is being presented by Michael A. Swit, Esq., Special Counsel, FDA Practice, with Duane Morris LLP and airs on Tuesday, May 22nd, 2012. For more details, or to register please visit our site at www.fxconferences.com
At any moment, lightning can strike your FDA-regulated company. It may take the form of an unexpected serious adverse event such as a death attributed to your product, forcing you to consider a recall -- or an FDA inspection exposing severe quality issues – or a tampering incident such as J&J faced twice with Tylenol®. Regardless of how the crisis arises, it is vital that your company be prepared in advance to address the crisis immediately and responsibly.
This audio conference looks at key issues and FDA-regulated company might face during a crisis related to products or operations regulated by FDA, and how to respond to them. Drawing on a real-life case study that directly involved the speaker – the generic drug scandal that rocked FDA and industry during the late 1980s – the presentation reviews how to be prepared for a crisis and how to respond when one arises.
One never expects to be struck by lightning, and if you are not prepared in advance, it likely will be too late to react in the best manner to protect not only the public health, but also to responsibly mitigate the impact on your company and all its stakeholders from employees to shareholders.
