Out-of-Specification 2021 - Investigating Out-of-Specification (OOS)

This webinar will review the regulatory requirements for investigating 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
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Definition Atypical or Out of Specification Result?
Review of the FDA Guidance for Industry on Investigating OOS Test Results
Phase I: Initial Laboratory Investigation
Phase II: Full Scale Investigation
Speaker:
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.