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It is only possible to obtain analytical results that are suitable for their intended purpose if the equipment used is capable of producing measurements of the required quality. To ensure that this requirement is met, analysts sho...
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It is only possible to obtain analytical results that are suitable for their intended purpose if the equipment used is capable of producing measurements of the required quality. To ensure that this requirement is met, analysts should define the performance criteria required from the instruments, ensure that only suitable instruments are selected for analytical measurements, and confirm that these instruments continue to meet these criteria for their entire operational life. This process should be conducted on a formal, documented basis, known as equipment qualification. In addition to describing the key elements of equipment qualification for all analytical instruments, this paper gives specific guidance on its application to conductivity systems that has never previously appeared in the literature. The benefits of performing equipment qualification are highlighted and guidance is given on the selection of control standards and why the equipment vendor performing stages of equipment qualification can be of benefit to the user. The relationship between equipment qualification and method validation is discussed, including how these activities play a major role in determining the quality control measures that should be applied to routine analysis.
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This paper describes the development and application of guidance on EQ (EQ) of high performance liquid chromatography instruments. EQ is a formal process that provides documented evidence that an instrument is fit for its intended...
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This paper describes the development and application of guidance on EQ (EQ) of high performance liquid chromatography instruments. EQ is a formal process that provides documented evidence that an instrument is fit for its intended purpose and kept in a state of maintenance and calibration consistent with its use. [References: 12]
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Good manufacturing practices include the concept of equipment qualification which aims to demonstrate in a documented way that equipment operates correctly for its intended use and that it is properly maintained and calibrated. Eq...
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Good manufacturing practices include the concept of equipment qualification which aims to demonstrate in a documented way that equipment operates correctly for its intended use and that it is properly maintained and calibrated. Equipment qualification is the base to generate quality data and is formed by four phases: DQ, IQ, OQ and PQ. This article presents how to carry out OQ for a liquid chromatograph. A proposed OQ for a liquid chromatograph is based on a variety of tests that evaluate equipment from a modular point of view. There have also been discussed and set appropriate acceptance criteria whose selection has been based on a search and examination of the criteria used by manufacturers and an exhaustive study of equipment historical results.
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Questo articolo fornisce informazioni sull'inizio e sullo sviluppo delle attivita di qualificazione, di certificazione volontaria e cogente di aziende, personale, processi e prodotti di IIS e di US CERT, in Italia e all'estero. In...
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Questo articolo fornisce informazioni sull'inizio e sullo sviluppo delle attivita di qualificazione, di certificazione volontaria e cogente di aziende, personale, processi e prodotti di IIS e di US CERT, in Italia e all'estero. In particolare, vengono anzitutto considerati due periodi successivi: il primo, dal 1955 al 1979, ha visto essenzialmente l'affermazione e la crescita dell'attivita di qualificazione e di certificazione del personale di saldatura e PND, nonche delle procedure di saldatura; il secondo periodo, dal 1980 a meta del 2014, e stato inizialmente caratterizzato dalla creazione della "Commissione di Certificazione dell'IIS" e quindi da un vigoroso sviluppo in termini di quantita e tipologia delle qualificazioni, certificazioni, approvazioni e omologazioni emesse, dovuto anche ai numerosi e prestigiosi riconoscimenti nazionali ed internazionali ottenuti. Significativa anche la riorganizzazione, a partire dal 2010, della struttura aziendale e la partizione che ha condotto alla nascita del Gruppo US, costituto dall'Istituto Italiano della Saldatura - ente morale, e da tre srl, US CERT, US PROGRESS e US SERVICE, create a partire dal 2011. A meta del 2014, in US CERT lavoravano piu di quaranta di dipendenti, tra cui otto ingegneri, due dei quali dirigenti, ed oltre venti diplomati tecnici, mentre l'intero Gruppo US aveva in forza circa di 225 dipendenti, (tra cui una sessantina di laureati tecnici e un centinaio di diplomati tecnici).
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Learning outcomes represent one of the essential building blocks for transparency within higher education systems and qualifications. All aspects of their application were examined in the context of Bologna developments. Learning ...
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Learning outcomes represent one of the essential building blocks for transparency within higher education systems and qualifications. All aspects of their application were examined in the context of Bologna developments. Learning outcomes have been defined as: statements of what a learner is expected to know, understand and/or be able to do at the end of a period oflearning. A key element in contemporary qualifications frameworks is the specification of learning outcomes. The range of outcomes can be categorised and specified in various ways. Traditionally higher education was relatively explicit about theknowledge (outcomes) to be achieved, or at least the knowledge covered by the curriculum. The qualification descriptor represents a description or measurable indicator of learning outcomes and achievements for which the student has been assessed and which the student should be able to demonstrate for the qualification that is awarded. he specifics in the design of descriptors for different levels of qualifications for higher education are explained in detail in this paper.
