831 resultados para Medicinal Product Liability
Resumo:
Product assurance is an essential part of product development process if developers want to ensure that final product is safe and reliable. Product assurance can be supported withrisk management and with different failure analysis methods. Product assurance is emphasized in system development process of mission critical systems. The product assurance process in systems of this kind requires extra attention. Inthis thesis, mission critical systems are space systems and the product assurance processof these systems is presented with help of space standards. The product assurance process can be supported with agile development because agile emphasizes transparency of the process and fast response to changes. Even if the development process of space systems is highly standardized and reminds waterfall model, it is still possible to adapt agile development in space systems development. This thesisaims to support the product assurance process of space systems with agile developmentso that the final product would be as safe and reliable as possible. The main purpose of this thesis is to examine how well product assurance is performed in Finnish space organizations and how product assurance tasks and activities can besupported with agile development. The research part of this thesis is performed in survey form.
Resumo:
Product assurance is an essential part of product development process if developers want to ensure that final product is safe and reliable. Product assurance can be supported with risk management and with different failure analysis methods. Product assurance is emphasized in system development process of mission critical systems. The product assurance process in systems of this kind requires extra attention. In this thesis, mission critical systems are space systems and the product assurance process of these systems is presented with help of space standards. The product assurance process can be supported with agile development because agile emphasizes transparency of the process and fast response to changes. Even if the development process of space systems is highly standardized and reminds waterfall model, it is still possible to adapt agile development in space systems development. This thesis aims to support the product assurance process of space systems with agile development so that the final product would be as safe and reliable as possible. The main purpose of this thesis is to examine how well product assurance is performed in Finnish space organizations and how product assurance tasks and activities can be supported with agile development. The research part of this thesis is performed in survey form.
Resumo:
The purpose of this master’s thesis was to study the opportunity to apply Lean practices to product management function which happens in an office environment. Since product management plays an important role in the company’s success story, it’s important to have it functioning as effectively as possible. The goal was to find those Lean tools and methods that fit the best to the needs of product management. The research was conducted as a qualitative action research which comprises a comprehensive literature review and a single case study. Theoretical information about Lean Thinking and product management was collected from articles, literature and Internet sources. Moreover, empirical data was collected by conducting interviews in the Case Company’s product management department in order to gain an in-depth understanding of product management’s problematics. The results indicate that most of the product management challenges could be overcome by applying Lean practises. Based on the usability rate, which has been discussed in the empirical part of this study, the most suitable Lean practises for product management function are: value stream mapping, Kanban and KPIs.
Resumo:
The thesis presents the study relative to the collaboration between suppliers and buyers in packaging industry with the impact of product features. The main purpose of this study is to examine the importance of product characteristics on collaboration to develop better packaging and to figure out how buyer-supplier collaboration in the supply chain perspectives is conducted and managed in packaging industry. The theoretical part reviewed some basic frameworks of collaboration including the scopes and levels of collaboration, risks as well as powers of collaboration, relationship and some key factors for successful collaboration. Followed by the overviews of packaging industry with the main issues related to product characteristics in packaging. By using the qualitative method, secondary data consisting of articles, reports, websites and primary data through interviewing some well-known packaging companies and case companies are collected in the thesis. The empirical result emphasized the importance of product features’ analysis in packaging industry since it plays a central role in the materials, design process, production and innovation with the role of collaboration. Collaboration in packaging is vital for packaging companies to survive and grow in the competitive environment. Finally, some key factors for effective collaboration were summarized based on the perspectives of packaging companies. It is highly recommend building a long-run collaboration with their customers due to undeniable benefits With increasingly importance of collaboration in packaging industry, further studies may be conducted.
