Product Safety Consultants: 19

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

Consulting Services: 

Global Regulatory Filing Review / Writing Agency Negotiation Strategic Advisories

Contracted Management Services Current Good Manufacturing Practices Compliance Quality Systems

View Timothy Anderson's Expert Witness Profile.

Susan Maccoy is a talented hair artist, image consultant, beauty educator and Consultant to the Professional Beauty and Hair Care Industry. As a consultant, she has been engaged by salon product manufacturers for product development, hair color formulation, hair color marketing, salon product and service marketing, as well as professional hair color and style education. As a master hair colorist, Ms. Maccoy played a leading role in the development of hi-lighting techniques using foil, and has trained professionals internationally in those procedures. As an educator, Ms. Maccoy has taught classrooms and lectured both nationally and internationally. She is the winner of Today's Chicago Woman Reader's Choice Award, the Clairol Hair Fashion Award, and Glemby International's Outstanding Achievement Award. Ms. Maccoy is also the creator and developer of the ProWorks™ Professional line of hair care products and ReikiRocks Spa Products™ and has consulted with such clients as Barbara Walters, Princess Diane Von Furstenburg, the Princesses Hussein of Jordan, and Lucille Ball among others. 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. Consulting, Testing, Product Development and Education Development:

• Clairol Professional, Inc.
• Helene Curtis
• Glemby International
• Alberto Culver
• Nancy Flynn Marketing Resources Inc.
• Lynch and Associates, P.C.

Special Appointments / Qualifications:

• Member, Clairol Presidential Haircolorists' Council
• Research consultant, American Longevity Research Institute
• Salon member, American Society for Aesthetic Medicine
• Advanced Accredited Educator, NCBTMB

View Expert Witness Profile.

Summit Associates of Bedford is a Materials and Manufacturing firm offering growth strategy, operations improvement, and international sourcing to commercial clients ranging in size from $3 to $150 million.

Summit Associates has a record of fixing troubled organizations and driving growth in complex technology based operations. Skilled at positioning small and middle market companies for sustained growth, they have commercial experience in ten countries, including creation and oversight of global partnerships in Europe and India and acquisition, sale, and licensing of fifteen technologies in seven countries.

Consulting Services:

Turnaround Leadership Organizational Change and Alignment Accelerated New Product / Market Development Product Launch

Lean Manufacturing Technology Acquisition Sale and Licensing International Partnerships Technology Valuation

Principal, 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.

View Thomas A. Caldwell's Expert Witness 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.

SepiSolar is a national solar-plus-storage design, engineering, and consulting company, where passion meets expertise in upholding the integrity of the Solar Industry. As fervent advocates for sustainable energy, we have positioned ourselves as the premier Business Consultants for solar-related matters. Our commitment to transparency, ethical practices, and cutting-edge knowledge has made us a trusted authority in the field. 

Joshua Weiner, NABCEP, founder of SepiSolar, leads a growing team of designers, engineers, and technical consultants. He is an experienced solar, energy storage, and micro-grid design and engineering executive and consultant with a demonstrated history of product, project, and business development success. Mr. Weiner is skilled in developing early-stage business units, new program / product implementation, project development, product design / integration, and scaling teams to address customer and market needs by deploying sustainable, clean, plug-and-play services and solutions. His expertise extends to residential, commercial, industrial, and utility scale markets as well as energy storage and solar microgrid technologies.

Consulting Services:

Solar PV Systems Financial and Technical Solar Engineering and Design Solar Batteries and Solar Storage Solar Microgrids Residential, Commercial and Utility Scale Solar

Project Management Technology Due Diligence Contract Structures Public Health and Safety Codes Municipal Permits Industry Codes and Standards

View Joshua Weiner's Expert Witness Profile.

Tom Jonaitis, DABT, is a Board Certified Toxicologist and Product Safety / Regulatory Consultant with 18 years of experience. He has broad expertise in the areas of Safety and Exposure Assessment, Regulatory Compliance, and Toxicology Evaluations.  

Mr. Jonaitis helps companies efficiently navigate and comply with various regulations and obstacles in the consumer product, food, cosmetic, dietary supplement, and chemical industries. His has co-authored several manuscripts in peer-reviewed journals on the topics of safety, risk assessment, and other research.

