Product Safety Expert Witnesses: 29

The four PhD and registered PEs at Miller Engineering are celebrating 40 years of Professorships at three universities along with providing services to Government, Insurance, and Industry—through research, publications, presentations, and expert testimony. We have a dedicated office with a full time staff of engineers, researchers, and technical writers. The span of our collective academic and experiential expertise covers well the Mechanical, Electrical, Chemical, Agricultural, Industrial, Human Factors, Ergonomic and Safety fields of engineering. The areas listed below are from actual projects completed in our 40 years of history. 

Vehicles Car/Truck Accident Reconstruction Crash Data Retrieval (CDR) Visibility & Reaction Time Analysis Tires, Trailers, Brakes & Accelerators Truck/Off Road Vehicle Egress/Ingress Traffic Signing and Construction Zones Electronic Vehicles Mechanical & Electrical Safety Product Safety & Analysis Machinery - Metal, Wood, Plastic Molding Machine Guarding & Safety, Robots, Automation Hazard and Risk Analysis Employee Safety Procedures – OSHA Electrical Distribution & Transmission Hazards

Warnings & Instructions Warning Labels & User Manual Design Hazard Analysis & Product Label Designs Medical Device & Drug Warnings & Instructions Inadequate Warnings Analysis Standard Compliance (ANSI Z535) Product Recall Information & Strategies Consumers/Household Safety Appliances & Tools Child Furniture, Choking, Playgrounds Swimming Pools & Exercise Equipment Recreation - ATV, Boats, Bicycles, Boards Ladder, Stair, Step and Railing Accidents Slip, Trip, & Fall Accidents CPSC Recall Information & Strategies

Chemicals Safety & Labeling NEW OSHA HAZCOM (2012) & GHS Review MSDS, SDS and Product Label Compliance Toxic Torts - Diacetyl, Asbestos, Benzene, Lead, Carbon Monoxide Vaping & E-Cigarette Health Effects Chemical Exposures & Workplace Safety Chemical Inhalation, Ingestion, Dermal Contact Contamination - Water & Environmental Manufacturing & Process Line Accidents Slips, Trips, Falls, & Entanglements Fires & Explosions Cause & Origin Investigations Gas, Vapor, & Electrical Spontaneous Combustion Vaping & E-cigarette Battery Failures Fire Control & Explosion Issues

Agriculture Tractor & Equipment Accidents Chemical Applications & Exposures Crop Storage & Harvesting Accidents Pesticides Construction Vehicle Visibility Accidents Slip, Trip, & Fall Accidents Power Tool Repetitive & Immediate Injuries Scaffolding - Cranes - Hoisting - Fork Lifts Insurance Subrogation & Forensics Accident Investigations Electrical & Fire Causation Chemical Leakage Damage Defective Equipment Injuries Premise and Process Damages

James M. Miller, PE, PhD – Founder  Dr. Miller is an Emeritus Engineering Professor at the University of Michigan. He has directly served in Washington originating several Federal OSHA safety regulations, and interacts regularly with CPSC regarding safety and product recalls. Dr. Miller often works on projects relating to compliance with occupational safety standards, provides upper management guidance on product design, recall and liability issues, and serves as an expert witness.

Mark R. Lehto, PhD – Co-Founder Dr. Lehto is a Professor of Engineering at Purdue University. He completed his Ph.D. in engineering at the University of Michigan, where he specialized in Human Factors Engineering, in particular Warnings and Labeling. Dr. Lehto specializes in knowledge engineering, warnings and instructions, structuring expert systems, accident modeling, accident statistical analysis, consumer product safety, boating safety, in-field national surveys of product usage, and product information effectiveness.

David R. Clark, PE, PhD – Co-Founder Dr. Clark is an Emeritus Engineering Professor at Kettering University. He was an engineering PhD graduate from the University of Michigan, where he specialized in human factors engineering and system safety analyses. He has a special expertise in electrical fire- and explosion-related accidents, and has extensive experience working for loss control companies, performing over 150 fire origin and cause investigations in the past few years.