Resumo:
Product Data Management (PDM) systems have been utilized within companies since the 1980s. Mainly the PDM systems have been used by large companies. This thesis presents the premise that small and medium-sized companies can also benefit from utilizing the Product Data Management systems. Furthermore, the starting point for the thesis is that the existing PDM systems are either too expensive or do not properly respond to the requirements SMEs have. The aim of this study is to investigate what kinds of requirements and special features SMEs, operating in Finnish manufacturing industry, have towards Product Data Management. Additionally, the target is to create a conceptual model that could fulfill the specified requirements. The research has been carried out as a qualitative case study, in which the research data was collected from ten Finnish companies operating in manufacturing industry. The research data is formed by interviewing key personnel from the case companies. After this, the data formed from the interviews has been processed to comprise a generic set of information system requirements and the information system concept supporting it. The commercialization of the concept is studied in the thesis from the perspective of system development. The aim was to create a conceptual model, which would be economically feasible for both, a company utilizing the system and for a company developing it. For this reason, the thesis has sought ways to scale the system development effort for multiple simultaneous cases. The main methods found were to utilize platform-based thinking and a way to generalize the system requirements, or in other words abstracting the requirements of an information system. The results of the research highlight the special features Finnish manufacturing SMEs have towards PDM. The most significant of the special features is the usage of project model to manage the order-to-delivery –process. This differs significantly from the traditional concepts of Product Data Management presented in the literature. Furthermore, as a research result, this thesis presents a conceptual model of a PDM system, which would be viable for the case companies interviewed during the research. As a by-product, this research presents a synthesized model, found from the literature, to abstract information system requirements. In addition to this, the strategic importance and categorization of information systems within companies has been discussed from the perspective of information system customizations.
Resumo:
This thesis focuses on consolidation the recommendations on the integration of consumer in new product development (NPD) given in the academic literature, and on the example of the three NPD projects in the case company. The empirical findings advocate that the case company fulfills the principles of consumer-led NPD, and it is only one-step away of the full consumer empowerment strategy. Therefore, its NPD can be seen as an example of consumer-led NPD implementation. The findings also suggest that the product can be developed in consumer-led way regardless of the source of an idea (product- or need-driven), the target audience and resources assigned, in case when consumer mindset is integrated on all levels of organisation: strategic, cultural, operational and process. It is possible with top-management commitment, internal consumer research group, and the sophisticated consumer research methods. The specific managerial recommendations are given on developing consumer-led culture, strategy, NPD process and the appropriate consumer research methods and techniques.
Resumo:
The purpose of conducting this thesis is to gather around information about additive manufacturing and to design a product to be additively manufactured. The specific manufacturing method dealt with in this thesis, is powder bed fusion of metals. Therefore when mentioning additive manufacturing in this thesis, it is referred to powder bed fusion of metals. The literature review focuses on the principle of powder bed fusion, the general process chain in additive manufacturing, design rules for additive manufacturing. Examples of success stories in additive manufacturing and reasons for selecting parts to be manufactured with additive manufacturing are also explained in literature review. This knowledge is demanded to understand the experimental part of the thesis. The experimental part of the thesis is divided into two parts. Part A concentrates on finding proper geometry for building self-supporting pipes and proper parameters for support structures of them. Part B of the experimental part concentrates on a case study of designing a product for additive manufacturing. As a result of experimental part A, the design process of self-supporting pipes, results of visual analysis and results of 3D scanning are presented. As a result of experimental part B the design process of the product is presented and compared to the original model.
Resumo:
Under EU competition law, parent companies may be held jointly and severally liable for the competition law infringements committed by their subsidiaries. The possibility of holding parent companies liable demonstrates a significant exception from the idea of separate legal entities. However, it is not the only deviation developed under EU competition law. In cases, where the legal entity responsible for the anti-competitive conduct has changed its form, liability can be attributed to the new operator, in particular, to its successor. The principles of legal certainty and legitimate expectations are issues that surround the doctrines of parental and successor liability. The aim of this thesis is to present a comprehensive comparative analysis of the parental and successor liability doctrines and to clarify the conditions under which it is possible to attribute liability for the infringements of EU competition law. The main purpose is therefore to demonstrate the problems related to the allocation of liability and to discuss whether these liability principles, established to assure the effective enforcement of the EU competition rules, are good solutions. The research methods used in this thesis are the legal dogmatic approach and the comparative law approach. The former enables the possibility of using the case law and legislation as a framework in which the difficulties concerning the application of parental and successor liability can be discussed while the latter ensures the comparison of the characteristics and judgments. The doctrines of parental and successor liability are both well established, but the application practice has caused several difficulties. These problems derive from, inter alia, the broadness and disjointed developed of the doctrines. There has been much recent case law dealing with these issues and having the potential to open up a considerable risk and to allocate strict liability for parent and successor companies.
