Topics Include:

• Learning how to cope with corporate life under a microscope in an era of heightened governmental scrutiny
  - acts and omissions that may lead to FDA, DOJ, or SEC investigations
  - reducing brazen forms of behavior
• Representing yourself accurately and producing documents to avoid false claims or obstruction allegations
• Fostering proper and ethical behavior through demonstrated compliance with voluntary industry codes such as AdvaMed
  - utilizing codes as a benchmark for ethics
• Understanding when to “toe the line” and when to err on the side of caution in your sales and marketing practices
• Defining who within a company can be “responsible” under FDA standards
  - collateral consequences of a Park conviction
• Working through available defenses to a Park charge
• Analyzing gate-keeper enforcement against in-house and outside counsel
• Determining the value and limitations of seeking outside legal guidance to advise on marketing and other operational matters, as well as investigative issues