Adam M. Olshove, PE, MSE – Engineering Manager Mr. Olshove has over 10 years of experience providing consulting services to industry and the legal profession. He holds an MS in Mechanical Engineering with a focus on control systems and battery modeling (2019), and a BS in Mechanical Engineering (2012), both from the University of Michigan. He has performed dozens of on-site investigations nationwide in relation to consumer product design and industrial accidents, including failure analysis and testing.

Jeffrey D. Rupp, MSE – Engineering Associate Mr. Rupp has a BS in mechanical engineering from the University of Michigan and a MS in systems engineering and engineering management from Wayne State University. Among his company affiliates is 26 years with Ford Motor Company and Volvo Car Corporation, where he was involved in crash development and crash sensing calibrations.

John L. Ryan, BSME, P.E. is a Mechanical Engineer who provides general Mechanical and Structural Engineering expertise. Mechanical and Safety Engineering (MASE) provides full service analysis and accident reconstruction of products involved in accidents. 

Mr. Ryan's services have been requested for attorneys and insurance companies needing forensic engineering expert witness testimony to determine whether machinery and products involved in injury cases were adequately designed or whether they have a Design, Manufacturing, or Material Defect. All products are lab-tested on site to determine adherence to industry standards and engineering design protocol. Alternate preventative designs are developed when none exist commercially. 

Mr. Ryan is available for both Plaintiff and Defense, depending on the individual case. His services include producing high quality reports and visual aids in the courtroom such as scale models to help explain accident scenarios and alternate designs to judges and juries. 

Areas of Expertise:

• Accident Investigation and Reconstruction
• Machine Guarding Accident Investigation
• Climbing Gym Accidents
• Belay Device Failure
• Rock Climbing Accidents
• Fall Protection Failures
• Ladder Failure Investigation
• Design Defect Analysis
• Structural Analysis of Buildings
• Product Liability Investigations
• General Engineering Injuries and Issues
• Industrial safety
• Engineering Continuing Education
• Product Certification

View John Ryan's Consulting Profile.

Claire K. Sand, PhD, is a Global Packaging Technology  Leader with over 35 years of Food Science and Packaging experience. 

Dr. Sand is the owner and founder of Packaging Technology and Research, LLC.   She is also an Adjunct Professor at Michigan State University and CalPoly, and a monthly contributor to Packaging Digest. 

Dr. Sand's background includes working with Total Quality Marketing, Nestle, General Mills, Kraft Heinz, Safeway, and academia, as well as in basic research, development market research, and marketing in Germany, Colombia, and Thailand.

She is an IFT Fellow, a recipient of the Lifetime Achievement in Food Packaging Award , a member of numerous Editorial Boards, the author of the Packaging Value Chain, and is in several leadership positions.

Litigation Support - Dr. Claire Sand is an experienced food packaging expert witness for attorneys representing plaintiff and defendant. Claire has served as an expert witness in 18 cases since 2016, involving 8 patents, 4 food packaging and food spoilage cases, and 6 other cases.

Her cases include Food and Beverage, Packaging and Labeling, and Patent and Intellectual Property litigation and lawsuits. Dr. Sand is available to consult, construct and write expert reports, serve as expert in depositions and testify.

Areas of Expertise:

• Patent Infringement and Invalidity - including patent infringement, patent invalidity, forensics related to patents and related lawsuits, design and utility patent infringement, food packaging patents, Patent or design infringement
• Trademark, Trade Dress or Trade Secret Disputes
• Food Package Interactions - including food damage and spoilage, food packaging safety, foods and how packaging interacts with food,
• Food Package Design - including flexible film, rigid packaging - bottles, cans jars, etc., semi-rigid packaging- foam trays, Food packaging product development, Integrity of packaged goods for warehousing
• Food Package and Packaging Forensics  - including failure analysis, defective packaging
• Material Science - including paperboard, polymers and plastics
• Probable Cause in Food Packaging Contamination
• Food Package Testing
• Food Packaging FDA Regulations & GMPs
• Food Packaging Machinery / Line Operations

View Packaging Technology Consultants' Business Consulting Profile.

