Training & Events

Investigations, Root Cause Analysis and CAPA

Even the most robust systems and processes have the need to investigate unexpected issues or failures. The way investigations are handled is a critical example of compliance and is often a key component to assuring the safety of health products.

In this interactive, hands on class we will discuss the regulatory expectations around incident management, sources of incidents, how to investigate low risk issues and when to escalate to a large scale quality investigation. One of the most important aspects of a thorough investigation is the ability to identify the root cause of the issue. Tools and techniques for approaching an investigation to identify the root cause will be discussed and practiced. The final phase of an investigation is to identify corrective and preventative actions to address the specific deficiency and prevent it from reoccurrence.

This investigative process is a regulatory requirement and by the end of this two-day course, participants will have the tools they need to effectively approach investigations.

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