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Investigation of Out-of-Specification Test Results

Event Details

Investigation of Out-of-Specification Test Results

Time: January 18, 2022 from 10am to 1pm
Location: online
Street: Compliance Online
City/Town: Online
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: webinar
Organized By: ComplianceOnline
Latest Activity: Jan 4

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Event Description

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

Why Should You Attend:

Attendees will learn how to streamline and conduct timely OOS and OOT investigations that meet FDA GMP expectations.

  • Responsibility of the Analyst
  • Responsibility of the Supervisor
  • Obvious error
  • Retesting
  • Resampling
  • Result validation
    • Initiation of a production investigation.
    • Invalidation of the initial result and accept the retest result.

Areas Covered in the Webinar:

  • What does FDA say?
  • Retesting: testing into compliance.
  • Resampling: when can it be done; when not.
  • Averaging: do’s and don’ts
  • Outlier Tests: when they can be used; when they cannot
  • Out-of-Trend: what is out of trend? Statistics.

Who Will Benefit:

Drug and biologic personnel working in production, R&D, regulatory affairs, QA, and QC.


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