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Analytical Laboratory Compliance—An FDA Warning Letter Perspective

Enforcement statistics for the FDA show that in 2013, the agency issued 6,760 warning letters, a 10-fold increase from 2010, when only 673 were issued. The FDA exchanges data with other regulatory agencies around the world, making FDA warning letters an invaluable, free source of regulatory compliance enforcement data. Still, many laboratories are simply too busy to take the time to analyse, interpret or even read FDA warning letters.

In this webinar, we will present an analysis of some recent FDA warning letters to provide regulated laboratories with important insights that could help to improve their operations and reduce regulatory risk.

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Overview


Title: Analytical Laboratory Compliance—An FDA Warning Letter Perspective

Date: Thursday, June 26, 2014

Time: USA 11:00 am EDT / 8:00 am PDT / 16:00 BST

Duration: 60 minutes including Q&A

Speakers


Paul Smith
Compliance Program Manager
Agilent Technologies


Moderator
Celia Arnaud

Senior Editor
C&EN



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