Guide for US FDA-Regulated Organisations: How to Avoid and Respond to FDA Warning Letters – for Temperature, Humidity and Other Controlled Environment
30 April 2010This ten-step Veriteq guide is designed to help companies that may have to deal with warning letters from the US Food and Drug Administration (FDA), without having a long-term detrimental effect on its business.
It is vital for pharmaceutical companies to ensure they maintain the highest standards as contaminated products can not only damage reputations, but also often lead to expensive court battles.
The guide outlines three deviations noticed in previous warning letters that revealed the lack of temperature records and offered ways to simplify and automate monitoring, alarming and reporting in FDA-regulated environments.
Available Downloads
-
Guide for US FDA-Regulated Organisations: How to Avoid and Respond to FDA Warning Letters – for Temperature, Humidity and Other Controlled Environment
Download