Overview
Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
Matters to be addressed:
- 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.
Attendees will learn how to streamline and conduct timely OOS and OOT investigations that meet FDA GMP expectations.
Webinar Takeaway
- 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
- QC
Faculty Paul Larocque
President at Acerna Inc.
Greater Toronto Area, Canada
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.
Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.