Create Great Out-Of-Specification (OOS) Procedures

Event Information
Product Format
Live Webinar
Conference Date
Add to my calendar   Tue, Jun 12, 2018
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
60 minutes
Product Description

What To Do When You Detect an OOS Result

Missing or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in warning letters from the U.S. Food and Drug Administration (FDA). While most companies do have procedures in place, these are not adequate—or are not followed.

Join pharmaceutical consultant Danielle DeLucy in this live webinar as she guides you through the entire process from detection of an out-of-specification result to informal and formal laboratory and batch investigations.

After attending this audio event, you will know the FDA’s requirements for handling OOS results, phase I and II lab and full-scale investigations, Out Of Trend (OOT) investigations, and common pitfalls during OOS investigations.

Session Highlights

Here is a taste of what you will uncover:

  • FDA requirements for handling OOS and 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
  • A review of recent OOS-related citations and warning letters

Who Should Attend

  • QA managers and personnel
  • Analysts and lab managers
  • CAPA management
  • Regulatory affairs
  • Training departments

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous...   More Info
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