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Investigation of Out-of-Specification Test Results

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

$999.00
Introducing
Purchase using Webinar All-Access Pass
One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Jan-2022

Download File Only

(PPT + Recorded Training File)

$399.00
Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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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.

Instructor Profile:
Paul Larocque 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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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