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FDA Regulation (Food Drug Administration) Consultants: 6

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Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience. Dr. Skaer's research and professional experience include pharmacy practice, chronic pain, mental health, substance abuse, and complementary and alternative medicine. She is licensed pharmacist in California, Idaho, and Washington.

Dr. Skaer’s current research involves the use of mindfulness and multiple family group problem solving for the Treatment of Chronic Pain in those with high risk of Opioid Use. Her plans are to expand this intervention to manage chronic insomnia and post-traumatic stress disorder in children and adolescents, American Indians, veterans, and other populations. Other research interests include chronic pain, comorbid mental illness in chronic disease, depression, anxiety disorders, insomnia, mindfulness, complementary and alternative medicine, and pharamcoeconomics and pharmacoepidemiology. Her research has been supported by over $3.2 million in grants from foundations and pharmaceutical industry.

Dr. Skaer has published 110 professional abstracts, 82 research papers, 43 review articles, and 6 book chapters. She serves on the editorial boards of 3 medical professional journals, Clinical Therapeutics, Journal of Sleep Medicine and Disorders, and Pain Studies and Treatment. Dr. Skaer's publications have appeared in numerous journals including, Drugs, Clinical Drug Investigation, PharmacoEconomics, Journal of Clinical Pharmacy & Therapeutics, American Journal of Medicine, Harvard Review of Psychiatry, and the New England Journal of Medicine among others.

View Dr. Skaer's Expert Witness Profile.

• Dr. Skaer's Curriculum Vitae

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Tom Jonaitis, DABT, is a Board Certified Toxicologist and Consumer 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, building material, 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)

• Tom Jonaitis' Curriculum Vitae

• RegTox Solutions Services

• Blog

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Packaging Technology & Research LLC provides Food Packaging Consulting, Tailored Packaging Science, and Value Chain Solutions that improve packaging in the Food and Beverage Industry.

Science-Based Consulting:

Problem Solving and Technical Consulting - Help uncover and shine a spotlight on what’s working and what is NOT to help our clients take bold steps rooted in science-based packaging expertise.

Sustainable Packaging - Unlock the optimal blend of food and packaging science, value chain experience, and consumer insights to achieve more sustainable packaging for clients. This includes food packaging system, flexible packaging, and packaging materials that support food packaging sustainability.

Increase Shelf Life and Prevent Food Waste - Empower clients with packaging solutions to prevent food waste, meet bold commitments on addressing UNSDGs, food justice, hunger, and GHG. reduction. F

Strategy and Roadmaps - Steer clients’ futures by developing science-based, systems-thinking strategies and roadmaps to ensure both an intelligent plan and a strong business case. From food packaging for frozen food to edible packaging and pet food packaging

Clients: Food Companies, Produce Companies, Frozen Food Manufactures, Meal Kit Delivery Companies, Food and Packaging Wholesaler, Restaurant Chains, Industry Associations, Packaging Companies, Bakeries, Pet Food Companies, Packaging Manufacturers, Quick Service Restaurants, Environmental Advocacy Groups, Chemical Companies, Dairy Farms, Butchers, Copackers, Meat Delivery Companies, Restaurants.

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

Dr. Sand is the owner and founder of Packaging Technology and Research, LLC, as well as Gazelle Mobile Packaging Inc. She is also an Adjunct Professor at Michigan State University and CalPoly. She is an IFT Fellow, the Riester-Davis-Brody Lifetime Achievement in Food Packaging Award recipient, a member of numerous Editorial Boards, the author of the Packaging Value Chain, and the co-chair of pacfoodwaste. Dr. Sand received her doctorate in Food Science and Nutrition from the University of Minnesota, as well as master's and bachelor's degrees in packaging from Michigan State University.

View Dr. Claire K. Sand's Expert Witness Profile.

• Dr. Claire K. Sand's Curriclum Vitae

• Biography

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One Way Consulting, LLC, is a Medical Device Consulting firm whose mission is to help get your device to the market sooner, to assure your quality systems meet FDA requirements, and solve any FDA issues in a timely and successful manner.

Consulting Services:

Create FDA Strategic Plans for Start Up Companies
Serve as Regulatory / Quality Mentors
Liaison at FDA to Solve Regulatory Issues
Perform MOCK FDA Audits to Assess Quality Systems

Prepare Responses to FDA-483 Observations / FDA Warning Letters
Review Design Control Operations for Required Elements
Evaluate CAPA Programs for Effectiveness and Compliance
Perform Webinars on FDA Issues / Provide Expert Witness Services

Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.

View Mr. Stevens' Expert Witness Profile.