ERIC P. ROSE, NPDP, MBA, Product Design and Manufacturing Expert Witness for Consumer, Medical, and Industrial products.

 Product Liability, Commercial Dispute, Patent Infringement  services provided to plaintiff and defense attorneys.

BACKGROUND: 35+ years' experience in product design, product development, product testing, and manufacturing. Product innovation part-time academic since 2009. Certified New Product Development Professional (NPDP) since 2008. Member of: PDMA, SPE, ASQ. Public Speaker since 1985.

BS Product Design, ASU College of Engineering. MBA, Pepperdine University, Named inventor on numerous patents issued and pending worldwide, https://bit.ly/2UyCa4N  

Deposed as a product design expert witness 4 times since Spring 2020 including twice in the 3M military earplug MDL. Daubert ruling at, https://bit.ly/EPR-3MEP-Daubert (Page 98). 

Expert witness services at, https://bit.ly/PDEWS 

Expert witness testimonials at, https://bit.ly/EPR-EWT

AREAS OF EXPERTISE:

Product Development Product Design ISO 9001 Manufacturing  Design For Manufacturing (DFM) Plastic Product Design Personal Protective Equipment (PPE) Respiratory Protection N95 Masks

Hearing Protection / Earplugs Industrial Products Dental Devices Medical Devices Consumer Products Toys Durable Medical Equipment (DME) Furniture FMEA

View Pinnacle Product Innovation's Consulting Profile.

Dr. J. P. Purswell, PhD, PE, CPE has extensive experience in Human Factors, Ergonomics, and Safety Engineering. He holds a doctorate in Industrial & Systems Engineering from Virginia Tech. He has taught Safety Engineering and Ergonomics in the Industrial Engineering Department at CSU-Pueblo since 1999. 

A member of the Human Factors and Ergonomics Society and the American Industrial Hygiene Association, Dr. Purswell also served as the Chair of the Industrial Engineers PE exam from 2005 to 2009. He continues to serve on the committee which is responsible for the preparation of the national professional engineering examination in industrial engineering. 

Dr. Purswell is the author of more than 20 publications and presentations on Product Safety, Occupational Safety, Printed Warnings, and Auditory Warnings. Examples of products addressed include silica, asbestos, cleaning chemicals, gasoline containers, and recreational equipment. Dr. Purswell maintains NIST-calibrated equipment for the measurement of light, sound, force, and whole-body and hand-arm vibration in addition to standard photo and video equipment. 

Litigation Support - An Expert Witness in the legal industry since 1997, Dr. Purswell has been qualified as an expert in state and federal courts across the nation in safety engineering, including safety analysis techniques such as Fault Tree Analysis and FMEA as well as product warnings / instructions and OSHA compliance issues. His services include site inspections, document review, drafting Rule 26-compliant reports, deposition, and trial testimony. He has been retained by attorneys for both Plaintiff (40%) and Defense (60%) more than 100 times, has been deposed approximately 50 times, and has testified at trial over 20 times. 

Areas of Expertise:

Warning and Safety Instructions OSHA Compliance Chemical Accident Prevention Product Safety Lockout / Tagout & Machine Guarding Trucks and Forklift Accidents

Power Tools Safety Hazard Communication - Audible Alarms Employer Safety Training and Supervision Perception / Reaction Time Ergonomic Work Practices Working and Walking Surfaces - Slip, Trip and Fall

View Dr. Purswell's Consulting Profile.

