Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)

Instructor: Nanda Subbarao
Product ID: 701487
Training Level: Intermediate
  • Duration: 90 Min
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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 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

Instructor Profile:

Dr. Subbarao, received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee. She also serves on the AAPS National Biotechnology Conference Programming Committee for 2009 to 2011 as the Regulatory Sciences lead.

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