Analytical Laboratory Compliance - An FDA Warning Letter Perspective
CEN Webinars: Stronger Bonds
Analytical Laboratory Compliance -
An FDA Warning Letter Perspective
Thursday June 26th 2014
8:00am PDT, 11:00am EDT and 16:00 BST
SPEAKER
Speaker
Paul Smith,
Compliance Program Manager,
Agilent Technologies
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MODERATOR
Moderator
Celia Arnaud,
Senior Editor,
C&EN
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OVERVIEW

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.

KEY LEARNING OBJECTIVES:

- Best practices for finding valuable warning letters data

- Detailed review and analysis of warning letters for laboratories

- Trends and compliance implications for regulated analytical laboratories

WHO SHOULD ATTEND
  • • Quality, QA/QC, Regulatory Directors/ Managers
  •  
  • • R&D Directors / Managers/ Supervisors
  •  
  • • Regulated Industry Manufacturing and Operations Managers
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