Quality Forensic Engineering, LLC is a full-service forensic engineering firm, providing engineering support to clients in the areas of accident reconstruction, biomechanics, fire investigations, patent litigation analysis, premises liability, product liability, and tire failure analysis. We use the latest technology and industry proven techniques to provide thorough analysis and conclusions for the most difficult engineering questions. Our forensic engineers support clients throughout the U.S. Headquartered in Tallahassee, FL, we have locations in Jacksonville, FL; Melbourne, FL; Tampa, FL; Indianapolis, IN; New Orleans, LA; San Diego, CA; Charlotte, NC; Columbia, SC; and Tucson, AZ.

Dr. Brian Pfeifer, PhD, PE - Dr. Pfeifer is an Engineering Expert with over 25 years of experience investigating thousands of cases involving a variety of forensic engineering issues. He is a leading expert in accident reconstruction, roadside safety, maintenance of traffic, commercial vehicle accidents, pedestrian accidents, bicycle accidents, and the analysis of mechanical systems and product failures. Dr. Pfeifer has a strong background in the design, development, and implementation of roadside safety hardware including guardrails, bridge rails, and crash cushions. Over 33 patents have been filed worldwide on behalf of Dr. Pfeifer and associated colleagues who invented safer guardrail systems, vehicle storage systems, shipping container handling systems, and material handling and storage methods. He has also utilized his technical knowledge and understanding of patents to assist in a number of matters involving patent litigation.

Dr. Pfeifer has published numerous papers to various organizations, covering topics such as new guardrail systems, energy absorbing guardrail terminals, breakaway sign mechanisms, and material handling technology. He has shared his expertise with many organizations on topics including vehicle collisions, bicycle accidents, roadway construction zones, and accident reconstruction expert witness utilization. Dr. Pfeifer is a registered Professional Engineer in nine states and he continues to refine his skills and knowledge of accident reconstruction and roadside safety by staying current with new technology and best practices. Dr. Pfeifer has extensive experience with providing deposition and trial testimony as an Engineering Expert. See Full Bio & CV.

Expertise:

Automobile Collisions Tractor-Trailer Collisions Guardrails / Bridge Rails Construction Zones Bicycle Accidents Pedestrian Accidents Motorcycle Accidents Occupant Kinematics

Roadside Safety Airbag Control Module (ACM) Analysis Tractor Trailer Electronic Control Module (ECM) Analysis Product Failure Analysis Maintenance of Traffic (MOT) Evaluation Restraint System Analysis Patent Litigation Technical Analysis

Dr. Ian M. Zeller, PhD, ACTAR, is an accomplished engineer with more than 10 years of experience in Biomechanics and Computational Dynamics fields. He has investigated hundreds of cases ranging from motor vehicle accidents, recreational incidents, medical device designs, as well as injuries from product liability all across the United States. 

Dr. Zeller has graduate level experience in computational dynamics and orthopedic biomechanics with a specific emphasis in dynamics, vibrations, joint contact mechanics, and muscle control during static and dynamic loading applications. Dr. Zeller’s past research includes clinical and computational analysis of the human body with respect to the design and implantation of orthopedic devices for the knee, hip, and spine. He has published in peer-reviewed journals and presented research at both technical and surgical conferences in North America, Europe, and Asia. Dr. Zeller also worked with surgeons across the United States in the design and assessment of knee replacement devices, including personalized and prototype devices to optimize for efficacy and safety. 

Dr. Zeller is also accredited as a traffic accident reconstructionist and continues to conduct research as well as maintain a current knowledge of developing trends and best practices in the biomechanics and engineering fields. Dr. Zeller has published to various organizations on topics ranging from knee replacement design, forward solution modeling, joint mechanics, personalized joint replacements, material structures and properties as well as biological modeling of disease distributions. He also has an extensive testifying history including depositions, trials, and arbitrations.

 See Full Bio & CV.

