Personal Liability for GMP Violations:
How the FDA Develops Evidence – From a Former Agency Insider

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:

• The significance of the doctrine of "strict liability" for violations of the Food, Drug and Cosmetic Act
• The techniques the FDA uses to develop evidence and documentation of individual responsibility
• Eight items of information FDA investigators use to connect violative conditions and persons to be held responsible
• What FDA investigators ask and look for during inspections
• 11 documents investigators examine to determine individual responsibility
• How to respond to an FDA affidavit citing responsible individuals
• Eight do's and don'ts in responding to investigators' findings of responsibility
• Four steps management officials can take to minimize personal risk