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Investigation of Out-of-Specification Test Results

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On-Site / Webinar
Ended last Jan 18, 2022
USD  249.00

Details

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.

Schedules

No. of Days: 1
Total Hours: 2
No. of Participants: 10
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At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

ComplianceOnline
2479 East Bayshore Road Suite 200 , Palo Alto, Los Angeles , California, USA 94303
888-717-2436
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