting, 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.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex regulatory, training and documentation issues.