Thursday September 6, 2018
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Within the past several years the regulatory agencies have advised their regulated Client firms that the enforcement environment is having the bar raised, i.e., that the regulatory agencies are no longer willing to tolerate the on-going violations that may have previously been tolerated within their Companies. As a consequence, more regulatory actions as well as the threat of seizures and consent decrees are now becoming the norm within these regulated industries. As an example, times were when it required three FDA Form 483s to create a Warning Letter. In today’s environment, this will occur after two. Import Alerts are also more frequent and usually have a Warning Letter follow within one to four months.