FDA Rules for Investigating Out-of-Specification (OOS) Test Results
Date: April 22, 2025
Duration: 60 Minutes
Time: 12 PM EST
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:
- The requirements for laboratory OOS investigations
- FDA Regulatory expectations
- Trends in FDA findings for improper OOS investigation
- The laboratory OOS investigation process
- Retesting
- Resampling
- Communicating with Quality Assurance
Who will benefit:
- Quality Control labs
- GLP, GCLP and GMP Lab technicians
- Senior management
- Production management
- Quality management
- Quality assurance managers and supervisors
- Regulatory professionals
- 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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