Thursday, July 28, 2011

FDA Finds Faked Documentation At Cetero

This is a really good example of how improper documentation practices can get a company into real trouble.

Read this Reuter's release, FDA finds drug research firm faked samples, documents.

In a nutshell:

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.
Train your personnel:  
Value-Packed - Overcoming the Documentation Nightmare CBT Class by SkillsPlus International Inc.
Computer-Based Training (CBT) By SkillsPlus International Inc.

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