Missing or inadequate procedures for out-of-specification (OOS) results and failure investigations are among the most common deviations cited in FDA warning letters. This OOS and OOT investigations webinar reviews the regulatory requirements and how to meet them.
You'll follow the process from detecting an OOS result through the Phase I laboratory investigation and a Phase II full-scale investigation to concluding it, using a detailed flow chart that shows each step and its order.
The session explains the responsibilities of the analyst, supervisor and QA, how to structure an investigation report, how to handle out-of-trend (OOT) results and common pitfalls, with a review of OOS-related warning letter citations.
Most companies have OOS procedures, but they are often inadequate or not followed. This session guides you through the full process, from detecting an OOS result to informal and formal laboratory and batch investigations, so your procedures hold up.
It suits QA/QC and regulatory affairs directors, managers and specialists, and quality control laboratory staff.
Most companies have OOS procedures, but they are often inadequate or not followed. This session guides you through the full process, from detecting an OOS result to informal and formal laboratory and batch investigations, so your procedures hold up.
It suits QA/QC and regulatory affairs directors, managers and specialists, and quality control laboratory staff.
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 filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
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