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Investigation of Out-of-Specification Test Results
Event Details
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, 2022
Event Description
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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