Training Doyens

To reduce and prevent human errors it is essential to understand human behavior, the psychology of error and root causes for human error deviations . Our upcoming webinar discusses practical approaches and models for addressing and controlling human error in GMP related environments. The webinar covers the following key areas: ·          Root cause determination and investigations ·          Establishing the human error rate at your site ·          Implementing the human error reduction program Human Error Reduction Training LEARNING OBJECTIVES Understand the psychology of error Regulatory requirements in GMP environments for managing human performance deviations Root cause determination and investigations Root cause determination tool Establishing the human error rate at your site Implementing the human error reduction program Metrics ...

OVERVIEW If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the  “Responsibilities of quality control unit” and it states that “ (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated…” That being said Human Error is NOT a root cause. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be controlled for human error reduction. T...