Background Experience - Prior to forming RegTox Solutions, Mr. Jonaitis served as Manager of Toxicology & Regulatory Affairs at Intertek Scientific & Regulatory Consultancy (2005-2018). He worked as subject-matter expert (SME) and client contact for matters related to California Proposition 65, including presenting webinars and presentations. He also conducted human exposure assessments in relation to chemicals in food, dietary supplements, consumer products, cosmetics, as well as deriving exposure limits for carcinogens, reproductive / developmental or other toxins using traditional and benchmark dose modeling approaches.

Business Consultant Services:

• Regulatory Compliance Evaluations
• Scientific Literature Hazard Reviews and Summaries for Chemicals / Substances
• Creating Pre-Market Quality and Safety Dossiers for Novel Food / Dietary Supplement Ingredient Applications (primarily for US, Canada, Australia)
• Safety Assessments
• Label Claims Analysis and Compliance
• Deriving Exposure Limits
• HazComm, Pesticide Applications, and various other niche areas
• California Proposition 65 Compliance (and how to avoid costly enforcement)

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

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 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., he currently has a laboratory for examination and testing, and owns or has access to varied testing equipment and tools. He has testified at depositions and trials on several hundred matters. Mr. Smith 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 is on the Adjunct Math faculty at Prairie State College. 

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 Expert Witness Profile.

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.

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.

James M.L. Miller, MS, PhD, EIT – Engineering Associate Dr. Miller is an Assistant Professor of mechanical engineering at Trine University in Angola, Indiana. Dr. Miller graduated with a Ph.D. degree in mechanical engineering and electrical engineering from Stanford University in 2021, advised by Dr. Thomas W. Kenny. At JMME he has applied his expertise to biomedical heat transfer problems and energy management in hydroelectric systems, solar arrays and portable battery usage.

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.

Harvey C. Voris is a Product Design Engineer with 35 years of proven experience in the Fitness Industry. Mr. Voris has designed and worked on approximately 200 fitness products and has been issued 7 U.S. utility patents. 

Consulting Services Include:

• Standards compliance evaluations of products, facilities and providers
• Design, analysis, and sourcing services for product concept through manufacturing
• Manual, warning, and documentation drafting
• Testing protocol design, testing apparatus design, and industry standard compliance verification

Mr. Voris has a Bachelors of Science in Engineering from UCLA with a specialization in Bio Structural Mechanics. His Masters in Engineering is from Cal State Long Beach where he specialized in Fatigue and Failure Analysis. Mr. Voris has spent 21 years devoted to the development and promotion of safety standards for the fitness industry. He has authored numerous standards and has chaired the ASTM committee devoted to fitness standards development since 1995. Mr. Voris has also delivered seminars on Fitness Safety Standards and Product Design topics both nationally and internationally. www.experts.com

View Harvey Voris' Expert Witness Profile.

Roger W. Griffith, PE, has over 37 years of professional experience as a Mechanical Engineer in the design, maintenance, and operation of mechanical systems. He specializes in the areas of Plumbing, HVAC, and Fire Sprinkler Systems Design.

Background - As the principal of Griffith Engineering & Consulting for 23 years, his design experience with commercial and industrial projects include convention centers, schools, office buildings, condominiums, apartment buildings, hotels, churches, manufacturing facilities, medical buildings, restaurants, historic buildings, dormitories, fire halls, and maintenance facilities. Prior to that, Mr. Griffith worked at the Tennessee Valley Authority (TVA) as a mechanical engineer for 14 years. 

His roles at TVA included nuclear piping analyst, valve and heat exchanger specialist, maintenance engineer, and later maintenance supervisor at a fossil plant, and quality manager. His engineering roles included failure analysis of plant equipment. He also taught many courses on the subject of problem-solving and failure analysis for company employees.

Consulting Services:

HVAC Design Plumbing Design Hot Water Systems Design

Legionella Outbreaks HVAC Design Carbon Monoxide Poisoning Sprinkler System Design

View Roger W. Griffith's Expert Witness Profile.

Dr. Kevin A. Rider, PhD, PE, CPE of Forensic Human Factors, LLC., providing forensic engineering and specializing in catastrophic motor vehicle collisions, illumination and conspicuity, driver behavior/attention/distraction, workplace safety, machine guarding, slips, trips and falls, and the adequacy of product warnings and instructions. His work focuses on identifying the Human Factors that lead to unfortunate incidents, and what should have been done to prevent them. 