Resumo:
Celebrity endorsement has increased in popularity over the past decades and companies are willing to spend increasingly excessive amounts of money into it. Even though multiple studies support celebrity endorsement, further research on its impact on advertising effectiveness is called for. Fur-ther, the role of consumers’ product class involvement in advertising needs to be further studied. The purpose of this study is to explore if consumers’ product class involvement and exposure to celebrity endorsers affect consumers brand recall. Supported by earlier studies, brand recall was used as a measure for advertising effectiveness in this study. In general, a psychological approach was chosen for building the theoretical framework. Concept of classical conditioning was presented in order to understand why people act how they do. Balanced theory and meaning transfer model were presented in order to study how celebrities can be used effectively in advertising context. Further, the importance of product class involvement in advertising effectiveness was evaluated. Hypotheses were formulated based on a literature review of the existing research. Because of the versatility of the research design, a mixed methods approach for this study was adopted. Empirical part of the study was conducted in three stages. First, a pre-test was conducted in order to choose suitable product endorsers for the advertisement stimuli used in the experiment. Second, an eye-tracking experiment with 30 test subjects was conducted in order to study how people view advertisements and whether the familiarity of the product endorser and consumers’ product class involvement affects brand recall. For the experiment, a fictional brand was created in order to avoid bias on brand recall. Third, qualitative interviews for 15 test subjects were conducted in the post-experiment stage in order to gain deeper understating of the phenomenon and to make sense of the findings from the experiment. Findings from this study support celebrity endorsement by suggesting that a famous spokesperson does not steal attention from brand information more than a non-celebrity product endorser. As a result, the use of a celebrity endorser did not decrease brand recall. Results support earlier research as consumer’ higher product class involvement resulted in a better brand recall. Findings from the interviews suggest that consumers have positive perceptions of celebrity endorsement in general. However, the celebrity–brand congruence is a crucial factor when creating attitudes towards the advertisement. Future research ideas were presented based on the limitations and results of this study
Resumo:
There is an increasing amount of product-harm crisis in the past few years; and the impact of a product-harm crisis becomes more and more influential due to the high increasing speed of globalization. And it is believed that the negative damages to a firm leading to a loss of the intangible assets is bigger than other costs such as the cost of the product recall. Brand equity is a very important and valuable intangible asset for a firm; and it is particularly vulnerable during the crisis. And CSP (CSP) is a hot concept associated with product-harm crisis and brand equity. The aim of this study is to understand how product-harm crisis influences by simultaneously involving CSP as a moderator in a consumer-based level. An experimental study was conducted through an online questionnaire among 198 students in Finland. The questionnaire mainly assessed the consumers’ attitudes towards CSP and brand before/after a fictional product-harm crisis. The results shows that the brand equity was negatively related to the product-harm crisis. And the extent level of crisis’s severity was positively related to the loss of the brand equity; whereas, acknowledged blame was more useful to compensate the loss of brand equity in the low-severity crisis. CSP acted as a moderator role which could compensate the loss of brand equity caused by the product-harm crisis. Managerial implications are also offered for crisis managers, brand managers, and CSR managers.
