Have you ever had a deviation occur that forced you to retrain staff, had a similar deviation appear, then correct it with another round of the same training on the same procedure?  Have you ever taken significant steps to correct an issue, just to see it recur? If you answered “yes” to either of these questions, then chances are your root cause analysis efforts need improving.

Root cause identification is an expectation of FDA and other regulatory agencies, and is one of the most frequently cited problems during regulatory inspections.  Many companies do not understand the difference between direct causes and root causes of issues, which lead to weak, inappropriate, or ineffective corrective and preventative actions (CAPAs).  Even more companies understand the differences, but are not using an effective process that enables success.

This session will demonstrate an effective investigation and root cause analysis process, and will provide very simple tools that help you identify the true cause of any issue and identify and implement more robust corrective actions.  A true case study will be used to illustrate the difference between what does and what should happen.