Compliance Expert Witnesses

This expert has over 10 years of experience in risk management and regulatory compliance in the financial services industry, with a focus on identifying compliance issues and implementing solutions to mitigate risk. In his work with the CFPB, he identified millions of dollars in remediation for consumers. Formerly, he worked in consumer protection roles with the Consumer Financial Protection Bureau and the California Department of Financial Institutions, as well as in compliance and risk management roles at San Diego County Credit Union and Union Bank. Currently, he is a compliance advisor with a national financial services group and is based in California.

This highly-qualified expert has extensive experience in automated external defibrillator (AED) program design and compliance. He earned his BS in public affairs from the University of Oregon and his JD from the Lewis & Clark Northwestern School of Law. He is a member of the Oregon State Bar and an advisory board member of the Sudden Cardiac Arrest Foundation and the National Center for Early Defibrillation. He has been the founder of several firms, including Lazar Jensen Geobel, Fios, Inc., and AED Risk Insights, Inc. Currently, this expert is the founder and president of an AED program compliance company that develops and publishes national AED program design guidelines that describe industry standards for AED programs and the AED Law Center.

This expert has extensive experience with managing day to day operations and safety protocols on large, complex projects for the past 20 years. He has extensive certifications in haz-mat operations and emergency response, specifically as it relates to OSHA compliance. He is a member of the AGC Safety Committee, the National Association of Safety Professionals, and the National Fire Prevention Association. His expert witness experience focuses on construction flaws and OSHA safety violations.

This highly qualified expert has 20+ years of safety administration and leadership experience. He earned his BS in Organizational Leadership from Wright State University and his MS in Occupational Safety and Health from Columbia Southern University. He is OSHA certified as an Occupational Safety & Health Manager and Health Professional and he belongs to the American Society of Safety Engineers. His expertise includes rollout safety policies and procedures, prevent or correct unsafe working conditions, design work areas & policy procedures, address hazard and compliance issues, and develop and benchmark safety standards program. He formerly served as Safety Leader in the gardening department at Home depot.

This expert is a senior-level investment manager with extensive experience in long/short equity investing. He is an expert in hedge fund strategies, securities selection, portfolio management and other investment-related issues. He has provided consulting, investment research and expert witness services to investment funds and law firms since 2004. He earned his masters in business administration from Harvard Business School and is currently a Senior Investment Consultant at a private financial investment consultancy.

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 board certified physician is currently an active consultant in medical billing compliance, device and drug marketing, and claims data analysis. He has recently been involved as consultant and expert witness in Medicare criminal and civil litigation, Qui Tam cases and administrative hearings. The expert recently served as a Medical Consultant for ICD-10 transition, coding, and policy at PricewaterhouseCoopers; he now runs his own consulting business and assists clients with all areas of Medicare coverage and billing.

This expert has experience in Environmental, Health, Safety (EHS) operations specializing in developing and revitalizing EHS cultures to meet regulatory, organizational, and employee needs for significant EHS improvements. He is a certified OSHA Technical Institute (OTI) Trainer for General Industry and Construction, and an Adjunct Instructor, Graduate Studies, Public Safety Management at a University in Philadelphia. His specific trainings include: machine guarding, Chemical Safety assessment, HAZMAT, biosafety, and EHS compliance.

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence. Her experience includes serving as a member of the Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies. She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs. Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including: -IND/NDA/BLA submission management, prosecution and strategy -FDA meetings -Regulatory Liaison activities -Ad/Promo review and advising -CMC

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.

This expert has over 40 years' experience as a registered nurse and administrator in various settings including acute care, home care, and long term care. She is proficient in patient assessment, care planning and collaboration with other healthcare providers. She brings extensive experience in developing, reviewing, and implementing policies and procedures to assure facility compliance with state and federal regulations and standards of care. This expert is currently a self-employed legal nurse and long term care consultant.