Resumo:
This study discusses the importance of learning through the process of exporting, and more specifically how such a process can enhance the product innovativeness of a company. The purpose of this study is to investigate the appropriate sources of learning and to suggest an interactive framework for how new knowledge from exporting markets can materialize itself into product innovation. The theoretical background of the study was constructed from academic literature, which is related to concepts of learning by exporting, along with sources for learning in the market and new product development. The empirical research in the form of a qualitative case study was based on four semi-structured interviews and secondary data from the case company official site. The interview data was collected between March and April 2015 from case company employees who directly work in the department of exporting and product development. The method of thematic analysis was used to categorize and interpret the collected data. What was conclusively discovered, was that the knowledge from an exporting market can be an incentive for product innovation, especially an incremental one. Foreign customers and competitors as important sources for new knowledge contribute to the innovative process. Foreign market competitors’ influence on product improvements was high only when the competitor was a market leader or held a colossal market share, while the customers’ influence is always high. Therefore, involving a foreign customer in the development of a new product is vital to a company that is interested in benefiting from what is learned through exporting. The interactive framework, which is based on the theoretical background and findings of the study, suggests that exporting companies can raise their product innovativeness by utilizing newly gained knowledge from exporting markets. Except for input, in the form of sources of learning, and product innovation as an output, the framework contains a process of knowledge transfer, the absorptive capacity of a firm and a new product development process. In addition, the framework and the findings enhance the understanding of the disputed relationship between an exporting experience and product innovation. However, future research is needed in order to fully understand all the elements of the framework, such as the absorptive capacity of a firm as well as more case companies to be processed in order to increase the generalization of the framework
Resumo:
The purpose of this research is to examine the different opportunities that companies operating on international level has for conducting a product recall. The main subject of the research is strategic decision-making of recall and product recall process. The theoretical framework, core of the research, is based on research questions. The research is performed as qualitative case study and the material has been collected by combining results of previous studies and by observing the case company. Different opportunities for conducting a recall are examined in the empirical part of this study. As a result, different product recall models have been created, which all require deep cooperation between different entities of the supply chain.
Resumo:
The Chinese welding industry is growing every year due to rapid development of the Chinese economy. Increasingly, companies around the world are looking to use Chinese enterprises as their cooperation partners. However, the Chinese welding industry also has its weaknesses, such as relatively low quality and weak management. A modern, advanced welding management system appropriate for local socio-economic conditions is required to enable Chinese enterprises to enhance further their business development. The thesis researches the design and implementation of a new welding quality management system for China. This new system is called ‗welding production quality control management model in China‘ (WQMC). Constructed on the basis of analysis of a survey and in-company interviews, the welding management system comprises the following different elements and perspectives: a ‗Localized congenital existing problem resolution strategies‘ (LCEPRS) database, a ‗human factor designed training system‘ (HFDT) training strategy, the theory of modular design, ISO 3834 requirements, total welding management (TWM), and lean manufacturing (LEAN) theory. The methods used in the research are literature review, questionnaires, interviews, and the author‘s model design experiences and observations, i.e. the approach is primarily qualitative and phenomenological. The thesis describes the design and implementation of a HFDT strategy in Chinese welding companies. Such training is an effective way to increase employees‘ awareness of quality and issues associated with quality assurance. The study identified widely existing problems in the Chinese welding industry and constructed a LCEPRS database that can be used in efforts to mitigate and avoid common problems. The work uses the theory of modular design, TWM and LEAN as tools for the implementation of the WQMC system.
