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.
Areas Covered in the Webinar:
Who Will Benefit:
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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