Watch Best Practices for Conducting OOS Investigations(-in Pharmaceutical Labora...

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. 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. Who will Benefit: This course is intended to provide training on how to perform OOS/OOT investigations. The following personnel from pharmaceutical, medical devices and biologics companies will benefit from this training: - QC Supervisors and Management - QA personnel - QA Management - Documentation management specialists - Regulatory affairs personnel NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 11th December 2011. more