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The below expert witness bios represent a small fraction of those Food Manufacturing experts known by Cahn Litigation Services. These bios are provided to give attorneys a sense of the Food Manufacturing landscape.
This expert is an experienced food and drug manufacturing standards expert. This expert set up over 250 Quality systems for compliance and /or certification, audited over 400 pharmaceutical and medical device manufacturers and participated in over 200 FDA audits of regulated companies for devices, food banks and other categories. This expert knows the laboratory environment and understands cleanliness / sterile requirements for the preparation and/or manufacture of food and drug products.
This expert is an Adjunct Professor of Food Science and Food Technology and is one of the world's foremost scientific experts in the field. Author of 10 books on a vast range of food and food packaging topics, recipient of over 40 awards and honors, contributor to numerous books, journals, and publications, and consultant to many of the world's largest packaging companies, this expert was inducted into the Packaging Hall of Fame. For many years this expert has taught food packaging courses to graduates and undergraduates at major universities. This expert received B.S. degree and Ph.D. degrees. Further, this expert is a consultant in food and food technology, packaging and marketing. This expert helped industry leaders develop the first microwave ovens, and manage an aseptic packaging system. This expert is author of hundreds of articles and eight textbooks in food and food technology, marketing and packaging. This expert is contributing editor for Food Technology, and Technical and Marketing Information Editor for Brand Packaging.
HACCP Stands for Hazard Analysis and Critical Control Point. HACCP is an internationally recognized system for reducing the risk of safety hazards in food. An HACCP System requires that potential hazards are identified and controlled at specific points in the process.
Following a career in the public and private sectors, this expert launched a consulting firm, serving as President and CEO and specializing in food safety and health policy, and regulatory science. This expert has had senior leadership roles in the public and private sectors. During this expert's career in the food industry, this expert served as a director in supply chain management and quality systems. In these roles, this expert was an integral player in the care and management of perishable produce from the vendor through to manufacturing or service in a restaurant. This expert worked closely with multiple companies and regulatory agencies in the safe handling, storage, transport, and service of fresh produce - including strawberries.
In addition to responsibilities for food safety, this expert had a leadership role in designing and reviewing traceability programs for food products in national and international transport in quality and food safety leadership roles; and as part of the development of Food Safety and Modernization Act (FSMA) regulations, Hazard Analysis and Critical Control Point (HACCP) systems, and ISO 9000 quality management systems. This expert reviewed various temperature tracking tools and used several different systems in various positions. Further, as a successful consultant, this expert has had to review procedures and data for temperature tracking; this expert is well familiar with the industry's needs and available tools for temperature control. This expert has worked with most commodities and is highly familiar with the standard shelf life of perishable food items, and the impact of temperature and humidity on food quality and safety.
Prior to joining the public sector, this expert worked for a regulatory agency for meat and poultry. There this expert led the global development for the principles of HACCP, and played key roles in the adoption of HACCP as a regulatory tool and the development of the Sanitary and Phytosanitary Standards. This expert has also worked for two science-based trade associations.
This expert received a doctoral degree, Masters of Science and undergraduate degree and is a
Registered Dietitian. This expert is also a Fellow of the Institute of Food Technologists.
This expert has extensive prior litigation experience including a significant number of depositions and one trial testimony.
This expert is primarily a food safety expert and as such has become familiar with regulatory requirements for clean and sterile laboratories and manufacturing/processing facilities. One of this expert's core expertise areas is the effectiveness of cleaning and sanitation programs
This expert holds a Ph.D. in Food Science, and is a flavor chemist. This expert created a soy-based milk marketed. This expert helped develop the flavors for plain, vanilla and chocolate flavors, worked with a flavor company to use soy taste-maskers and to have an improved vanilla and plain soymilk product based on the use of these flavoring agents. This expert worked with the flavor company to develop and prototype flavors, and help direct sensory testing. This expert worked a top 3 global flavor company developing new technology for dairy and beverages. As a consultant, this expert worked for a number of smaller flavor companies helping them develop flavor technologies.
