نتایج جستجو برای: international harmonization
تعداد نتایج: 311925 فیلتر نتایج به سال:
Results from clinical laboratory measurement procedures must be equivalent to enable effective use of clinical guidelines for disease diagnosis and patient management. Analytical results that are harmonized and independent of the measurement system, time, and location of testing is essential for providing adequate patient care. The key to generating harmonized results is establishing traceabili...
This Note analyzes current international regulations for the deliberate release of genetically modified organisms into the environment. Part I describes the benefits and risks associated with the introduction of GMOs into the environment and presents an overview of deliberate release regulations in various countries to show the range of standards in individual nations. Part II analyzes internat...
This paper proposes a harmonization between a product quality model and a software process model used in the industry, CERTICS (a national Brazilian model) and CMMI-DEV (an international model). The focus of this harmonization is on the Competence Area of Continuous Improvement of CERTICS, which addresses the key question of whether the software is the result of Continuous Improvement actions o...
Significant opportunities and challenges are presented when transitioning from managing laboratory automation development of pharmaceutical products at a single site to collaborative management with multiple domestic and international sites. Prior to integrating Glaxo and Burroughs Wellcome about two years ago, each company had expertise in laboratory automation, but neither had a strategy for ...
In 1999 the International Federation for Information Processing (IFIP) released a document entitled “Harmonization of Professional Standards” [1] which had been developed by a small working group within the Technical Committee for Education (IFIP TC3). The purpose of the document was to set out what could become an international standard for professional practice in Information Technology. The ...
The International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice is a global project that is publishing criteria for both proliferative and nonproliferative changes in laboratory animals. This paper presents a set of general suggestions for terminology across systems. These suggestions include the use of diagnostic versus descriptive terms, modifiers, combina...
SUMMARY: PHMSA is amending the Hazardous Materials Regulations to maintain alignment with international standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport limited quantities, and vessel stowage requirements. These revisions are necessary to harmonize the Hazardous ...
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