Expertise:

Biomechanical Analysis Accident Reconstruction Injury Consistency Mechanism of Injury Analysis Vehicle Occupant Kinematics Falling Object Mechanics and Analysis Bicycle Accidents Pedestrian Accidents Amusement Park and Playground Accidents Crash Data Retrieval and Analysis

Product Failure Analysis Seat Belt Analysis Restraint System Occupant Position Determination Sequential Events Analysis Speed Analysis Vehicle Damage Consistency Collision Avoidance Material Fracture Analysis

Michael R. Hill, PhD, PE, is a Biomechanical Engineer passionate about applying biomechanics techniques to solve diverse problems in forensics, medical research, engineering, biology, science, and mathematics. He is an expert in experimental, theoretical, and computational Tissue Biomechanics, with a focus on injury mechanisms, human tissue damage, and nonlinear soft tissue mechanics.

Dr. Hill’s core strengths are in orthopedic and cardiovascular biomechanics, vehicle accident reconstruction, injury consistency analysis, mechanical design, instrumentation, experimental analysis, numerical methods, simulation, statistics, and image processing. Dr. Hill has lectured in the field of biomechanics and numerical methods, and his research has been published in 16 academic articles and presented at 40 international and national scientific conferences.

See Full Bio & CV.

Expertise:

Vehicle Accident Reconstruction Occupant Kinematics Orthopedic and Cardiovascular Biomechanics Human Tissue Damage Mechanics Slip, Trip, and Fall Analysis Injury Consistency Analysis Statistics

Computational Mechanics  Experimental Biomechanics Image Analysis Mechanical Design Event Date Recorder (EDR) Data Retrieval and Analysis Automobile Restraint Analysis Numerical Methods

View Quality Forensic Engineering's Industrial Forensic Engineering Expert Witness Profile.

R. Kevin Smith PE, BSME, MMAE, has been a specialist in Engineering Forensic Safety and Design for 35 years. He has consulted on over a 1,000 matters nationwide. Mr. Smith is a registered professional engineer and holds a BSME and MMAE from the Illinois Institute of Technology in Chicago. He is board certified forensic engineer through the National Academy of Forensic Engineers. He specializes in Material Handling Equipment Safety, including lift trucks, dock safety, truck loading, conveyors, and aerial work platform safety. Mr. has been actively involved as a member of the committee that writes the Safety Standard for Low Lift and High Lift Trucks (ASME/ANSI B56.1) for over 30 years. He also serves on the B56.6 committee (rough terrain lift trucks) and the ANSI A92.5 and A92.6 subcommittees (self-propelled elevating work platforms). Litigation Support - Mr. Smith formerly worked for Triodyne, Inc. for over 15 years as a forensic engineer/principal engineer. As President of R. K. Smith Engineering Inc., for over 25 years, he currently has a laboratory for examination and testing, and owns or has access to varied testing equipment and tools. Kevin Smith has testified at depositions and trials on several hundred matters. He has performed hundreds of investigations into product failures involving injury and property damage, and has reconstructed numerous accidents. His expertise is available to counsel representing both Plaintiff and Defendant. Mr. Smith also was previously on the Adjunct Math faculty at Prairie State College for 13 years. Areas of Expertise:

Forklift Trucks Aerial Work Platform Lifts Product Testing Material Handling / Lifting / Rigging Equipment Accident Reconstruction Machine Guarding Safeguarding Warnings

Agricultural and Construction Equipment Skid Steer Loaders Stability Testing Loading Dock Safety Consumer Products / Testing OSHA Citations Codes & Standards Standard of Care in Design

View R. Kevin Smith's Consulting Profile.

Expert Background: Dr. Thomas L. Read is the Principal and CEO at A. Read Consulting, LLC. He received his PhD. from Stanford University in 1972 and has over 25 years of manufacturing experience in electronics, metallurgy, factory safety, failure analysis, glass fracture, glass failure and bottle failure. As a member of the electronics industry, he has earned process patents and has an extensive background in manufacturing techniques.