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 has considerable experience in organizational compliance oversight for mental health facilities. She earned her B.A. in Criminal Justice and her Master's in Health Administration from Saginaw Valley State University. The expert is a credentialed LBSW and QMHP and QIDP in the state of Michigan, here she worked in the mental health field for 12 years. Most recently, she was a Support Coordinator and Recipient Rights Advisor/Investigator for the Saginaw County Community Mental Health Authority until 2015. The expert now works in Florida as a Regulatory Compliance Leader for a large medical center.

This former Chinese customs official is an expert on international trade and customs affairs, having recently joined a US-based consulting firm as the general manager of their China practice. He earned his BS in business administration and MS in public administration from Shanghai Jiao Tong University, thereafter completing further training in export controls at the University of Georgia. Having worked in Chinese customs for more than a decade, this expert has a deep understanding of Chinese trade controls. He is an accredited trainer for the World Customs Organization and has trained hundreds of foreign professionals on international trade topics.

This certified safety professional (CSP) and authorized OSHA outreach trainer has been in the occupational safety field for more than a decade. A member of the American Society of Safety Engineers, he earned his Bachelor's degree in Risk Management and Insurance and MBA from the University of Georgia.

This expert is licensed as a Civil Engineer and a Land Surveyor in both California and Arizona, and he has worked throughout Southern California. Having earned his degrees in engineering and business from California State University at Northridge, he previously served as the Director of Engineering and Surveying at multiple engineering firms, including the Haaland Group and Crosby Mead Benton. A member of the California Land Surveyors Association and the American Public Works Association, he is currently the Principal of a multi-disciplined firm in California.

This expert in the fields of healthcare information technology, clinical documentation, and electronic discovery holds a Master’s of Jurisprudence in Health Law and Policy from the Loyola School of Law and a certificate in clinical informatics from the Johns Hopkins School of Medicine. She began her career as a medical staff assistant, later becoming the director of clinical information at Saint Therese Medical Center and the director of health information management at Rush-Presbyterian St Luke's Medical Center. She is an active member of The Sedona Conference® Working Groups I and Working Group 11 on Best Practices for Electronic Document Retention and Production and Privacy and Security, the American Medical Informatics Association, the Association of Certified EDiscovery Professionals, the Greater Chicago Area Health Information Management Systems Society, the American Health Information Management Association and the American Society for Healthcare Risk Management.

This qualified expert received his BA and MA from University of Notre Dame and his JD and PhD from Northwestern University. He has authored 15 books and over 80 articles on issues of business law, business ethics, and corporate compliance with a main focus on corporate ethics and compliance. This expert is the former executive director of the Institute for Corporate Responsibility at The George Washington University. He also served as a Lindner-Gambal professor of business ethics and a professor of strategic management and public policy both at The George Washington University. Currently, he serves as an Eveleigh Professor of Business Ethics at a top Indiana business school.

This expert has nearly 30 years of experience in safety management specializing in the maritime and construction industries. After serving with the US Coast Guard for 6 years, he went on to work as a safety engineer for U.S. Marine, Powerwave Technologies, Zee Medical, and PTI. He also served as a forensic investigator for the Maryland Office of the Chief Medical Examiner. He is certified as an OSHA maritime instructor, as well as an authorized OSHA instructor for the general industry and construction sectors. He currently is a managing member of a safety consulting firm that specializes in workplace safety and OSHA compliance. He has specialized experience in safety abatement regarding ladders and stairs, fall protection, and safety inspections and accident investigations identifying workplace compliance issues.

This highly qualified franchising expert has extensive professional experience in franchiser compliance and franchise sales. He received his BA from Texas A&M University and is a certified franchise executive. Formerly, he has served as the vice president of franchise development at the International Center for Entrepreneurial Development and at United Marketing Solutions. Additionally, he has held the role of franchise director at The Dwyer Group, as the vice president of marketing at Allied Systems Industries, and as the director of franchise development at Safeguard Business Systems. Currently, this expert is a senior business analyst at a TX business strategy group and the vice president of international development at a NV fitness company.