Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
Retesting: testing into compliance.
Resampling: when can it be done; when not.
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.Course Content
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.
Speaker
Paul LarocqueCourse Provider
Paul Larocque,
