FDA Rules for Investigating Out-of-Specification (OOS) Test Results

Date: April  22, 2025
Duration: 60 Minutes
Time: 12 PM EST

One of the most common observations cited in the FDA 483s and warning letters is inadequate investigation of out-of-specification results in GCLP or GMP laboratories. The OOS could be in a test results for a clinical assay or for an analytical release assay. Either way, the OOS must be investigated in a way compliant with the applicable FDA regulations. OOS investigations are also linked to the repeat assays and residual testing. A lot of confusion surrounds the FDA expectation regarding handling and investigation of an out-of-specification result and to deal with FDA audit findings.

This webinar will help you understand how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The focus will be on the FDA guidance and suggestions for a process that will meet the FDA expectations.
 

Areas Covered in the Session:

  1. The requirements for laboratory OOS investigations
  2. FDA Regulatory expectations
  3. Trends in FDA findings for improper OOS investigation
  4. The laboratory OOS investigation process
  5. Retesting
  6. Resampling
  7. Communicating with Quality Assurance

Who will benefit:

  1. Quality Control labs
  2. GLP, GCLP and GMP Lab technicians
  3. Senior management
  4. Production management
  5. Quality management
  6. Quality assurance managers and supervisors
  7. Regulatory professionals
  8. Quality control managers, supervisors and analysts

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

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Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com