Investigation of Out-of-Specification Test Results

Paul Larocque

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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
  1. Initiation of a production investigation.
  2. Invalidation of the initial result and accept the retest result.

Areas Covered in the Webinar:

  • What does FDA say?
  • Resampling
  • Averaging
  • Outlier Tests
  • Out-of-Trend
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Paul Larocque, President, Acerna Inc

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.

Get in touch

(315) 632-0735,
(315) 750-4379