The guide, released by electronic quality management system provider MasterControl, features advice from a senior regulatory operations officer at the Office of Compliance of the FDA's Center for Drug Evaluation and Research (CDER).
In the paper, the FDA inspector, with17 years of experience, provides insights on the issues commonly encountered by companies seeking FDA compliance in good manufacturing practice (GMP).
Companies will be advised on what they should do to prepare for a GMP inspection as well as the main things that investigators look for in terms of training and training control - including the top three areas that FDA investigators are trained to focus on during GMP inspections.
Readers will also learn what investigators look for when evaluating a CAPA system; the most common reasons why pharmaceutical companies receive a Form FDA-483; and what they should do when they receive a Form FDA-483.
The free download is available <a href="http://www.mastercontrol.com/land/email/fierce-biotech-cdrh-inspector.php5?source=x3m-fb"target="_blank">>here.</a>