Executive Exposure under Strict Liability Doctrine in FDA Enforcement

This webinar will discuss the FDA requirements for the involvement of the executive level in compliance governance. It will also discuss two major Supreme Court cases relied upon by the FDA to support their position on strict liability. Attendees will gain an understanding of the FDA policy and steps you can take to mitigate its impact.

Why Should You Attend:

The FDA has a long standing policy of holding senior corporate executives who “stand in a responsible relationship” to the acts of the corporation personally accountable for violations, even if the executive did not know about the violations and did not intend for them to happen. This onerous approach is known as “strict liability” or Responsible Corporate Officer doctrine. It is reflected in many ways, such as addressing FDA Warning Letters to the CEO; naming executives in their individual, personal capacity in consent decrees; even criminally prosecuting executives in certain cases when there is no direct evidence they knew of or condoned the conduct at issue. From this training, you will gain an understanding of the FDA policy and steps you can take to mitigate its impact.

Understand activities executives can undertake to protect their exposure and meet FDA expectations.

Learning Objectives:

• Understand FDA expectations for the involvement of the executive level in compliance governance
• Understand the two major Supreme Court cases relied upon by the FDA to support their position on strict liability
• Understand the steps executives should take to mitigate risk

Areas Covered in the Webinar:

• Strict liability doctrine meaning and origins
• Pertinent Supreme Court cases: US v. Dotterweich and US v. Park
• Current Department of Justice Policy as outlined in “The Yeats Memo”
• Examples of FDA application of strict liability in enforcement actions
• Steps executive managers can take to control their risk level

Who Will Benefit:

• Senior executives, particularly C-suite
• Regulatory Affairs professionals
• Legal Counsel
• Compliance Officers
• Others involved in managing corporate GxP compliance in FDA regulated industry