Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 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 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, 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 the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.
George Schiro is a DNA Technical Leader - Forensic Scientist. His duties include incorporating the DNA Advisory Board (DAB) standards, accountability for the technical operations of the lab, conducting DNA analysis using the 13 STR core loci and Y STR in casework, DNA research, forensic science training and crime scene investigation.
Mr. Schiro has worked over 3500 cases and has qualified as an expert over 175 times in 31 Louisiana parish courts, Arkansas, California, Florida, Mississippi, Missouri, Nevada, New York, Texas, West Virginia, federal court, U.S. court-martial, and two Louisiana city courts. Has also consulted on cases in 29 states.
In 1989, I heard Dr. Henry Lee speak at a homicide conference in Metairie, Louisiana. Dr. Lee is currently the Connecticut Department of Public Safety Commissioner and, perhaps, the most famous forensic scientist in the world.
One specialized operation that is routinely abused is the crime scene operation. From small police departments to large law enforcement agencies, the biggest problem with crime scene operations is the presence and interference of non-essential personnel at the scene. The law enforcement agency’s administration should deal with this and other crime scene investigation problems through effective crime scene management.
Dr. Ewen Todd is a Food Safety Expert with over 45 years of knowledge and experience in general food safety and Food Microbiology Issues. Specifically, he has extensive 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 work with the industry and his knowledge of foodborne disease, 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. He has worked in numerous countries educating and training, and collaborating to set up surveillance systems, food safety policies, regulations, and HACCP and other control strategies, including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, and Europe, as well as Canada and the USA. He is also familiar with food defense and food fraud issues, and waterborne disease. He is familiar with the US and Canadian food industry, both foodservice and food processing, HACCP, disease investigation, food, and equipment contamination.
Since leaving the Canadian government and entering academia and as a consultant, he has been an expert witness in 25 cases in both the U.S. and Canada where foodborne illnesses have occurred. He has testified on the behalf of plaintiffs who suffered from E. coli O157:H7, Campylobacter, Salmonella, ciguatoxin fish poisoning, yeast, and unknown agents. He has also represented defendants in two illness cases. Therefore, his litigation services are available for both Plaintiff and Defense.
Areas of Expertise
General Food Safety and Spoilage Issues
HACCP and GHP Systems
Standards for Poultry
Listeria Monocytogenes in Soft Cheeses
Standards for Poultry
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Dr. Olen R. Brown, PhD is a board certified Diplomate in Toxicology and member of the standards of knowledge committee. He has the PhD in Microbiology With over 35 years of experience in Life Sciences and more than 150 publications. Dr. Brown specializes in complex, multidisciplinary cases, and he focuses on Human Medicine using the disciplines of bacteriology, virology, immunology, epidemiology, biochemistry, physiology, analytical chemistry, toxicology, and environmental sciences.
Dr. Brown has provided litigation support services for 180+ cases in 25 states and 1 in Canada. Dr. Brown has served in Plaintiff/Defense, and Criminal/Civil cases. He has testified in 20 trials and 31 depositions. Dr. Brown's expertise include: cause-and-effect determination after medical record review; risk assessment and causation determination from toxic exposure; evaluation of the therapeutic and harmful effects of ethical drugs, antibiotics, alcohol, and drugs of abuse; the toxicity of solvents, pesticides, heavy metals, ozone, carbon monoxide, particulates, and most organic chemicals for most organ systems including the lung (Asthma, COPD, RADS) and the brain (Parkinson's), Dr. Brown has evaluated human medical and veterinary medical devices and pharmaceuticals for safety.
Attorneys use experts in two ways. First is the traditional use of an expert as a witness in court. In this role, scientists, business people, or others with technical knowledge are retained by attorneys primarily for their opinions (oral, written, or both), ultimately to be given at deposition and in civil and criminal courts. Second, the expert may be used as a pre-trial consultant or more specifically as an undisclosed consultant
"Miracles" reveals truth from Scripture, science and life. Everything that is or was or is to come is part of God's miracle. Science says that nothing is miraculous- Time and Chance created the universe with no meaning or purpose. God's universe has great meaning extending from the stars to atoms and to you. What we believe about miracles can be a source of great joy or missed joy in our lives. Dr. Brown, a Christian and author of over 100 scientific papers, has coined a new word, synscicretism, to call attention to the doctrine that today elevates science above religion. Science works best for the great "how" questions, but poorly for the great "why" of all things.
This authoritative guide is designed to achieve a synthesis of understanding and effort between case science and case law. It examines all stages of attorney/expert interaction from the initial interview to post-trial evaluation.