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Purpose - This paper aims to explore structural and systemic influences in the development of competence models and qualifications systems at sectoral and national levels across Europe, considering the influences of different soci...
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Purpose - This paper aims to explore structural and systemic influences in the development of competence models and qualifications systems at sectoral and national levels across Europe, considering the influences of different socio-economic models of skill formation on the processes of design and provision of qualifications. Design/methodology/approach - The paper is based on a meta analysis of three European projects that used literature review, documentary analysis and interviews with practitioners and policy makers. Findings - The main methodological and practical challenges posed by varieties of competence and qualifications to inter-country comparability of qualifications are shown to be related to different socio-economic models of skill formation. Research limitations/implications - The research is limited to 13 countries and four sectors but these were carefully selected to maximise coverage of European diversity with respect to competence models, training regimes and approaches to qualifications. There is clearly a need for further research involving more countries and sectors. Practical implications - The paper offers recommendations for improving the potential of the European Qualifications Framework to promote comparability of qualifications and hence mobility of labour. These recommendations will be of interest to policy makers and practitioners involved in using the EQF and similar instruments. Originality/value - This is the first systematic attempt to explore the methodological and practical difficulties of establishing comparability between qualifications.
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One of the stages of work on the Sectoral Qualifications Framework for Mining (SQFM) was to verify its initial design as a result of quantitative research using questionnaires and qualitative research through in-depth interviews (...
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One of the stages of work on the Sectoral Qualifications Framework for Mining (SQFM) was to verify its initial design as a result of quantitative research using questionnaires and qualitative research through in-depth interviews (IDI). Their main goal was to identify the opinions and attitudes of respondents related to the mining industry towards the implemented SQFM project. Both people working in mining plants and in other companies and units related to the mining sector were invited to take part in the project. The expected result of the conducted research was the collection of material allowing for the verification of the provisions in terms of the needs and expectations of employers as to the qualifications of the employed employees and the assessment of the legitimacy of the proposed solutions. In designing the research, the use of qualitative and quantitative methods was assumed. This made it possible to triangulate the data - looking at the studied research problems from different perspectives, which was to influence the obtaining of empirical material allowing for the analysis of the discussed problems taking into account various points of view. As a result, the image of the needs in the area of increasing competences and the main deficits in the mining sector has crystallized.
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The future will hold challenges for everyone working in the Galleries, Libraries, Archives and Museums (GLAM) sector. The application of technologies, many of which are yet to be discovered, will change work patterns and the type ...
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The future will hold challenges for everyone working in the Galleries, Libraries, Archives and Museums (GLAM) sector. The application of technologies, many of which are yet to be discovered, will change work patterns and the type of professional employees required. Organisations that support more than one activity in the sector will seek to combine them and have staff who are multi-skilled. This may result in a devaluation of professional qualifications in favour of generalist qualifications supplemented by professional development. Hiring staff with non-traditional qualifications has always occurred and will increase. In future, staff will move more easily across the sector without necessarily having formal qualifications related to their new duties. There will be greater emphasis on structured career-long professional development that is more multidisciplinary than may be currently offered. There is a need to beginning re-imagining what distinguishes a curator, librarian, archivist or other GLAM professional. Is it really necessary to have specialist qualifications to work effectively in the sector? If so, what are those qualifications and how are they best obtained?
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This qualification study deals with the Installation and Qualification of a New Tray Dryer. Granules in the pharmaceutical industry are dried using the different equipment like Fluid Bed Dryer, Belt Dryer, Tray Dryer, Vacuum Tray ...
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This qualification study deals with the Installation and Qualification of a New Tray Dryer. Granules in the pharmaceutical industry are dried using the different equipment like Fluid Bed Dryer, Belt Dryer, Tray Dryer, Vacuum Tray Dryer, Spray Dryer and Rotary Dryer. In this case, the study was conducted on the newly installed laboratory Tray Dryer. Various documentation requirements like User Requirement Specification, Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification and Performance Qualification were carried out for the equipment. Calibration of measuring devices, the prepared granules were dried using the tray drier and noted the time required to dry the granules. Equipment qualification of newly installed laboratory Tray Dryer was performed meeting all the qualification parameters.
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Our objectives are to describe the procedure for qualification advice and opinion from EU regulators on the use of novel methodologies in drug development, the key stakeholders involved and the evidence requirements for qualification opinion.
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