Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data: One and a Half day In-Person Seminar

Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. The FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS and OOT (Out Of Specification and Out Of Trend). Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities.

This one and a half day interactive seminar will discuss the Guidance for Industry on OOS/OOT investigation issued in October 2006 by the FDA. As testing becomes critical to determine the cause of OOS results, investigation process will be discussed during the session and it will also cover procedures that will minimize OOS and identify OOT. It will also make attendees familiar with the documentation system as well as Corrective and Preventive Actions (CAPA) activities.

• Understand regulatory expectations for OOS (Out Of Spec) investigation
• Define documentation system for reporting data
• Build ruggedness into the analytical procedures to prevent OOS occurrences
• Build compliance into the investigation process to minimize OOS
• Define and monitor Corrective and Preventive Actions

This session will benefit analyst to group manager who are responsible for acquiring, evaluating or reporting analytical results. It is designed to provide key principles for OOS and OOT investigations.