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.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
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.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
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.
