It can — and does — happen! Earlier this year, the CEO and general manager of a medical device manufacturer were personally named in a costly consent decree after a seizure of their company's inventory following alleged GMP violations.
The FDA upholds the doctrine of "strict liability," stating that corporate officers can be personally liable for violations of the Food, Drug and Cosmetic Act. Recently, senior-level executives at a major pharmaceutical company paid millions out of their own pockets as part of product misbranding charges.
How can you make certain the work you and your staff do is in compliance to help avoid violations?
How should you respond when a violation takes place for which you are held accountable?
Here's how ...
In this 90-minute audio CD/transcript, David Chesney will explain how FDA investigators develop evidence regarding lines of responsibility and authority during an inspection. He'll examine the court cases that formed the foundation for the FDA's view on responsibility, and how they affect inspections today.
Order now for your entire team to listen and discover:
David Chesney is vice president, Strategic Compliance Services for Parexel Consulting. Prior to joining the firm in 1995, he spent 23 years with the FDA, ultimately serving as an FDA evidence development instructor at the national level. Since joining Parexel Consulting, he has provided GMP and FDA inspection readiness consulting, auditing and training services to clients worldwide.
Order now and get a full understanding of how to deal with violations and personal responsibility during an FDA inspection.