30 Regulatory Response Expert Witnesses Found

Banking - Credit Union turn-around CEO, operational expert, fraud detection, regulatory compliance, lending expert, compliance expert

...• Experience in completing regulatory compliance requirements efficiently and ahead of schedule. • Effective communicator and negotiator: o Repaired corporate reputation with members, staff, regulators, vendors, and credit union community. o Lease negotiations, vendor contracts, complicated litigious strategy and execution. o Excellent presentation skills. Featured speaker at national ALM, state and NCUA conferences. • Successfully managed facility relocation, capital improvement, and fixed asset resource reallocation. Finance and Accounting • Chief Financial Officer responsible for accounting and finance, budgeting, ALM, investments, collections, resource allocation, and capital improvements. • Experience restructuring failing investment portfolios to minimize interest rate risk and maximize earnings. • Budget and Net Worth Restoration Plan development, implementation, oversight and variance reporting to Boards of Directors and regulatory agencies....

Securities & Investments, Banking - RIA, Broker Dealers, Banking, Lending, Estates, Trusts, Fiduciary, Securities, Crypto & Specialty Assets, Reg BI, Accredited, International, Firm Practice, Regulatory, Risk Management, 1031/DST, Complex Insurance Plans, FINRA, OCC, SEC, Forensic, Fraud, Human Resources, Case Strategy, Supervision.

...As a Regional Manager, my responsibilities included overseeing risk management, human resources, public relations, and corporate leadership. I oversaw the performance of over 500 team members. My functional areas of oversight included consumer and business loan portfolios, insurance and investment partners, and various other business lines of production. In my capacity as a Wealth Manager, I managed a credit, investment, and fiduciary portfolio valued at over $5 billion in assets. The revenues generated by these relationships amounted to over $3 million dollars annually. I have successfully collaborated with regulatory agencies, law enforcement, and multinational entities on cross-border matters. As an entrepreneur, I have established several consulting firms serving both consumers and businesses. Furthermore, I take pride in my accomplished public speaking skills, honed over eight years of competitive speech and debate. Hold Series 7 and 66....

Real Estate, Economics - RE finance/investment,Causation/liability,Damages,Consulting expert, Valuation/appraisal/analytics,Fiduciary/ ethics, Due process/diligence, Properties/markets, Cycles, Conservation easements,Housing, Financial economics, Development/building,Loans, Securitization/CMBS/RMBS, Proptech, Leases, Strate

...Roulac and his team have assisted attorneys to successfully pursue their cases on behalf of plaintiffs, defendants and the public interest in civil, bankruptcy, and criminal matters in Municipal/Superior/Federal courts and in public hearings and specialized proceedings before government (city, county, state, federal) and legislative and regulatory (IRS/SEC/FDIC/DOL) agencies. Some key areas of his litigation work include complex damages/causation/ attribution/liability; real estate company/property/ portfolio valuations, and damages; real estate financing; construction defects; development economics; antitrust, lender liability, fiduciary responsibility; environmental damages, appraisal fraud, and real estate securitization. As an expert who works with attorneys in consulting and testifying roles, his perspectives and qualifications are meaningfully different from those who concentrate primarily on litigation....

Aviation & Aerospace, Human Factors - Decision Making, Airline Operations, General Aviation, Training, FAR’s, Incident Investigation, Operations, Compliance, Pilot Error, Crew Performance, Pilot Fatigue, Crew Resource Management (CRM), Situational Awareness, Turbulence Injuries, Passenger Disruptions, Navigation and Communications

Highly experienced recently retired airline pilot and aviation safety representative with more than 50 years of flight experience and approximately 30,000 domestic and international flight hours in both major airline and general aviation aircraft Former air traffic controller, international air safety representative involved in aviation rulemaking, flight instructor, general aviation aircraft owner and operator FAA licensed pilot since 1972 Experienced major-airline captain for 28 years, 19 years as captain in widebody aircraft Areas of expertise include Federal Air Regulations (FAR) Part 121 airline and air traffic control operational safety issues, flight operations, standard operating procedures, regulatory and flight operations manual compliance, crew performance and coordination, cockpit-related human factors issues, crew resource management, turbulence injuries, procedural compliance, aircraft limitations, navigation and communications procedures, and best practices Extensive experience...

