93 resultados para CERTIFICATION


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Pós-graduação em Agronomia (Energia na Agricultura) - FCA

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Pós-graduação em Agronomia (Energia na Agricultura) - FCA

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Pós-graduação em Agronomia (Energia na Agricultura) - FCA

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Pós-graduação em Educação - FFC

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Pós-graduação em Educação - FFC

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Pós-graduação em Serviço Social - FCHS

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

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The publication of the Law 10,267 of 08/28/2001 changed the paradigm of rural registration in Brazil, because this law known as the Law of Georeferencing has created the National Registration of Rural Property, that unifies in a common basis different registrations present in several government agencies, such as the National Institute for Colonization and Agrarian Reform (INCRA), the Secretariat of Federal Revenue, the Brazilian Institute of Environment and Natural Resources, and the National Indian Foundation. Also, this new registration system has a graphical component which has not existed until such date, where the boundaries of rural property are georeferenced to the Brazilian Geodetic System. This new paradigm has resulted in a standardization of the survey and its representation of rural properties according to the Technical Standard for Georeferencing of Rural Properties, published by INCRA in compliance with the new legislation. Due to the georeferencing, the creation of a public GIS of free access on the Internet was possible. Among the difficulties found it may be observed the great Brazilian territory, the need for specialized professionals, and especially the certification process that INCRA has to perform for each georeferenced property. It is hoped that this last difficulty is solved with the implementation of the Land Management System that will allow automated and online certification, making the process more transparent, agile and fast.

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This work aims to identify the main motivations and difficulties faced by Brazilian companies to obtain ISO 9001 certification. The key quality management practices that provide support to this certification and the relationship with other types of systems, such as ISO 14001 (Environmental Management) and OHSAS 18001 (Occupational Health and Safety Management System), were also investigated. A survey research was conducted with 191 companies. The main motivations for implementing ISO 9001 are the following: internal organization improvement, production efficiency increase, and brand reliability improvement. Employee resistance was the greatest challenge found during the implementation process. On the other hand, the main benefits identified were: quality processes improvement and increased employee awareness of quality. The results reveal that the most common quality programs and tools used are: 5S, brainstorming, and Ishikawa diagram, while the least common are SERVQUAL and QFD.

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)