FDA Regulations Expert Witnesses in Missouri

This expert is highly fluent in environmental compliance strategies that take into account state and federal environmental regulations and guidances, and the principles of sound engineering practices. His regulatory expertise includes the regulation and enforcement of hazardous waste, superfund and toxic substance laws and UIC regulations. This expert worked in the U.S. Environmental Protection Agency for 31 years and was EPA's RCRA national hazardous waste expert and one of a few who was also a RCRA and Superfund Remedial Project Manager (RPM). Because of his extensive knowledge, he testified as a government witness in federal court proceedings and inspected and evaluated the largest, most difficult hazardous waste sites involving complicated toxicology and environmental site conditions. He directed the Regional RCRA inspection team and personally evaluated industrial sites, including refineries, oil and gas production and treatment facilities, metal refiners, power plants, and waste disposal sites across the Region to determine their compliance with environmental laws. A registered PE and board-certified environmental engineer, this expert helped the EPA develop policies and rules regarding regulatory compliance, risk assessment, site remediation, and worker health issues at waste disposal sites, hospitals, refineries, oil and gas production and power plants. Since retiring from EPA, this expert has had numerous expert witness engagements where he has written several expert reports and participated in various court proceedings.

This highly qualified expert has provided valuation and corporate finance consulting services since 1987. He is a Chartered Financial Analyst (CFA) and he is a member of several prestigious associations including the Healthcare Financial Management Association and the American Society of Appraisers. He previously worked as the Senior Managing Director of American Appraisal Associates Inc where he was the Chair of Healthcare Industry Practice. Currently, this expert works as Managing Director in a global consulting firm in Illinois. He specializes in the valuation of a wide variety of businesses and business interests, fairness and solvency opinions, consulting with corporations with respect to corporate finance issues, and estimating economic damages. He has provided opinions of value, fairness, and solvency for many purposes such as acquisitions, divestitures, business and strategic plan reviews, business unit performance measurement, SEC filings, US GAAP and other financial reporting requirements, US federal, state, and non-US tax reporting requirements, regulatory compliance, various dispute resolution and litigation procedures and general advisory purposes. This expert has worked with clients across a wide variety of industries such as business and consumer services, construction, engineering and real estate development, construction materials, banking, financial institutions and insurance, healthcare services and managed care.

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.

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.

This seasoned expert specializes in auto finance and lease regulatory compliance, with over 30 years of experience in the consumer vehicle leasing and financing areas. He regularly consults as an expert witness on auto leasing and finance-related matters, including dealer finance practices, insurance sale practices, and Regulation Z & M issues. In addition, he has consulted for the Federal Reserve Board and National Credit Union Administration on leasing and lending regulatory issues. The expert is the Managing Director of a trade association for major retail automobile lessors, and he also runs a private consulting business. He has been cited in numerous publications and occasionally appears on television as a representative of the industry. The expert earned his B.S. from Yale University and has a J.D. from the University of California, Berkeley School of Law.