Environmental - Site Assessment and Remediation, Sources and Extent of Contamination, Environmental Program Management, Responsibility and Cost Allocation, Regulatory Compliance, National Contingency Plan

...His experience includes contaminated soil and groundwater issues; Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) remedial investigations and feasibility studies; cost estimating and allocation; soil and groundwater remediation and redevelopment; and third-party review and strategic consulting. As a testifying expert and litigation consultant, Dr. Tringale has given testimony at trial in state and federal courts. His opinions have related to compliance with the National Contingency Plan, identification of contaminant sources, assessment of magnitude and extent of contamination, evaluation of remediation programs, review and development of remedial cost estimates, and allocation of cost and responsibility. Registrations: Professional Engineer, California and New York Affiliations: American Society of Civil Engineers; National Ground Water Association; Geo-Institute; American College of Forensic Examiners

Critical Care Medicine, Emergency Medicine - Quality Assurance, Staff Development, Trauma Nursing, Critical Care Nursing, Critical Care Transport, Trauma Transport, Nursing Administration, Sepsis, Core Measures

...I have flown rotor and fixed wing air ambulance doing scene response and interfacility transfer. I have extensive experience as a clinical preceptor and a classroom instructor, for paramedics, nursing students and nurses. I have extensive experience in Emergency Preparedness as well as practical experience in administration and emergency preparedness during COVID. I have taught basic and advanced life support. I also have thorough experience with regulatory compliance, survey readiness (JCAHO, AOA, ACHC) as well as encyclopedic knowledge of the governmental requirements for acute care hospitals. I have developed, implemented and evaluated Quality Assurance/Performance Improvement programs for rotor, fixed-wing air ambulance and acute care hospitals. I have also developed, implemented and evaluated house wide, department specific and company mandated education programs to meet regulatory and governmental requirements....

Slip Trip & Fall, Premises Liability - Snow and Ice Management, Snow Removal Operations, Snow Removal Contract, Property Management, Operations Management, Snowplow, ice control, slip and fall, slip and fall injury, contract performance, service performance, service communication, fleet management, fleet safety, management, duty of care.

...In the professional and industry of fleet management, Michael Wagner has worked in leadership capacities that are responsible for fleet analysis, driver and operator training, risk exposure, fleet safety management, employee training, insurance claims processing, insurance partnerships with brokers and carriers, and developing fleet policies and procedures for organizations. Part of the fleet management responsibilities include monitoring driver behavior and assessing fleet risk, analyzing GPS and telematics data to influence decision-making, coaching, following disciplinary processes to improve behavior, and leading shop management and fleet maintenance programs. In addition to these responsibilities, Michael Wagner has extensive experience in reviewing fleet accidents and collisions, investigating and reporting incidents, and utilizing root-cause analyses to determine potential consequences and outcomes....

Long Term Care, Legal Nurse Consulting - Public Health, Dementia, Urgent Care, Hospice, Palliative, Policy & Procedure, Documentation, Intravenous access, Prison RN, Nurse Manager, Spinal Cord, Nurse Educator, Hospital Protocol, Evidence Base Care, Diabetes prevention Educator, Veteran's Health, Infection Control, wound Care

...She is responsible for assuring compliance with Joint Commission and other internal/external regulatory agencies implementing actions to meet established performance measures. Dr. Augustin creates competency-based programs for nursing staff. She develops educational activities such as remediation, certification, mentoring, life support, Joint Commission requirements, product rollouts, etc. Dr. Augustin served as the VA facility's clinical instructor supervisor for several years. She covered all areas, including telephone care lines, care coordination, ambulatory care (outpatient clinics, specialty clinics, dialysis, bariatric, rheumatoid, and spinal cord), emergency care, and long-term care for over seven years. Dr. Augustin undertakes the leadership role of resolving highly complex ethical issues that affect the health organization. She served on many committees, including the ethics committee. As a clinical expert, Dr....

