Unexpected events happen…they are a fact of life during the drug development process. A strong Event Investigation (EI) Standard Operating Procedure (SOP), can be one of the most important documents a company generates. The EI procedure is the first step taken when something out of the ordinary – an event or happening – occurs. It is the hub that points to the other procedures (CAPA, risk assessment, etc.) to capture other elements of the investigation. It is used to capture investigations into events including but not limited to complaints, unplanned deviations, unexpected occurrences and confirmed out-of-specification (OOS) results.
A poorly documented EI can be a sign to an auditor of larger issues, and a health authority fishing-expedition may commence. Conversely, a well-documented EI can keep a therapy moving through development, helping a host of critical decisions. It can tell the proper story to auditors, so they see the work done to resolve and deal with issues. More to the point, it is good science and compliance.
During this presentation we will discuss why executing a proper EI still seems to elude us. It will also discuss how to structure your compliance system to:
- Standardize of the process for performing an EI, thereby eliminating inconsistencies in execution and documentation.
- Capture the process in one procedure instead of several procedures resulting in a more streamline management process.
- Ease the training burden and promote greater compliance with dedicated focus and specificity on a process used by many employees.
We will also detail the process for navigating an EI, specifically:
- Describing the event
- Collecting the data
- Performing a root cause analysis (RCA)
- Performing impact and risk assessments
- Determining Corrective and Preventive Actions (CAPAs) and document changes
- Conclusions and Effectiveness Checks (ECs)