In parallel, Dr. Read has spent over twenty five years as a consultant to attorneys and engineers. He has given more than 100 depositions and has appeared in court numerous times.

Company Profile: Read Consulting, LLC is a full service laboratory providing services in the following areas:

Failure Analysis; Factory Safety and Personal Injury (including machine guards and manufacturing safety)

Glass Failure Analysis - Glass Fracture, Glass Failures and Bottle Failure

Metal and Ceramic Failure

Grinding Wheel Failures

Intellectual Property and Patent Disputes

Product Liability and Product Quality

Manufacturing Disagreements (such as Intellectual Property, Failed equipment and Contract Disputes)

Reverse Engineering

Christopher M. Daft, PhD, is an award winning, Oxford Educated scientist whose areas of expertise include medical imaging, artificial intelligence, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. He holds 23 United States Patents with 20 applications pending, Dr. Daft has diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung, and Siemens as well as several start-ups. 

He has testified at trial 5 times and been deposed 14 times.

Dr. Daft has been an Institute of Electrical and Electronic Engineers (IEEE) Senior Member since 2004. He has three years of experience teaching electrical and computer engineering at the University of Illinois. 

Dr. Daft holds a BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

Litigation Support - Dr. Daft provides litigation support in the areas of Intellectual Property and Medical Devices including Imaging, particularly Medical, Patents, and more. His experience includes a variety of cases in the areas of wearable electronics, imaging systems, and surgical technology. Dr. Daft has extensive deposition and trial testimony experience.

Areas of Expertise:

Design Engineering Electrical Engineering Electromagnetic Engineering Microelectronics Medical Imaging Electronics Semiconductors

Medical Devices Sensors Software Engineering MEMS Signal Processing Image Processing Physics

View Dr. Christopher Daft's Consulting Profile.

More than 40 years experience: defective packaging; unreasonably dangerous products; failure-to-warn; materials-handling; warehousing; cargo loading and securement; falling cargo; insurance claims for loss or damaged cargo; falling merchandise; patent infringement; trade-dress infringement. Has testified in state and federal courts and knows how to connect with a jury. Has worked for Plaintiffs and Defendants. Services: consulting; analysis; cite inspections; exemplar testing; opining; report writing; testifying. Long list of attorney references. Self-employed consultant. Former employee at Fortune 100 firms. Former university instructor. Many published articles and speaking engagements. Knows how to combine theory and practice.

Thomas W. Caldwell, PE, has over 40 years of experience in Materials Research and Development, Process and Product Development, and Manufacturing Operations in the Precision Cast and Machined Products industry.

Mr. Caldwell has designed and manufactured components for consumer and industrial products, including safety-critical applications such as aircraft landing gear brakes, seat belt lockup devices, windshield wiper, and window lift motor systems. He has experience creating and guiding technology development and manufacturing partnerships in Europe and Asia, licensing and selling intellectual property and creating supply chains in China.

Mr. Caldwell has lectured in the USA, Germany, Switzerland, and India on manufacturing premium quality metal products and manufacturing processes, and was a technical paper peer reviewer for 20 years for the Society of Automotive Engineers. A United States patent holder, he has published peer reviewed research in electrochemistry and materials processing, and has written and spoken numerous times on the subject of Materials Selection.

Litigation Support - Thomas W. Caldwell, PE, is a testifying and consulting expert for both plaintiff and defense counsel. His cases involve product failure for ferrous and non-ferrous alloy products such as hand tools, recreational and exercise equipment, fire fighting apparatus, rotating industrial machinery, construction hardware, piping, and lighting fixtures. Mr. Caldwell utilizes destructive and non-destructive methods for insuring product integrity.

Areas of Expertise:

Design Engineering Materials Failure Analysis Materials Engineering Mechanical Engineering Metallurgy Power Tools Products Liability Design Defects

Manufacturing Defects Fitness for Use Equipment Operation and Maintenance Accident Reconstruction Material Selection Manufacturing Process Design and Scale Up Safety Component Product Quality Control Safety Component Quality Systems Management

View Thomas A. Caldwell's Consulting Profile.