Nursing Administration, Medical Management - Nursing Standard of Care, Nursing & Hospital Administration, Emergency Room, Critical Care Nursing, Root Cause Analysis, Risk Management, Fall and Pressure Ulcer Prevention, Wound Care, Medication Safety, Nursing Home, Home Healthcare, Hospital Policy, and State & Federal Regulatory Compliance

...Responsible for Patient Care Services and Risk / Regulatory Services. Currently, Dr. Frumenti serves hospitals in an interim management and consulting capacity, and as an Expert Witness for medical malpractice, personal injury, civil, workplace safety and product liability cases serving plaintiff and defense attorneys. Areas of Expertise: *Nursing Standards of Care *Hospital Administration Standards *State, Federal, Joint Commission Regulatory Compliance *Root Cause Analysis *Nursing Home & Home Health Care Standards of Care *Wound Management, Prevention & Care *Quality and Risk Management *Fall Prevention/ Management *Nursing Contracts

Neurology, Interventional & Vascular Radiology - Inpatient Rehab, Orthopedics, Stroke, Home Health, Neurointerventional, Neurointerventional Radiology, Neuroradiology, Nursing Administration, Clinical Trial Coordinator, Clinical Regulatory Analyst, Director of Quality, Neurointerventional Clinical Director and Comprehensive Stroke Registered Nurse

...As A former clinical regulatory analyst, I was responsible for maintaining the quality of care of all stroke patients. This included medical and endovascular management. I am currently the clinical director for a large, Neurointerventional Surgery practice in the state of Florida. I routinely review endovascular stroke cases and neuroimaging with our Neurointerventional Surgeons. This includes the diagnosis, treatment, and management of stroke. Specifically, I am adept in neurovascular imaging both in terms of anatomy (CT angiography) and physiology (CT Perfusion) allowing the determination of eligible neurovascular candidates. I am fully aware of the standard of care in this specialty. We also incorporate the current American Heart/American Stroke Association guidelines into our practice. Our physicians serve as expert witnesses and I am involved with this component of our practice also....

Accident Reconstruction, Transportation - Trucking safety, commercial motor vehicle accident, cargo tank truck, forklift injury, trucking accident, truck loading/offloading injuries, bus accident, loading rack, driver qualifications, truck rollovers, truck/car accidents, highway construction zone accidents

Highly qualified and well rounded expert opinion is supported by nearly 30 years experience in the highly specialized field of commercial motor vehicle (CMV) crashes, incident investigation and general CMV transportation, including 17 years at the helm of a nationwide incident and hazmat response company. Personally responded to in excess of 1,000 CMV crashes; 200 cargo-tank incidents; loading rack incidents; loading/offloading incidents with CMV involvement, all when serving in the capacity as incident/crash response. As an Expert, served as a CMV expert in over 20-states....

Banking - Bank Analysis, Banking Law & Regulation, Banking Industry Standards, Board & Management Responsibilities, Bank Policy & Procedures, Regulation & Supervision, BSA/AML, Fraud, Ponzi Scheme, Elder Financial Abuse

...Abernathy works closely with Retaining Counsel and brings his broad base of Regulatory & Banking Expertise to the case. He has a successful track record as Expert Witness utilizing strong Expert Analysis, Witten Reports, and effective oral Depositions. Bill has worked with both Plaintiffs & Defendants in Federal & State Courts with NO Daubert Issues. Bill has a long (50 years) and varied career as a National Bank Examiner, federal bank regulator, senior-level banker (EVP & SVP), and bank consultant. He served in six different District Senior Management positions with the Office of Comptroller of the Currency (OCC). His OCC Roles included serving as Assistant Deputy Comptroller (#2 Executive for the 9 Southeastern states); and within that district he led supervision of the 15 largest National Banks & problem banks; served as Director for Compliance & Bank Analysis; and led supervision of 100 community banks in GA, NC & SC....

