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Date: 26th June, 2008

Location: Web Seminar, USA

Summary:
Clinical, Pharmaceutical - Training

Human error in the healthcare industry has been blamed for many consumer catastrophes resulting in company failure, loss of money and human lives. A breakdown of such errors exposes internal and external factors, including lack of employee information and/or motivation, lack of employee knowledge and/or qualification and over/under estimation of the task assigned. Human performance is often compromised by noise, environment and working conditions. Poorly written procedures, stress, fatigue and lack of adequate supervision can also degrade performance. Adding to this scenario is the wide array of tasks and equipment that pharmaceutical employees are required to handle.

From a regulatory perspective, the Quality Control Unit (QCU) shall ensure that no errors have occurred during the review of production records and if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)). This presentation will discuss regulatory requirements for detecting, correcting and preventing human errors in manufacturing and laboratory environments, and will address the types of human error found emphasizing on impact to product quality. A recommended corrective and preventive action plan will also be included.

Discussion points to be covered include:

• Understanding the impact of human errors in pharmaceutical operations
  
• Identifying CFR sections corresponding to human errors
  
• Identifying types of human errors
  
• Learning when a human error becomes a GMP issue
  
• Learning the difference between a voluntary/intentional human error from a data integrity issue
  
• How to deal with human errors during laboratory and/or manufacturing investigations
  
• Understanding the role of the Manager, Supervisor, Human Resources and Employees
  
• Learning how to correct and prevent voluntary and careless work-type human errors
  
• Evaluation and trending of human errors in GMP activities