Major New Risk Management Burden Coming Under Part 11

Washington Drug Letter
KEYWORDS FDA / Part 11
A A

The FDA’s long-awaited revision of Part 11, which is now slated for release in the first part of 2007, will impose major new burdens on the pharma industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.

To View This Article:

Login

Buy This Article Now

Add this article to your cart for $10.00