Radiation Oncology, Radiology - Medical Physicist, Radiation Safety, Accelerator, Brachytherapy, Dosimetry, Radiation Therapy, X-ray, Radiation Therapist, Radiation Oncologist, Radiologic Technologist, Cancer, Oncology, Radioactive, Dosimetry, Patent, Copyright, Physicist, Dosimetrist, Technologist, Implantable, Patent

American Board of Radiology - Board Certified: Radiation Oncology Medical Physicist Nuclear Regulatory Commission - Radiation Safety Officer - Authorized Medical Physicist State Licensure / Registration - Texas: Licensed Medical Physicist - Kentucky: Authorized Medical Physicist & Radiation Safety Officer - Indiana: Authorized Medical Physicist - Tennessee: Authorized Medical Physicist - West Virginia: Authorized Medical Physicist - Missouri: Authorized Medical Physicist ______________________________________________ Responsible for all scientific and technical aspects of radiation therapy, including imaging, dosimetry, calculations, and radiation safety. Supervise medical physicists, dosimetrists, radiation therapists, radiologic technologists, x-ray technologists.

Nursing Homes, Nursing Home Administration - Nursing Home, Nursing Homes, Dementia, Abuse, Pressure Wounds, Bed Sores, Neglect, Nursing Home Staffing, Wrongful Death, Fall and Fall Prevention, Failure to Prevent Accidents, Safety Hazards, COVID 19, Infection Control, Standards of Care, Nutrition, Dehydration, Sepsis, Affidavits of Merit

.... - Founded True Review in 2020 to provide world class nursing home expert witness services - Successfully operating and managing all aspects of the company, demonstrating astute leadership, driving growth, and ensuring seamless day-to-day operations - Has a network of LNHAs, RNs, regulatory experts, and physician expert witnesses available to professionally represent every facet of your case - Responsible for vetting and training True Review Experts Nursing Home Leadership - 12+ Years in Nursing Home Leadership Roles - Executive Director – at multiple facilities - Operational excellence at multiple senior care and skilled nursing settings - 100+ bed, 300+ employee, $20M+ facilities both for-profit and non-profit COVID-19 Experience - Successfully managed and led a nursing home in Massachusetts through the COVID-19 crisis - Led facility infection control practices resulting in positive impact to COVID containment and mitigation - Additionally, resulting from Jared’s leadership, the...

Physician Assistant, Emergency Medicine - Emergency Medicine and Urgent Care: Dr. Cannell can testify himself for PAs and NPs as well as provide malpractice case merit review, expert witness, deposition, and expert testimony.

...Healthcare Law training regarding regulatory compliance and auditing including the broad application of knowledge in different therapeutic areas. ED utilization review, population management, and healthcare utilization review. Anticoagulation, Antimicrobial, and P&T committee member responsible for researching and maintaining evidence-based, up to-date-data to create safe and effective medical management in a large healthcare system. Participant in various ED and Health System committees. Professional Society Membership: American Academy of Physician Assistants Massachusetts Association of Physician Assistants Society of Emergency Medicine Physician Assistants Association of Physician Assistants in Legal Medicine

Pharmaceutical Research, Chemistry & Chemicals - API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism

...SERVICES OFFERED: • Expertise in Chemical Development o Evaluation and optimization of synthetic routes to drug candidates o Adaptation of discovery chemistry routes for scale-up o Chemical process development and optimization o Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and plans o Design of syntheses of stable isotope and radiolabeled molecules for in vivo studies o Physicochemical characterization o Solid state chemistry – polymorphism, salt screening and selection o Sourcing of raw materials, excipients and standards • Vendor Selection, Engagement and Management o API, drug product, analytical, custom synthesis, QA and regulatory support o Creation of requests for proposal o Definition of scope of work, deliverables and timelines o Facilitation of performance and completion of work o Technology transfer - assembly of tech transfer packages, performance of tech transfer to and between vendors and organizations o Excellent vendor network...

Safety, Agriculture Engineering - Accidents, Auto ADAS, Agriculture, Battery Fires, Cannabis Processing, Chemical Exposure, Child Safety, Construction, Electrocution, Ergonomics, Fitness Equip, Fires/Explosions, HazCom, Human Factors, HVAC, Mechatronics/Nano, Medical Devices, OSHA, Recalls, RV/ATV, Slip/Fall, Vapes, Warnings/Label

...Department of Labor, he was appointed as Special Assistant for Safety to OSHA’s Assistant Secretary of Labor, where he had responsibility, among other things, for revising the OSHA Safety Standards (29 CFR 1910 and 1926). Dr. Miller has authored a chapter titled "Hazard Communication and Right-to-Know: Regulatory Issues" in the Safety Engineering Handbook for ASSE. He has also authored five books on the topics of “warnings and safety instructions” and dozens of journal articles. He is currently a committee member of the ASTM Technical Committee F15 on Consumer Products. Finally, Dr. Miller is a registered professional engineer and consultant with over 35 years of experience including expert witness work....

