Executive Exposure under Strict Liability Doctrine in FDA Enforcement

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

David L Chesney
Principal and General Manager, DL Chesney Consulting LLC

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC. His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

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