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Journals and Conferences
Two manufacturing standards are discussed and compared, namely, the U.S. Food and Drug Administration's Good Manufacturing Practices and the International Standards Organization 9000 (ISO 9000) series. Conclusions are drawn relative to quality improvement strategies.
BACKGROUND Laser use in medicine is rapidly expanding as patients seek treatment for medical and cosmetic purposes. Concern is mounting about the unsupervised use of lasers and similar devices by nonphysician personnel. Minnesota is currently one of the few states with no legislation regarding the uses of lasers. OBJECTIVE To determine whether laser… (More)
Increasing regulatory and product safety standards along with the enhanced expectations of today's consumer public have dramatically changed the manner in which new biocides are researched, developed, and marketed. Potential candidates face ever rising quality hurdles regarding Product Efficacy, Toxicology, Human Health and Environmental Risk Assessment and… (More)
Manufacturers of biocides recognize a need to control the risk from their products. This paper discusses some of the history and critical aspects of these activities and outlines the needs under the current initiatives of Responsible Care. Biocide product safety risk assessment is operationally defined in this context and presented as the fundamental tool… (More)
All industrial countries, and several emerging and developing countries, have established regulations to control chemical substances, with a view toward limiting the risks to workers and the public, as well as reducing the impact on the environment. However, the lack of harmonization among such international schemes is creating international trade… (More)
Quality improvement initiatives for a corporate toxicology group require a high level of managerial commitment to a bring about lasting change, a well-enunciated plan, professional training, effective communication, and reward and accountability systems. Learnings are shared which should be applicable to other toxicology or corporate staff groups.
Effective training is key to quality improvement activities and should be organized as a system which integrates core company principles, has high professional standards, is appropriate to the technology, has management support, and meets employee needs. This paper deals with a training and awareness program required for quality assurance systems in the… (More)
One cannot manage a health or environmental risk of unknown dimension. Thus, the rational and cost-effective control of any risk lies first in its reasoned assessment. The assessment of risk is a scientific endeavor which embodies the intellectual use of information to reach a determination or assignment of an ascribed level of danger. It is, however, a… (More)
The Toxic Substances Control Act (TSCA) empowers the Environmental Protection Agency (EPA) to regulate risk associated with the use of existing chemicals and the introduction of new chemicals into commerce. Due to a number of concerns, however, the authority to regulate existing chemicals under TSCA has enjoyed limited success. A more generic and flexible… (More)
The presentation of consistent hazard information in the face of conflicting inter- and intranational regulations and standards is a formidable task. The principal challenge arises from the varying definitions of what is and is not a hazardous chemical and the differing rules that regulate the disclosure of components on material safety data sheets (MSDS)… (More)