• J. Lawrence Stevens' Curriculum Vitae

• Video Introduction

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mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

• View mdi Consultants, Inc. Partial Client List

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Dr. Ewen Todd is a Food Safety Expert with over 45 years of experience in the reporting and surveillance of Foodborne Disease, as well as development of analytical methods for identifying foodborne pathogens. As a result of his knowledge of foodborne disease and work researching different pathogens and toxins, Dr. Todd has influenced research programs and regulatory approaches taken by the Health Protection Branch of Health Canada. In the US, he held the position of Director of the National Food Safety and Toxicology Center and the Food Safety Policy Center at Michigan State University.

A leader in microbial research, foodborne disease surveillance, costing of outbreaks, food safety policy, seafood toxins, standard-setting, risk assessment, risk management and risk communication, his presentations and food safety programs have been influential in many countries including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, Europe, as well as Canada, and the USA. Dr. Todd has delivered over 400 presentations and posters at national and international meetings, with over 200 invitations to speak and teach workshops.

An acclaimed author in the field of Foodborne Illness, he has written 109 research papers, 16 reviews, 36 book chapters and booklets, 40 departmental publications, 37 conference proceedings, 9 laboratory methods, 56 investigational and editorial articles, 90 published abstracts, and 3 editings of proceedings or books. Dr. Todd has received 20 appointments and awards, including the Excellence in Science Award for 1998, the first to be awarded by Health Canada. He is a Fellow of the American Association for the Advancement of Science, the International Association for Food Protection and MSU University Outreach and Engagement as well as Editor in Chief for the Elsevier Encyclopaedia of Food Safety.

Dr. Todd's Consulting services are available to businesses and governments internationally. He responds to telephone calls, emails, and written requests for information on food and waterborne disease.

Consulting Services Include

General Food Safety and Spoilage Issues
HACCP and GHP Systems
Standards for Poultry
Listeria Monocytogenes in Soft Cheeses
Standards for Poultry
Seafood Toxins
Food Workers
Investigation of Foodborne and Waterborne Illnesses
Foodborne Disease Surveillance Systems
Risk Assessment, Risk Management and Risk Governance
Safety of Aquaculture Systems
Norovirus in Elder Care and Other Facilities
Salmonella and Shigella in Schools and Child Care Centers
Salmonella in Tahini and Other Oil-based Foods
Escherichia coli O157:H7 in Leafy Greens
Staphylococcus aureus in Cheese, Clostridium botulinum in Canned or Preserved Food and Native American / Inuit Fermented Food
Listeria monocytogenes in Deli Meats and Soft Cheeses
Controlling Listeria monocytogenes in Ready-to-eat Foods
Hydrophobic Grid Membrane Filter Systems

View Expert Witness Profile.

• View Dr. Todd's Curriculum Vitae

• Full Biography

• Peer-Reviewed Publications

9/26/2014 · Engineering

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 11. Use of Antiseptics and Sanitizers in Community Settings and Issues of Hand Hygiene Compliance in Health Care and Food Industries

By: Dr. Ewen Todd

Hand washing with soap is a practice that has long been recognized as a major barrier to the spread of disease in food production, preparation, and service and in health care settings, including hospitals, child care centers, and elder care facilities. Many of these settings present multiple opportunities for spread of pathogens within at-risk populations, and extra vigilance must be applied. Unfortunately, hand hygiene is not always carried out effectively, and both enteric and respiratory diseases are easily spread in these environments. Where water is limited or frequent hand hygiene is required on a daily basis, such as for many patients in hospitals and astronauts in space travel, instant sanitizers or sanitary wipes are thought to be an effective way of preventing contamination and spread of organisms among coworkers and others. Most concerns regarding compliance are associated with the health care field, but the food industry also must be considered.

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8/26/2014 · Engineering

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 10. Alcohol-Based Antiseptics for Hand Disinfection and a Comparison of Their Effectiveness with Soaps

By: Dr. Ewen Todd

Alcohol compounds are increasingly used as a substitute for hand washing in health care environments and some public places because these compounds are easy to use and do not require water or hand drying materials. However, the effectiveness of these compounds depends on how much soil (bioburden) is present on the hands. Workers in health care environments and other public places must wash their hands before using antiseptics and/or wearing gloves. However, alcohol-based antiseptics, also called rubs and sanitizers, can be very effective for rapidly destroying some pathogens by the action of the aqueous alcohol solution without the need for water or drying with towels.

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7/22/2014 · Engineering

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 9. Washing and Drying of Hands To Reduce Microbial Contamination

By: Dr. Ewen Todd

During various daily activities at home and work, hands quickly become contaminated. Some activities increase the risk of finger contamination by pathogens more than others, such as the use of toilet paper to clean up following a diarrheal episode, changing the diaper of a sick infant, blowing a nose, or touching raw food materials. Many foodborne outbreak investigation reports have identified the hands of food workers as the source of pathogens in the implicated food. The most convenient and efficient way of removing pathogens from hands is through hand washing. Important components of hand washing are potable water for rinsing and soaps to loosen microbes from the skin. Hand washing should occur after any activity that soils hands and certainly before preparing, serving, or eating food.

