Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories) April 11, 2013

This 90-minute webinar on laboratory OOS investigations will review the regulatory requirements for an OOS Investigation. You will learn common regulatory pitfalls and how to structure an Investigation report that satisfactorily documents the investigation.

Why Should You Attend:

FDA inspectors have in the past identified OOS Investigations as the leading cause for concern in Pharmaceutical laboratories. A review of the Warning Letters issued in the past year shows that OOS Investigations continues to be among the most frequently cited area. The Investigation system will therefore continue to receive close scrutiny during FDA inspections in the coming months and years. The large number of citations indicates that though the regulation in this area have not changed, they are either not well understood or that organizations face practical difficulties in complying with them.

This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be identified by a review of recent Warning Letters. The structure of an Investigation report which satisfactorily documents the investigation will be discussed. Ample time will be available for Q&A halfway through the webinar and at the end.

Areas Covered in the Seminar:

- FDA requirements for handling OOS/OOT results.
- Phase I- Laboratory Phase of Investigations.
- Phase II – Full Scale Investigation.
- Concluding an Investigation.
- Out-of Trend investigations.
- Common pitfalls during OOS Investigations.
- Review of recent OOS related citations in Warning Letters.