Short Abstract

FDA in the recent past has become much more enforcement minded. The number of Warning Letters issued so far in 2014 are on pace to increase by almost 50% over the number 2013 Warning Letter. Your firm needs to be prepared and implement controls based upon what FDA currently expects. Past compliance may no longer work. FDA has raised the bar. We will discuss those areas of your firms operations that are most likely to show problems that will show up on FDA-483’s and Warning letters, and how to avoid being the subject of FDA regulatory actions. We will talk about how to implement actions to avoid FDA problems. We will also discuss how to talk to FDA to avoid FDA regulatory actions. Your instructor has been both an FDA employee and an employee in private industry. In addition he has been a high level FDA manager, and a senior executive in private industry, thus he has truly lived in two different worlds, and can speak from personal experience. Key goals of the Webinar will include: Understand what is going on in FDA that has them more enforcement oriented. Become familiar the types of medical device issues on which FDA concentrates Identify preventive actions that can be taken to avoid FDA issues Know how to respond to an FDA-483 to avoid a Warning Letters Know what to expect if a follow-up inspection results in an FDA-483 Know how to meet with FDA and what to not say or do Know how to negotiate with an FDA manager to resolve issues. Know how to train your own employees in methods of dealing with FDA