Satisfying regulatory requirements

The standard requires that all products or materials used in part manufacture satisfy current regulatory requirements applicable to the country of manufacture and sale. 

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Chemical methods to determine the crystalline content in silica have been reviewed (6). These are based on the solubility of amorphous silica in a variety of solvents, acids or bases, with respect to relatively inert crystalline silica, and include differences in reactivity in high temperature fusions with strong bases. These methods ate qualitative, however, and fail to satisfy regulatory requirements to determine crystallinity at 0.1% concentration in bulk materials. 

Any designated, trained (8-hour HAZWOPER supervisor course as a minimum), and experienced individual responsible for the safety of an employee (such as team leaders or crew leaders) may perform the function of an experienced person to provide the supervised field experience required by HAZWOPER [1]. Although having the appropriate certificates of completion would satisfy regulatory requirements, you should also consider time of service and experience. A fresh college graduate with training certificates and minimal field experience may be less desirable to perform supervised field experience than the safety professional with years of substantial field experience. 

End-user software acceptability testing is frequently performed to satisfy regulatory requirements however, it is also used to ensure system validity and identify deficiencies. 

In the pharmaceutical industry, most carcinogenicity studies have employed at least three dose levels in addition to the controls, but four levels have occasionally been used (PMA, 1988). The use of three or four dose levels satisfies regulatory requirements (Speid et al., 1990) as well as scientific and practical considerations. If a carcinogenic response is observed, information on the nature of the dose-... 

The U.S. Department of Energy (DOE) is researching technologies for the stabilization and immobilization of fly ash contaminated with radionuclides and metals that will reduce waste material volume and consistently satisfy regulatory requirements. The Mixed Waste Focus Area (MWFA), a DOE/EM-50 program, has stated the need for improved stabilization methods that would accept higher ash waste loadings. To address these issues, the MWFA has invested in a sintered ceramic stabilization technique developed by Clemson University. 

It is important to realize that as a prevention-based program, APRs are not the most effective mechanism. While an APR system satisfies regulatory requirements and provides a valuable reference tool, a comprehensive profile of product performance at the end of the year does not provide a useful prevention approach. A comprehensive and well-integrated recall prevention program, coupled with APR, provides a much more effective prevention-based mechanism and system. 

Other Agency guidances are available that consider specific scale-up and postapproval changes (SUPAC) for different types of drug products to help satisfy regulatory requirements in Part 320 and 314.70 (21 CFR 314.70). 

Classification and segregation of wastes by such criteria are essential for their safe handling and disposal. If the waste is not a common chemical with known characteristics, enough information about it must be supplied to satisfy regulatory requirements and be certain that it can be handled and disposed of safely. For many wastes, only the principal components must be specified. However, if the waste contains a carcinogen or toxic metal, this information should be supplied. The information needed to characterize a waste also depends on the method of ultimate disposal. 

This is cracial in satisfying regulatory requirements during product development. It should be noted, however, moderate toxicity and inflammatory reactions caused by polymers might be beneficial in ehciting immune responses. 

Regulatory compliance remedy satisfies regulatory requirements. 

Ensuring that reports satisfy regulatory requirements. 

Today, substantial cross-cutting between the medical and physical, chemical, and biological defense research communities already exists. For example, genetics research has long been incorporated into detection schemes in industrial pharmaceutical and medical device development. In some applied research and advanced development, however, islands of specialization remain isolated, for example, animal testing to satisfy regulatory requirements. 

Formal safety education for advanced students and laboratory workers should be made as relevant to their work activities as possible. Training that is conducted simply to satisfy regulatory requirements tends to subordinate the relevant safety issues to details associated with compliance. Such bureaucratic safety management has actually worked against fostering positive safety attitudes in many well-experienced laboratory workers and has undermined the credibility of warnings about bona fide hazards by emphasizing pro forma violation of rules. 

CHEMTREC also assists shippers of hazardous materials to satisfy regulatory requirements related to shipping chemicals and assists in chemical incidents and medical emergencies not related to transportation. Anyone with a chemical emergency may call, free of charge, to receive appropriate emergency response advice. 

The safety-by-design features of the reactor, with their vastly enhanced defence in depth provide an effective means of satisfying regulatory requirements for design basis events. The main effects of this approach on IRIS safety were listed in Tables 3 and 4 and are discussed here in some detail. All the events that are typically studied as part of Section 15 of the Safety Analysis Report according to the NRC Standard Review Plan (SRP) [19], and for which IRIS will present significant differences from current active and passive PWRs, are briefly discussed here. 

Water treatment plants use chemicals to remove contaminants, improve taste and appearance, and satisfy regulatory requirements. Accurate delivery of these chemicals to the point of application is critical to maintain and assess plant performance, to control the cost of treatment, and to predict the need for more supplies. 

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