Safety, OSHA - Multiple industry safety experience, OSHA, safety & health, serious injury and fatal injury prevention, occupational fatalities, falls, machine guarding, ladder, multi-employer worksite, construction, training, silica, industrial hygiene, respiratory protection, safety management systems, auditing

...This includes roles as an Air Force Bioenvironmental Engineering officer (final rank of Captain, with industrial hygiene and environmental responsibilities), regional Occupational Health and Safety (OHS) management for a hazardous waste cleanup company, OHS management for a Prime Contractor to the Department of Energy (Oak Ridge, TN), construction safety and construction fatality research for the University of Tennessee under contract to the Department of Labor/Occupational Safety and Health Administration (OSHA), OHS management for a consumable dental supplies and metals related manufacturing/machining company, OHS management for an international gas engine manufacturer within a global automotive manufacturer, regional environmental, health and safety (EHS) management and global safety team member for a Tier 1 auto parts manufacturer, regulatory compliance-focused EHS management for a national disaster restoration contractor under strict EPA requirements, OHS management for an above-ground...

Gaming & Gambling, Security - Premises Liability, Casino Surveillance, Casino Security, Inadequate Security, Hotel Security, Corporate Investigations, Investigations-Criminal Matters, Investigations-Civil Matters, Compliance Investigations, Due Diligence Investigations, International Investigations, Gaming Regulatory Compliance

...As the senior security executive, he was responsible for developing, implementing and managing corporate security, guest and premises security programs for multiple property operations, including CCTV surveillance and security systems. He has consulted on domestic and international investigations and security matters. Investigations included, but were not limited to, compliance investigations of individuals, corporations and companies, violations of local, state and federal laws, violations of gaming regulatory compliance, and civil matters. He has conducted operational audits of gaming security and casino surveillance operations and assisted clients with installation of CCTV surveillance and security systems.

Insurance, Products Liability - Asbestos, Pollution, Premises Liability, Occurrence Limits, Agent's Liability, Sexual Abuse, Stacking of Limits, Property, Businessowners, Professional Liability, Claims Handling, Compliance.

...At The Home was responsible for all regulatory compliance as well as the relationship with insurance regulators and legislators. Had overall responsibility for all product development, state filings, and market conduct examinations. Worked with line departments, especially Major Accounts, to tailor standard products to meet the needs of large account policyholders. Have provided expert opinions on a broad range of P&C topics and on a health case.

Industrial Hygiene, Safety - Occupational health, emergency planning and response, job hazard assessment, personal protective equipment, fall protection, respiratory protection, chemical safety, air sampling, workplace surveys, disaster recovery, pandemic planning, hazard communication, confined space

...He served as the designated company witness for AT&T in asbestos litigation since 2009 and designated by the company as a witness in investigations by regulatory agencies in a variety of matters related to environment, health and safety compliance. He is experienced serving as an expert witness, developing processes and documents to support compliance with consent judgment orders and other enforcement actions. He has extensive knowledge and experience in hazardous materials response and has provided training for hundreds of emergency response workers under OSHA HAZWOPER. Mr. Collipi has designed, developed and trained volunteer workers in emergency programs for Western Electric in 1980 and then later for AT&T. He served as Safety Director for the AT&T Network Disaster Recovery Team and Special Operations Hazardous Materials Team from 2002 until retiring in 2015....

Safety, Industrial Hygiene - Construction, Research and Development, Environmental, Occupational Health, Noise, Accident Investigations, Risk Management, Fatality Investigations, ISO Management Systems, Insurance, Emergency Management, Drug/Alcohol Use Management, Behavioral Management, Training, Contractor Safety, Owners Rep.

