Laboratory Compliance 2011 - Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)

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.

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.

NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 11th December 2011.