Dr. Rider is a Licensed Professional Engineer and Certified Professional Ergonomist, and has studied human movements and behavior, and served as a human factors consultant since 1999, including five years teaching industrial engineering and occupational safety courses at West Virginia University. He has presented at professional conferences, both nationally and abroad, and his research is published and cited in a number of peer-reviewed journals. He continues to serve as a reviewer for conference and journal manuscripts. 

Dr. Rider has testified over 250 times, and excels at educating attorneys and jurors. His services are available to attorneys for both Plaintiff and Defense. 

• Over 35 years of experience in Mechanical / Structural Engineering & Design, Failure Analysis, Product Liability, Industural Asbestos,Pressure Vessel & Boiler analysis and evaluation of mechanical and structural components.
• Extensive trial experience. Has been involved in multi-million dollar cases. Areas involved included:

  
  

  - Piping & pipe supports - Structural failure of products - Failure analysis - Industrial asbestos - Seismic analysis - Fire protection - Pressure vessels

  - Tanks - Construction - Heat transfer analysis - Environmental qualification of equipment - Welding - Product design - Patent information

• Expertise in developing litigation rate-case exhibits and detailed supporting testimony, and in organizing case documentation into easy-to-use computer databases for trial use.

Dr. Box Consulting, Inc. is one of the highest respected consulting firms dedicated to the Packaging industry. Since 2010, it has become a globally renowned source for packaging process improvement, purchasing, manufacturing, distributing, shipment, and packaging environments. Dr. Box Consulting Inc.'s clients include Fortune 1000 corporations around the world and the Governments of the United States, Afghanistan, Tajikistan and the Country of Georgia.  

Business Consulting Services:

Packaging and Business Improvement - Waste reduction, quality improvement, safety improvement, profit improvement, lean manufacturing, machine productivity improvement, overtime reduction, on-time-delivery improvement and many other business improvement areas. A global leader in Packaging Procurement results.

Packaging Design and Branding - Assess packaging lines, improve efficiency, reduce material cost, design cost-effective packaging utilizing better and more flexible designs to protect and display products.

Branding - Design packaging, proper color choice, placement and designs of logos, names of products, placement of wording on the product and packaging for cosmetics, food products, household goods and many others. 

Packaging Research - Market assessments to determine the viability of building new plants in specific areas, including economic analysis, trend analysis, assessment of potential competitors’ strengths and weaknesses, market pricing analysis, and determination of potential customers.

Randy Phares, President and CEO of Dr. Box Consulting, Inc., is a Packaging expert specializing in Corrugated and Folding Carton Packaging. He has over 30 years of progressive leadership experience in Packaging, Procurement, Shipping, Lean Manufacturing, Quality, Safety, Productivity, and Business Improvement.

Since he began his career in 1990, Mr. Phares has held almost every job in packaging operations. These include manufacturing, distribution, sales, design, safety, and transportation.

Mr. Phares has served as a consultant for the Technical Association of the Pulp and Paper Industry's (TAPPI) Consulting Council. He was also the Vice Chair of the Packaging Consultants Council for the Institute of Packaging Professionals (IOPP) and President of the South Texas Manufacturer’s Association. 

Mr. Phares has spoken and keynoted National, International and Local conferences. He has been hired to do DOT Packaging HAZMAT training for paper, rigid, and flexible packaging. Mr. Phares has done leadership training, Lean Manufacturing training, sales training, machinery training, new Supervisor training, safety training, and much more.

View Randy Phares' Expert Witness Profile.

Peter Crosby has over 45 years experience in the medical device industry. He has served as CEO of six medical device companies in four countries (public and private), and brought many products to the world market through clinical trials and regulatory approval.

Through Biomedical Business Resources LLC, he provides many services including:

• Advisory - helping clients with strategy, operations, execution, and business building\
• Mentoring, especially first time CEOs
• Expert Witness - assisting attorneys with multiple expert reports, depositions, and testimony at trial and arbitration. Cases include disputes about intellectual property , product liability, and commercial contracts
• Board Services - offering Independent Board Member services for companies, public or private, with experience in building companies, and helping management teams in times of high growth and rapid change

Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostimulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.

View Peter Crosby's Expert Witness Profile.