Regulatory Affairs Expert Witnesses in Tennessee

This expert has 35+ years of experience providing safety and loss control for the Trucking Industry. He is certified by the National Association of Safety Professionals and the North American Transportation Management Institution. He has completed several courses regarding safety, loss control and compliance issues. Previously, this expert served as the Director of Loss Control and Safety for the Alabama Trucking Association where he was responsible for all loss control activities ($46 million fund) and the development of accident prevention programs. He now is the President and Founder of a Risk Management firm providing expertise in safety and loss control for clients in the state of Alabama.

This expert has more than 25 years of experience as a trusted human resources advisor providing support and subject matter expertise to organizations and their teams. She provides advice and support to leadership in the implementation and delivery of HR programs and the optimization of organizational effectiveness. She is recognized by the DC area Human Resource Association to have a thorough knowledge of legal compliance and enforcement trends of various government agencies and corporations.

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 extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the average consumer will understand, integration of behavior modification and design, working with medical teams to provide documentation required for FDA approval process, and developing health professional’s tools for patient counseling to ensure that the patient education materials are used correctly. She also has expertise in working with medical device companies and packaging companies to ensure that it will be easy for patients to understand the “how to use” instructions and use the products correctly. She received her BSP degree and completed her residency training in hospital pharmacy at the University of Saskatchewan before receiving her Pharm.D. degree from the University of Cincinnati. She is a founding member of the American College of Clinical Pharmacy, a former member of the Board of Directors and Chairperson of the Business Council at the National Council on Patient Information and Education, and is active in many professional and consumer organizations, including the American Association of Colleges of Pharmacy and the Alliance for Safe Online Pharmacies. She has published 150+ peer-reviewed journal articles on patient education and adherence and serves as a reviewer for the American Pharmacists Association. She is the author of 23 books on how to use medications safety for health professionals and consumers. She has appeared on many radio and television shows to help consumers learn how to take their medications correctly. She is also the former director of clinical affairs at the American Pharmacists Association, which honored her with its Foundation Pinnacle Award for her outstanding leadership. Additionally, she is the former coordinator of the ambulatory patient pharmacy at Sunnybrook Medical Center and a former associate professor of clinical pharmacy at the University of Toronto. Currently, she is the CEO of a major patient education company that develops information to help patients understand how to manage their medications, medical devices and therapies correctly, consults with pharmaceutical companies on how to promote patient understanding and patient safety, develops multi-component patient education programs requiring FDA approval, and develops patient education programs for world-wide clinical trials to increase patient adherence so that the approved FDA dosage is more accurate and thus safer.

This expert has over 50 years of experience in commercial motor carrier and trucking industry. His work in the industry has focused on customary practices, standard of care, tractor-trailers, and compliance and safety training and practices for drivers, motor carriers, warehouses and forklifts. He received his certificate in traffic & transportation law & management from the University of Virginia and is active in his field as a member of the Association of Transportation Law Professionals and the Cardinal Criminal Justice Academy. He is certified by the Department of Transportation as a breath alcohol technician and factory authorized calibration technician, by OSHA as a train the trainer in forklift safety, and by FEMA through their emergency management institute. He previously served as the vice president of Russell Transfer, Inc., the senior vice president of Valley Transport Associates, and corporate secretary of Fleetmaster Express, Inc. This expert is currently the managing member of a transportation safety and compliance consultancy in Virginia.

This highly-qualified expert has over 25 years of experience in work zone safety, with demonstrated experience in health and safety management, regulatory compliance, safety auditing and reviews, and accident and incident investigations in areas of construction and mine safety. He earned his AS in electronics systems technology at Community College of the Air Force and his BS in occupational safety and health at Columbia Southern University. This expert holds several certifications in his field, including as a certified safety professional (CSP), a certified construction manager of environment safety and health (C-MESH), an OSHA and MSHA Part 48 metal/non-metal instructor, and a miner. He is also certified in fall protection and electrical safety, holding a NFPA 70E certification. He is active in his field as a member of the American Traffic Safety Services Association. He began his career as an antenna systems technician for the United States Air Force before transitioning to work as a loan officer for Freedom Mortgage Services and a senior financial officer for Carteret Mortgage Corporation. He also served as a lead instructor for the American Red Cross, a traffic control supervisor for Moore & Son, and a health and safety manager for Rogers Group Inc. Currently, this expert is the health and safety director of a safety industrial firm in North Carolina.

This qualified expert has more than 20 years of experience in safety compliance with more than 10 years in managing supermarket and retail location safety. He previously worked at Winn-Dixie Stores as a District Manager and Division Safety Director. He holds several certifications from various associations including the National Association of Safety Professionals and the National Safety Council in Principles of Occupational Safety & Health. He was also formerly acted as Corporate Safety Director for Piedmont Service Group. He currently works as President of a retail safety, compliance, and indoor air quality consulting firm.

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.