Susan Maccoy is an actively practicing Cosmetologist and experienced Expert Witness on Beauty Salon and Spa Products, Processes, Procedures, Policies and Standards. With over 45 years of experience, Ms. Maccoy combines an extensive background and foundation of knowledge in cosmetology and salon business and operations with critical and analytical thinking to provide solid, informed support for litigation. She was a salon owner and has been a manager of independent and franchise chain salons. She holds current cosmetology licenses in Illinois and Florida. Ms. Maccoy has assisted the legal profession on issues related to the cosmetology, beauty salon, and spa industries for over 35 years. Her expertise and professional experience encompass the full range of cosmetology products, services, techniques, and salon management. Ms. Maccoy also provides valuable insight for cases involving consumer and employee personal injury, product liability, professional liability including salon/spa customer injury,and allegations of discrimination in the salon and spa. To date,(2022) Ms. Maccoy has been retained by the defendant in approximately 30% of her engagements and by the plaintiff in 70%. In 2011, her investigative work and expert opinions were instrumental in obtaining dismissals with prejudice in two actions, one in state court and one federal. Zoom Conferencing   Available.Areas of Expertise:

• Salon Policies and Procedures
• Cosmetology Standards of Care, Processes, Procedures, Timelines, Workflow Protocols
• Salon / Spa Incidents and Injuries
• Salon / Spa Incident Investigation and Re-Creation - Chemical Formulations and Usage
• Salon Contractual Agreements - Employment, Rental, Salon Rental / Sale, Independent Contractor / Booth Rental
• Certified in Milady Salon Infection Protocols 2020
• Certified Covid 19 Protocols for Salons and Spas 2020 (Barbicide)

In her book, Down the Shampoo Bowl - The ABC's of Hair Salon Management, Ms. Maccoy explains the management and financial side of the beauty business and how to motivate employees, handle difficult clients, and promote business and services through traditional channels and social media. View Consulting Profile.

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to  resolve Form 483, Warning Letter, and Consent Decree issues.    

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness  and consultant to litigation in over 20 cases in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.

Henry W. Stormer, IAAI-CFI(V), CFPS, is the President / National Manager for VERTEX FIRE INVESTIGATIONS LLC, a wholly owned subsidiary of The VERTEX COMPANIES LLC. His responsibilities include management of a forensic fire investigation team conducting Fire Origin and Cause Investigations nationwide for the insurance industry.

Mr. Stormer has over 37 years of experience investigating in excess of 2,300 fires and explosions both in the public (25 years) and private sectors (12 years). He is a Certified Fire Investigator through the IAAI and a Certified Public Fire and Life Safety Instructor, with both certifications recognized by the National Board on Fire Service Professional Qualifications. He is also a Certified Fire Protection Specialist through the NFPA.

Litigation Support - Mr. Stormer has served as an expert witness and is actively engaged in several legal cases related to property damage, product liability, personal injury, and criminal activity. Mr. Stormer's legal support activities have included depositions, interrogatories, mediation, arbitration, and trial testimony.

Areas of Expertise:

Fire Origin and Cause Explosions Incendiary Fires Product Liability Household Appliances / Hood Systems / Dryers Photovoltaic Arrays and Battery Storage Systems Large and Complex Fire Scenes

Vehicle Fire Investigations Subrogation Failure Analysis Evidence Collection and Preservation Fire Code Analysis and Research Crime Scene Investigations Arson Investigations

Mr. Stormer is currently licensed as a Private Investigator, Manager in: AL, CT, DE, FL, IN, KY, MD, MA, MI, NH, NJ, NY, OH, SC, TX, VT, WV with reciprocal licensing in: AL, CA, GA, LA, NC, TN and VA.