The FDA Compliance Enforcement Process

Why Should You Attend:

Attendees will gain insight into the advisory, administrative and judicial enforcement options the FDA uses, and the situations when each is typically used. Professionals working in Regulatory Affairs, Legal, Compliance and Quality Assurance will be better able to gage the risk their companies may face when an FDA inspection goes poorly or other problems arise with FDA compliance matters.

Areas Covered in the Webinar:

Explanation of FDA Enforcement Options, with focus on the pharmaceutical and medical device industries, including:

• Advisory actions
• FDA 483 observations
• Untitled Letters
• Warning Letters
• Administrative actions
• Biologics license suspensions and revocations
• Enforcement options for clinical trial issues
• Application Integrity Policy (fraud policy)
• Administrative detention
• Import Alerts and Refusals of Admission
• Judicial actions (civil and criminal)
• Product seizures
• Injunctions
• How seizures and injunctions can be negotiated by consent decree
• Criminal Prosecution

Who will Benefit:

• Regulatory Affairs professionals
• Legal Counsel
• Compliance Officers and other compliance professionals
• Quality Assurance
• Auditors
• Corporate executive staff responsible for risk management

Instructor Profile:

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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