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Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control

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In this training you will learn difference between Out-of-Specification (OOS) and Out-of-trend (OOT), requirements for OOT and how to manage OOT results for FDA compliance.

Speaker
Instructor: Dr. Ludwig Huber
Product ID: 701666
Training Level: Advanced

FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations. The guide states: "Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend". Managing OOT results also helps to avoid time consuming OOS results. This seminar will demonstrate how to manage OOT results for FDA compliance.

Areas Covered in the Seminar:

Hand-outs:

For easy implementation, attendees will receive

Who Will Benifit:

Instructor Profile:
Ludwig Huber Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .

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Training Options Training Duration = 75 Min
$399.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
$700.00 Get Training CD Only
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CD and Ref. material will be shipped within 15 business days