Resumo:
Catharanthus roseus is the sole biological source of the medicinal compounds vinblastine and vincristine. These chemotherapeutic compounds are produced in the aerial organs of the plant, however they accumulate in small amounts constituting only about 0.0002% of the fresh weight of the leaf. Their limited biological supply and high economical value makes its biosynthesis important to study. Vinblastine and vincristine are dimeric monoterpene indole alkaloids, which consists of two monomers vindoline and catharanthine. The monoterpene indole alkaloids (MIA's) contain a monoterpene moiety which is derived from the iridoid secologanin and an indole moiety tryptamine derived from the amino acid tryptophan. The biosynthesis of the monoterpene indole alkaloids has been localized to at least three cell types namely, the epidermis, the laticifer and the internal phloem assisted parenchyma. Carborundum abrasion (CA) technique was developed to selectively harvest epidermis enriched plant material. This technique can be used to harvest metabolites, protein or RNA. Sequencing of an expressed sequence tagged (EST) library from epidermis enriched mRNA demonstrated that this cell type is active in synthesizing a variety of secondary metabolites namely, flavonoids, lipids, triterpenes and monoterpene indole alkaloids. Virtually all of the known genes involved in monterpene indole alkaloid biosynthesis were sequenced from this library.This EST library is a source for many candidate genes involved in MIA biosynthesis. A contig derived from 12 EST's had high similarity (E'^') to a salicylic acid methyltransferase. Cloning and functional characterization of this gene revealed that it was the carboxyl methyltransferase imethyltransferase (LAMT). In planta characterization of LAMT revealed that it has a 10- fold enrichment in the leaf epidermis as compared to the whole leaf specific activity. Characterization of the recombinant enzyme revealed that vLAMT has a narrow substate specificity as it only accepts loganic acid (100%) and secologanic acid (10%) as substrates. rLAMT has a high Km value for its substrate loganic acid (14.76 mM) and shows strong product inhibition for loganin (Kj 215 |iM). The strong product inhibition and low affinity for its substrate may suggest why the iridoid moiety is the limiting factor in monoterpene indole alkaloid biosynthesis. Metabolite profiling of C. roseus organs shows that secologanin accumulates within these organs and constitutues 0.07- 0.45% of the fresh weight; however loganin does not accumulate within these organs suggesting that the product inhibition of loganin with LAMT is not physiologically relevant. The limiting factor to iridoid and MIA biosynthesis seems to be related to the spatial separation of secologanin and the MIA pathway, although secologanin is synthesized in the epidermis, only 2-5% of the total secologanin is found in the epidermis while the remaining secologanin is found within the leaf body inaccessable to alkaloid biosynthesis. These studies emphasize the biochemical specialization of the epidermis for the production of secondary metabolites. The epidermal cells synthesize metabolites that are sequestered within the plant and metabolites that are secreted to the leaf surface. The secreted metabolites comprise the epidermome, a layer separating the plant from its environment.
Resumo:
Rates and products of the oxidation of diphenyl sulfide, phenyl methyl sulfide, p-chlorophenyl methyl sulfide and diphenyl sulfoxide have been determined. Oxidants included t-Bu02H alone, t-Bu02H plus molybdenum or vanadium catalysts and the molybdenum peroxo complex Mo0(02)2*HMPT. Reactions were chiefly carried out in ethanol at temperatures ranging from 20° to 65°C. Oxidation of diphenyl sulfide by t-Bu02H in absolute ethanol at 65°C followed second-order kinetics with k2 = 5.61 x 10 G M~1s"1, and yielded only diphenyl sulfoxide. The Mo(C0)g-catalyzed reaction gave both the sulfoxide and the sulfone with consecutive third-order kinetics. Rate = k3[Mo][t-Bu02H][Ph2S] + k^[Mo][t-Bu02H][Ph2S0], where log k3 = 12.62 - 18500/RT, and log k^ = 10.73 - 17400/RT. In the absence of diphenyl sulfide, diphenyl sulfoxide did not react with t-Bu02H plus molybdenum catalysts, but was oxidized by t-Bu02H-V0(acac)2. The uncatalyzed oxidation of phenyl methyl sulfide by t-Bu02H in absolute ethanol at 65°C gave a second-order rate constant, k = 3.48 x 10~"5 M^s""1. With added Mo(C0)g, the product was mainly phenyl methyl sulfoxide; Rate = k3[Mo][t-Bu02H][PhSCH3] where log k3 = 22.0 - 44500/RT. Both diphenyl sulfide and diphenyl sulfoxide react readily with the molybdenum peroxy complex, Mo0(02)2'HMPT in absolute ethanol at 35°C, yielding diphenyl sulfone. The observed features are mainly in agreement with the literature on metal ion-catalyzed oxidations of organic compounds by hydroperoxides. These indicate the formation of an active catalyst and the complexation of t-Bu02H with the catalyst. However, the relatively large difference between the activation energies for diphenyl sulfide and phenyl methyl sulfide, and the non-reactivity of diphenyl sulfoxide suggest the involvement of sulfide in the production of an active species.