Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica

Detalhes bibliográficos
Autor(a) principal: Barakat, Májida Farid
Data de Publicação: 2017
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Biblioteca Digital de Teses e Dissertações da Uninove
Texto Completo: http://bibliotecatede.uninove.br/handle/tede/1703
Resumo: This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed.
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spelling Berssaneti, Fernando TobalBerssaneti, Fernando TobalSantana, José Carlos CurveloFleury, André Lemehttp://lattes.cnpq.br/8868794635240284Barakat, Májida Farid2017-08-04T21:37:42Z2017-03-07Barakat, Májida Farid. Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica. 2017. 96 f. Dissertação( Programa de Mestrado em Engenharia de Produção) - Universidade Nove de Julho, São Paulo.http://bibliotecatede.uninove.br/handle/tede/1703This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed.Este trabalho trata de um estudo de caso quantitativo e qualitativo dirigido para a análise crítica da contribuição do gerenciamento de riscos em projetos de transferência de tecnologia intracompanhia farmacêutica. Foi considerado um projeto de alteração do local de fabricação, embalagem e controle de qualidade de um medicamento sólido oral realizado em nível regional, entre plantas localizadas em diferentes municípios do estado de São Paulo para atender a estratégia comercial de uma companhia multinacional farmacêutica. Este projeto teve início em 2013, incluindo planejamento, organização e execução com previsão de conclusão em 2015. Foi realizada análise qualitativa dos riscos relacionados aos atendimentos de escopo e requisitos da qualidade do projeto e também análise quantitativa dos riscos relacionados ao cumprimento do prazo do projeto. Para confirmar ou refutar as seis proposições de pesquisa apresentadas, foram realizadas entrevistas semiestruturadas e observação direta na unidade de análise, revisão bibliográfica e análise de dados. Os resultados mostram que após análise qualitativa dos riscos do projeto relacionados aos atendimentos de escopo e requisitos da qualidade utilizando a ferramenta Análise de Modo de Falha e seus Efeitos - FMEA, foram identificados 39 modos de falha, com valores de Número de Prioridade de Risco - NPR variando de 70 a 288, sendo os de maior severidade e, portanto, prioridade os referentes aos requisitos da qualidade quanto a regulamentação sanitária. Indicam, também, que a partir da Simulação de Monte Carlo o prazo máximo esperado para o projeto é de 1841 dias e o mínimo de 1473 dias. A conclusão da pesquisa mostra que as proposições não se confirmam de forma plena. Foi proposto um plano de ação objetivando a mitigação dos riscos analisados.Submitted by Nadir Basilio (nadirsb@uninove.br) on 2017-08-04T21:37:42Z No. of bitstreams: 1 Majida Farid Barakat.pdf: 1578082 bytes, checksum: 0ce4d1fce799ec5caafefd77e0d78c25 (MD5)Made available in DSpace on 2017-08-04T21:37:42Z (GMT). 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dc.title.por.fl_str_mv Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
dc.title.alternative.eng.fl_str_mv Risk management in an intracompany pharmaceutical technology transfer project
title Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
spellingShingle Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
Barakat, Májida Farid
gerenciamento de projetos
gerenciamento de risco
projeto de transferência de tecnologia
project management
risk management
technology transfer project
ENGENHARIAS::ENGENHARIA DE PRODUCAO
title_short Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
title_full Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
title_fullStr Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
title_full_unstemmed Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
title_sort Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
author Barakat, Májida Farid
author_facet Barakat, Májida Farid
author_role author
dc.contributor.advisor1.fl_str_mv Berssaneti, Fernando Tobal
dc.contributor.referee1.fl_str_mv Berssaneti, Fernando Tobal
dc.contributor.referee2.fl_str_mv Santana, José Carlos Curvelo
dc.contributor.referee3.fl_str_mv Fleury, André Leme
dc.contributor.authorLattes.fl_str_mv http://lattes.cnpq.br/8868794635240284
dc.contributor.author.fl_str_mv Barakat, Májida Farid
contributor_str_mv Berssaneti, Fernando Tobal
Berssaneti, Fernando Tobal
Santana, José Carlos Curvelo
Fleury, André Leme
dc.subject.por.fl_str_mv gerenciamento de projetos
gerenciamento de risco
projeto de transferência de tecnologia
topic gerenciamento de projetos
gerenciamento de risco
projeto de transferência de tecnologia
project management
risk management
technology transfer project
ENGENHARIAS::ENGENHARIA DE PRODUCAO
dc.subject.eng.fl_str_mv project management
risk management
technology transfer project
dc.subject.cnpq.fl_str_mv ENGENHARIAS::ENGENHARIA DE PRODUCAO
description This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed.
publishDate 2017
dc.date.accessioned.fl_str_mv 2017-08-04T21:37:42Z
dc.date.issued.fl_str_mv 2017-03-07
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
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dc.identifier.citation.fl_str_mv Barakat, Májida Farid. Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica. 2017. 96 f. Dissertação( Programa de Mestrado em Engenharia de Produção) - Universidade Nove de Julho, São Paulo.
dc.identifier.uri.fl_str_mv http://bibliotecatede.uninove.br/handle/tede/1703
identifier_str_mv Barakat, Májida Farid. Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica. 2017. 96 f. Dissertação( Programa de Mestrado em Engenharia de Produção) - Universidade Nove de Julho, São Paulo.
url http://bibliotecatede.uninove.br/handle/tede/1703
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dc.publisher.department.fl_str_mv Engenharia
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