This expert provides Expert Witness, Investigation, and Technical Consulting services for Industrial Control Systems, Automated Systems, and Safety Systems. This expert has litigated several cases that involve PLC ladder logic, and has designed scores of systems which utilize PLC code. This expert manages an automation engineering group, and writes/analyzes PLC code virtually every day. Experience includes:
Automated Machinery – Manufacturing Plants, Production Plants
Robotics – Assembly Lines, Semiconductor Plants, Packaging Plants
Control Systems – PLC Controls, Computer Controlled Machines
Automatic and Revolving Doors
Amusement Park Rides – Control Systems, Safety Systems
Bowling Centers – Equipment Systems
Mining – Surface and Strip Mining, Coal, Quarry, Minerals, Oilsands, Conveyors, and Crushers
Lasers – Etching Equipment, Production Lines
Egg Production and Packaging
Food and Beverage Plants – Snack Foods, Cereal, Pasta, Soft Drinks, Beer, Meat Packaging
Conveyors – Belt Conveyors, Bucket Conveyors, Packaging Machines, Vibratory Systems
Wood Production – Sawmills, Chippers, Wood Pellet Plants
Patents – Control Systems, Automated Devices, Production and Manufacturing Machines
Contract Disputes – Control Systems, Production Equipment, Manufacturing Equipment
This expert has acquired many years of experience in electrical, electronic, automation, robotics, bulk materials handling, and mechanical system design. As an inventor, this expert holds several electronic and mechanical patents. This expert’s technical background includes extensive experience with digital logic circuits, vision systems, laser research involving Co2 lasers (Class 4 100 watt), and laser diodes (Class 3B). This expert has established and managed several engineering, CAD, automation, and field service groups, for deployment of automated machinery in the food, beverage, refinery, coal, oil sands, pharmaceutical, and chemical plant industries. Most of this work carried over to the field, where this expert managed electrical and mechanical field construction projects.
This expert’s memberships have included ISA (Instrumentation, Systems, and Automation Society), and AEE (The Association of Energy Engineers). Authorships include Whitepapers for RAM (Remote Asset Management), Energy Management, Automation, and cGMP (Current Good Manufacturing Practice) for FDA related validation procedures in lab environments. Intellectual property and patent experience includes work as a Technical Expert Witness involving patent infringement and automation related accidents.
This expert is a Professional Engineer with an MS in Electrical Engineering. This expert has extensive experience in industrial controls, including developing ladder logic and source code. This expert has designed processing machinery, material handling systems, tooling, industrial controls, data acquisition systems, and safety interlocks for manufacturing lines. This expert has created mechanical drawings, electrical wiring diagrams, electrical schematics, and control logic. This expert has led seminars and continuing education workshops related to designing analog block logic, digital ladder logic for process control applications, human-machine interface (HMI) graphics, wiring, and hardware for distributed control system (DCS) applications. As a Consulting Engineering Manager, this expert managed intellectual property and regulatory compliance matters, and developed, designed, and tested digital and analog electronics, embedded systems, industrial control system logic, and mechanical components for the food, consumer product, medical device, transportation, utility, HVAC, and agricultural equipment industries. As Plant Engineer, this expert designed machine elements, tooling, and automated control systems for food production lines. This expert is the author of numerous technical and programming publications, is a patent holder, and has provided expert witness services for over 15 years, testifying in depositions and in the courtroom.
This expert is a Director in the FDA Regulatory practice of an internationally recognized consultancy. This expert's areas of expertise include review of promotional materials for products of all types, strategic analysis of regulatory pathways and laboratory developed tests. This expert also advises clients in the areas of informed consent, investigator disqualification proceedings, Form 483/Warning Letter responses, quality agreements, and good manufacturing practices. Additionally, this expert serves as an expert witness on FDA processes. This expert has decades of regulatory strategy and compliance experience in the Life Sciences industry in roles at a federal agency and in private legal practice. This expert is frequently called upon by clients to assist in navigating FDA regulations. This expert became very familiar with the premarket approval processes for all types of therapeutic products regulated by FDA. This expert has advised many manufacturers of regulated therapeutic products on the meaning and application of the Federal Food, Drug, and Cosmetic Act. Furthermore, since enactment of the Family Smoking Prevention and Tobacco Control Act this expert has advised clients who are manufacturers of:
- hookah, and
- traditional cigarettes
on the meaning and application of the Tobacco Control Act statutory provisions and FDA regulations and guidance documents.
This expert is familiar with FDA's interpretation of "predicate product" and "substantial equivalence" in the context of tobacco products, which is much narrower than the agency's interpretation of the same terms in the context of medical devices. In addition, this expert has advised e-cigarette and hookah clients on whether their products met the definition of a "new tobacco product" requiring the submission of substantial equivalence information to FDA.
This expert is a long-time Food and Drug Administration authority. This expert's current consulting firm is focused on FDA compliance, specifically the CMC (Chemistry, Manufacturing and Controls) section of the FDA submission which governs labeling, and exactly what quantities, purities, strengths and other specifications the applicant is allowed to bring to market. This expert possesses Regulatory, Technical and Management expertise in FDA compliance. This expert also holds two US patents and is well published in the field. This expert has served as an Adjunct Professor.