...Technical proficiencies in industrial hygiene, safety and environmental disciplines, regulatory compliance analyses, product EH&S program development, permitting, training, ergonomics, EH&S audit and gap analysis, corrective action development, risk management analysis, workers compensation claims management and wellness programs and construction EH&S within a multitude of manufacturing, construction, research and development, governmental and administrative environments. Owner/President – 2021-present- Marianne Santarelli Safety, Industrial Hygiene and Environmental Consulting Services, LLC • A full-service Safety, Occupational Health and Environmental Consulting Service that provides personal one on one comprehensive consulting on the complete range of EH&S issues, topics, and problems....

Nurse, Legal Nurse Consulting - Nursing Standard of Care, Nursing Administration, Ambulatory Surgery, Surgical and Perioperative Nursing, Traumatic Brain Injury, Hospital Risk Management, Fall and Pressure Ulcer Prevention, Wound Care, Medication Safety, Nursing Home, Home Healthcare, Hospital Policy, Regulatory Compliance

...For nine years, she was responsible for Patient Care Leadership and Risk and Quality Management for this 750 bed academic hospital. Currently, Dr. Persky serves hospitals in an interim management and consulting capacity and as a Certified Legal Nurse Consultant and Expert Witness for medical malpractice and personal injury cases serving plaintiff and defense attorneys. Areas of Expertise: Nursing Standards of Care  Hospital Nursing Care  Nursing Home Care  Home Health Care  Wound Care  Extravasation of Intravenous Line  Brachial Plexus Injury  Traumatic Brain Injury  Assault patient and staff •Surgical and Perioperative Nursing •Quality and Risk Management •Fall and Pressure Ulcer Prevention •Hospital Policy and Procedure •Medication Safety •Nursing Informatics •Hospital Administration •State, Federal, Joint Commission Regulatory Compliance

Aviation & Aerospace, Safety - Air Carrier Access Act, Flight Attendant Emergency Procedures, Training and Program Development, Investigation of Inflight Cabin Emergencies; medical incidents, turbulence, evacuations, fire, etc., Passenger/Cabin Crew Illness/Injury, Threat Error Management, Safety Management Systems, Human Factors

Expert witness, consultant, program developer, trainer and internationally recognized speaker on commercial airline flight attendant and gate personnel training, performance, safety and FAA regulatory compliance. More than 40 years of experience in the commercial aviation industry; holding such positions as: Manager of Health, Safety and Security for Inflight Division, Senior Inflight Safety Investigator, Emergency Procedures Instructor for pilots and flight attendants, Station Manager, flight attendant and customer service supervisor. Other aviation roles included Chairperson of an FAA supported Aviation Safety Action Program for flight attendants, member of the Air Transport Association (A4A)Cabin Operations Committee and co-developer of Passenger Incident Review Committee process for a major global airline....

Telecommunications, Arbitration/Mediation - Toll-Free Numbers, Toll-Free Disputes, Toll-Free Lawsuits, Toll-Free Arbitration, Toll-Free Contracts, Toll-Free Industry, Toll-Free Regulations, SMS/800 Tariff, FCC, SMS/800, Resp Orgs, End Subscribers, Warehousing, Hoarding, Reselling, Toll Free, toll-free, toll free numbers

...In 2013, the NATFA and SMS/800 system responsibilities were assigned to SOMOS, LLC. During the transition, he personally assumed the position of NATFA for approximately two (2) years. At the conclusion of that transition, he started his own consulting company with much of his work involving Toll-Free numbering and services as well as other telecommunications support. Erik currently provides Expert Witness services for Toll-Free Number disputes. As the sole neutral Toll-Free administrator for approximately two (2) years, and in his previous thirteen (13) years of employment with DSMI, he worked with the Federal Communications Commission’s (FCC) Wireline Competition Bureau (WCB), the SMS/800 Management Team (SMT), fellow DSMI managers, industry representatives, Resp Orgs and End Subscribers. He assisted with the establishment, implementation, and enforcement of Toll-Free Regulations and the SMS/800 Tariff to ensure that these resources were used in an open, fair and equitable manner....

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

...Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental applications, revision filings based on new clinical data, new safety information, local labeling, new guideline compliance, and agency comments. Responsible for labeling for headquarter Company Core Data Sheet (CCDS), US (USPI), EU (SmPC), Rest of World, and Japan. Develop, lead label development, gain consensus, and shepherd labeling through management review as Chair of Worldwide Product Circular Review/Approval Committees. Tackle >25 products concurrently across the full product life cycle from Target Product Labeling through Phase II, Phase III, and Post Marketing, and in Adverse Experience Reports....

