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This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.
Principal and Owner, A Regulatory Compliance Consultancy in CO
Master of Science (MS), University of Colorado
Littleton,
Colorado
This highly qualified transportation safety and compliance expert has been involved with trucking logistics for over 30 years. He earned a BS in history and political science from Vanderbilt University and an MS in personnel management from Troy State University. He is certified in homeland security and is a certified director of safety by the North American Transportation Management Institute. Formerly, this expert served as a logistics director and personnel manager for Wal-Mart, a corporate manager of DOT and fleet safety with Georgia Pacific Corporation, and the vice president of safety and compliance with Unisource Worldwide Inc. He went on to become a manager of safety and regulatory compliance at XATA Corporation before opening Haffenden Consulting where he was the owner and proprietor.Most recently, he served as the vice president of safety at CRST International before moving to his current role as a compliance strategy officer at a trucking logistics company in Iowa.
Compliance Strategy Officer, A Trucking Logistics Company in IA
Master of Science (MS), Troy State University
Marion,
Iowa
Find Regulation Expert Witnesses In:
What Can a Regulation Expert Witness Opine On?
Policy Development
Creating guidelines for regulatory compliance.
Compliance Audits
Assessing adherence to regulations and standards.
Risk Assessment
Identifying potential regulatory risks.
Training Programs
Educating staff on regulatory requirements.
Reporting Requirements
Submitting necessary documentation to authorities.
Enforcement Actions
Implementing measures against non-compliance.
FAQs for Regulation Expert Witnesses
What is a regulation expert witness?
A regulation expert witness is a specialist who explains laws and compliance standards in legal cases. They assist by reviewing records, offering opinions, testifying, and clarifying complex regulatory issues.
What types of cases may require the expertise of a regulation expert witness?
A regulation expert witness handles cases involving regulatory compliance, government investigations, licensing disputes, enforcement actions, corporate governance, and industry-specific regulations.
How can a regulation expert witness bolster compliance arguments in litigation?
A regulation expert witness bolsters compliance arguments by interpreting complex rules, validating adherence, and linking documented practices to specific regulatory requirements.
What qualifications should counsel require from a regulation expert witness?
Counsel should require a regulation expert witness to have advanced legal or regulatory credentials, substantial industry experience, prior testimony history, and strong analytical skills.
How does a regulation expert witness evaluate regulatory risk in disputed transactions?
A regulation expert witness evaluates regulatory risk in disputed transactions by reviewing laws, guidance, internal controls, and transaction data to assess compliance gaps and potential violations.
What is Expert Institute’s process for selecting regulation expert witnesses?
Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.