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6/12/2014 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 8. Gloves as Barriers To Prevent Contamination of Food by Workers

By: Dr. Ewen Todd

The role played by food workers and other individuals in the contamination of food has been identified as an important contributing factor leading to foodborne outbreaks. To prevent direct bare hand contact with food and food surfaces, many jurisdictions have made glove use compulsory for food production and preparation. When properly used, gloves can substantially reduce opportunities for food contamination. However, gloves have limitations and may become a source of contamination if they are punctured or improperly used. Experiments conducted in clinical and dental settings have revealed pinhole leaks in gloves.

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5/8/2014 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 7. Barriers To Reduce Contamination of Food by Workers

By: Dr. Ewen Todd

Contamination of food and individuals by food workers has been identified as an important contributing factor during foodborne illness investigations. Physical and chemical barriers to prevent microbial contamination of food are hurdles that block or reduce the transfer of pathogens to the food surface from the hands of a food worker, from other foods, or from the environment. In food service operations, direct contact of food by hands should be prevented by the use of barriers, especially when gloves are not worn. Although these barriers have been used for decades in food processing and food service operations, their effectiveness is sometimes questioned or their use may be ignored. Physical barriers include properly engineered building walls and doors to minimize the flow of outside particles and pests to food storage and food preparation areas; food shields to prevent aerosol contamination of displayed food by customers and workers; work clothing designated strictly for work (clothing worn outdoors can carry undesirable microorganisms, including pathogens from infected family members, into the work environment); and utensils such as spoons, tongs, and deli papers to prevent direct contact between hands and the food being prepared or served. Money and ready-to-eat foods should be handled as two separate operations, preferably by two workers.

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4/8/2014 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 6. Transmission and Survival of Pathogens in the Food Processing and Preparation Environment

By: Dr. Ewen Todd

This article, the sixth in a series reviewing the role of food workers in foodborne outbreaks, describes the source and means of pathogen transfer. The transmission and survival of enteric pathogens in the food processing and preparation environment through human and raw food sources is reviewed, with the main objective of providing information critical to the reduction of illness due to foodborne outbreaks. Pathogens in the food preparation area can originate from infected food workers, raw foods, or other environmental sources. These pathogens can then spread within food preparation or processing facilities through sometimes complex pathways and may infect one or more workers or the consumer of foods processed or prepared by these infected workers.

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2/28/2014 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 5. Sources of Contamination and Pathogen Excretion from Infected Persons

By: Dr. Ewen Todd

In this article, the fifth in a series reviewing the role of food workers in foodborne outbreaks, background information on the routes of infection for food workers is considered. Contamination most frequently occurs via the fecal-oral route, when pathogens are present in the feces of ill, convalescent, or otherwise colonized persons. It is difficult for managers of food operations to identify food workers who may be excreting pathogens, even when these workers report their illnesses, because workers can shed pathogens during the prodrome phase of illness or can be long-term excretors or asymptomatic carriers.

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1/27/2014 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 4. Infective Doses and Pathogen Carriage

By: Dr. Ewen Todd

In this article, the fourth in a series reviewing the role of food workers in foodborne outbreaks, background information on the presence of enteric pathogens in the community, the numbers of organisms required to initiate an infection, and the length of carriage are presented. Although workers have been implicated in outbreaks, they were not always aware of their infections, either because they were in the prodromic phase before symptoms began or because they were asymptomatic carriers.

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4/16/2013 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 3. Factors Contributing to Outbreaks and Description of Outbreak Categories

By: Dr. Ewen Todd

In this article, the third in a series of several reviewing the role of food workers in 816 foodborne outbreaks, factors contributing to outbreaks and descriptions of different categories of worker involvement are discussed.

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3/13/2013 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 2. Description of Outbreaks by Size, Severity, and Settings

By: Dr. Ewen Todd

This article is the second in a series of several by members of the Committee on the Control of Foodborne Illness of the International Association of Food Protection, and it continues the analysis of 816 outbreaks where food workers were implicated in the spread of foodborne disease.

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1/23/2013 · Food & Beverage

Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease - Part 1: Description of the Problem, Methods, and Agents Involved

By: Dr. Ewen Todd

Food workers in many settings have been responsible for foodborne disease outbreaks for decades, and there is no indication that this is diminishing. The Committee on Control of Foodborne Illnesses of the International Association for Food Protection was tasked with collecting and evaluating any data on worker-associated outbreaks.

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Business consultants

FDA Regulation (Food Drug Administration) Consultants: 6

Pharmacotherapy Consultant Tracy Skaer

Consumer Product Toxicology and Regulatory Consultant Tom Jonaitis

Global Packaging Technology Consultant Claire Sand

Medical Device FDA Compliance Consultant John Lawrence Stevens

FDA Consultant Alan Schwartz

Food Safety Foodborne Illness Consultant Ewen Todd

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