Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)

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 Webinar:

• 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

Nanda Subbarao
Senior Consultant, Biologics Consulting Group

Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. As a consultant she has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She serves on the AAPS Stability Focus Group Steering Committee.

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