FDA Regulations Expert Witnesses in Oklahoma

This expert is a certified life care planner and nurse consultant with clinical background in nursing, orthopedics, rehabilitation and critical care medicine. She has extensive background in evaluation of complex and long term needs of clients who have suffered catastrophic injuries. She holds expertise in health care quality and risk management, health care administration, and regulatory compliance. She has been a certified life care planner since 2010.

This highly qualified expert has more than 40 years of international experience in the development and implementation of occupational health, safety, and environmental (HSE) management systems within the petroleum, petrochemical,manufacturing, and construction industries. He is an advisor to management on regulatory compliance with worldwide agencies such as BSEE, EC, OSHA, HSE, PSA, SSM, DEA, USCG, MSHA, MMS, NOPSA and other applicable industry standards and codes. He is experienced with ISO, ISM, Injury Incident Free (IIF) culture building, root cause analysis, and behavior based safety; including 24 years experience with stringent safety requirements of the North Sea regulatory agencies.

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 expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association. He formerly served as a pharmacy intern and the flu clinic supervisor for the student health pharmacy at the University of Wyoming. Currently, this expert is a medical content writer for a medical consulting firm.