Civil Engineering, Geotechnical Engineering - Stormwater, Erosion and Sediment Control, Hydrology, Landslides and Slope Stability, Foundations, Settlement, Retaining Walls, Geohazards, Pavement Evaluation and Remediation, Earthwork, Construction and Materials Testing, and Americans with Disabilities Act (ADA) Accessibility.

...His responsibilities have included preparing bid packages, authoring specifications, and construction level drawings, as well as preparing expert reports for the legal and insurance industries. In addition, Michael has experience in the preparation of erosion and sediment control plans, stormwater management plans, National Pollution Discharge Elimination System (NPDES) permitting for construction activities, land development plans, earthwork/grading plans, and existing permit modifications to regulatory and government agencies. These plans consist of the layout, design and analysis of culvert systems, detention ponds, and other best management practices. In addition, he has designed/remediated ADA accessible parking fields, accessible routes, and entries for numerous commercial/real estate projects. Mr. Sheleheda has authored and overseen various quality control and assurance programs....

Transportation, Industrial Design - wheelchair transportation, biomechanics, public transit, railcar boarding, accessible air travel, wheelchair securement, wheelchair restraint, seatbelt, crash safety, ergonomics, accessibility, paratransit, wheelchair lift, medical device, ramp, school bus, walker safety, warnings, usability, ADA

...Her specific competencies include: • Device human factors and ergonomics, covering medical devices, injector systems, drug/device combination devices, device labeling, instructions for use, and intra-uterine devices (usability, safety, comfort, regulatory compliance). • In-depth knowledge of medical device regulations and their application to safety and effectiveness for use (IEC62366). In summary, Dr. Linda van Roosmalen is a highly qualified expert witness with a Ph.D. in rehabilitation science and technology, as well as a B.S. and M.S. in industrial design engineering. Her international publications and multiple patents on wheelchair safety technology and medical device innovation attest to her expertise. Dr. van Roosmalen has not only educated and trained others on wheelchair safety but has also designed electrical mechanical systems to enhance accessibility and transportation safety....

Accounting, Fraud - Forensic Accounting, Accounting Expert Witness, Damages Expert, Certified Fraud Examiner, CFE, Certified in Financial Forensics, CFF, Certified Public Accountant, CPA

PRACTICE AREA • Provides professional services as a forensic accountant, expert witness, arbitrator and consultant to legal counsel for clients involved in complex civil litigation, corporate board and internal investigations, complex insurance claims, bankruptcies, and responses to actions by regulatory and investigative bodies. • Advises on matters related to damages, loss claims, fraud, financial reporting, internal controls and accounting issues, among others. • Subject matters commonly addressed include partnership and investor disputes, breach of contract, fee disputes, tort, professional negligence, misappropriation, bribery, conflicts of interest, whistleblower allegations, probate/trust matters, vendor fraud, M&A post-transaction accounting disputes, antifraud programs, internal controls, loss of value, intellectual property, theft of trade secrets, lost profits, royalties, business interruption, environmental disasters and construction defects....

Transportation, Security - hazardous materials, dangerous goods, chemicals, railroad, truck cargo tank, security, grade crossing, derailment, mechanical , signal, operations, track, locomotive, tank car, packaging, accident reconstruction and investigation, Federal Railroad Administration

...Federal Railroad Administration As a HM inspector for the FRA I was responsible for regulatory compliance inspections of various railroads, shippers, consignees for the proper transportation, loading, and unloading of cars containing hazardous materials. I have inspected literally hundreds of facilities and inspected thousands of railroad tank cars. I have inspected numerous manufacturers of HM packagings and inspected tank car repair and testing facilities. I have conducted numerous grade crossing collision investigations, conducted many train accident investigations, and employee injury investigations which resulted in determining probable cause and subsequent recommendations. I have written hundreds of violations of the regulations resulting in civil penalties without a single rejection of the violation by the FRA Office of Chief Counsel [for being wrong or un-enforceable] or loss in claims collection conferences [similar to an Administrative Law Judge “court”]....