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
FDA Faculty Paul Larocque

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. 

Choose a Purchase Option


$265

Early bird Live Single Attendee

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Live Group Up to 5 Participants

You get 1-5 log-in for the live 60 minutes webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email.

$266

Recorded Access Single User

You'll have 12 month single user access to log-in for an archived recording of the entire 60 minutes webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

MP3 Download - Training DVD

Multiple User Access

Free shipment within 4 Working Days, from the date of webinar completion. Get life time access for unlimited – participants