Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

Investigations, Root Cause Determination and CAPA Effectiveness

If you work in a GMP regulated industry you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The Code of Federal Regulations (21 CFR 211.22) charge the quality control unit with the responsibility  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 reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as implementing a process exclusively dedicated to investigating and fixing these problems.

This 90-minute accredited training course offers practical approaches and models to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters. This training will provide you with many practical tools that can be implemented and used in your workplace. We will discuss human error categories, near root causes and root causes for these events as well as discuss the latest trends in human error issues in the industry.