Qualification Strategy Research Articles

Continuing health education for qualification of professional practice in Psychosocial Care Centers.

to describe and analyze a strategy of continuing health education to manage the quality of professionals' work in Psychosocial Care Centers. this is a research-intervention carried out in Psychosocial Care Centers in the state of Goiás, Brazil, with the participation of 58 professionals. Data were collected in 2016 through seminars and workshops. Thematic content analysis was carried out. professionals associated the Singular Therapeutic Project to the record of performed procedures and described the need to develop skills for correct completion and interpretation of procedures, use of a record software and computerization of processes. The qualification strategy used was considered to be effective in making improvements to the work carried out feasible. the study presents a qualification strategy for community mental health service teams to guide the care model for territorial care centered on users.

Data analysis to assess part quality in DED-LB/M based on in-situ process monitoring

In the field of Laser beam Direct Energy Deposition (DED-LB/M) for metal additive manufacturing, the implementation of qualification strategies parts from monitoring data and reduced order models is presently at low level of maturity. In this work, a methodology and a suite of novel data analysis tools targeting the joint analysis of multimodal data: process parameters, coaxial thermal imaging and part quality by Computer Tomography scans is presented. To demonstrate the proposed approach, a set of stainless-steel coupons were built with varying process parameters (power, process speed) and path planning strategies. Exploratory data analysis and feature engineering was performed on the dataset: process indicators, thermal and geometrical monitoring features are correlated to spatially resolved defects (mainly cracks) as well as the overall part quality obtained from the inspection phase paving the way for further implementation of in-situ process monitoring as a reliable tool for process optimization and qualification.

The experience of the Professional Qualification Course in Environmental Health Surveillance: a polytechnical education proposal for SUS in Brazil

One of the main difficulties and challenges for the consolidation and operationalization of the environmental health policy in the Brazil’s Unified Public Health System (SUS) is the establishment of both processes and pedagogical strategies for training and professional education at high school and undergraduate levels that are capable to answer the demands and needs of this area. This study aimed to discuss the importance of the formative processes of the Professional Qualification Course in Environmental Health Surveillance and its relevance as a qualification strategy for the SUS. The methodology consisted in the qualitative analysis on the teaching-learning dimensions involved in the establishment of this formative strategy. The observed results indicate to the force of technical qualification in the development of skills and competencies with a purpose to criticality in working with the SUS. It was concluded that this course brought significant learning to the strategy of training workers attentive to the determinants and conditioning factors in health.

Ethische Implikationen in der Entwicklung eines funktionellen Trainings in einer Mixed- und Augmented Reality Umgebungen zur Behandlung von Hypertonie im Alter: Eine qualitative Inhaltsanalyse

BackgroundE-Health is of increasing importance in ensuring demand-oriented health care. In addition to technical feasibility, issues concerning the normative requirements for their use are growing. This paper discusses the ethical, legal and social implications of the use of mixed reality (MR) and augmented reality (AR) technologies in the therapy of elderly people with hypertension. It is based on the results of a study conducted as a part of the BMBF project BewARe. MethodsIn the context of the above-mentioned background, an expert workshop was held with various stakeholders in an early phase of the BewARe project in accordance with the MEESTAR model, in which ethical, social and legal requirements for the development and use of AR/MR technologies were anticipated. The results of the workshop were subsequently evaluated using content analysis. ResultsContent analysis identified eight main challenges for the development and use of AR/MR technologies in the therapy of elderly people with hypertension: ethical challenges for the decision-making and action capacity of older users (1), stereotyping (2), user-oriented development and implementation (3), data protection (4), support (5), health risks (6), social participation (7), and the need for an integrative approach (8). DiscussionIn line with other studies, it can be shown that orientation towards medical guidelines and behavioral principles is essential to promote acceptance and adherence among end users and to minimize potential health risks. In addition, end users should be more strongly involved in the development process to overcome existing user stereotypes and establish qualification strategies for health-promoting use. Finally, legal and health economic framework conditions must be created to ensure data security and sustainable application concepts. ConclusionFor a successful diffusion of AR/MR applications in health care, a holistic implementation concept is required which must involve various groups of social actors. In this context, the article discusses eight main challenges that can be understood as current challenges in this process.

Efficient Qualification Strategy of New Steel Alloys for Laser Powder Bed Fusion

The requirements regarding the materials in use are steadily increasing in the AM market. As part of a GER-CAN research project (HiPTSLAM), the development of high-performance tool steels for AM is a promising topic regarding the acceptance of LPBF technology for functionally optimized die, forming and cutting tools. Therefore, a holistic development process to efficiently qualify new materials is introduced and its advantages are shown based on a case study with a maraging tool steel. The chemical composition of the steel was particularly developed for the use in the LPBF process to achieve beneficial performance properties. In the case study, effects of the LPBF parameters are evaluated on the material properties. Based on initial microstructure analysis, a promising set of parameters is used to build samples for heat treatment studies and mechanical characterization. By means of further investigations on the process interfaces, it will be possible to optimize the interaction of the whole LPBF process chain to increase the number of qualified materials with better performance properties.

A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products.

During storage and distribution of a packaged drug product, chemical substances present in or on the packaging may leach into the drug product, potentially adversely affecting the drug product's key quality attributes, including safety. Thus, the packaging is profiled for extractables as potential leachables and/or the drug product is profiled for leachables over shelf life via the process of chemical characterization. In so doing, the packaging and the packaged drug product are qualified as being suited for their intended use. It is reasonable to propose that the extent of chemical characterization required to qualify the packaging and the packaged drug product depends on the risk that leached substances could adversely affect drug product quality; the higher the risk, the more extensive and rigorous the required qualification. Although regulatory guidance supports and advocates such a risk-based approach to chemical characterization, the existing guidance is founded on an overly simplified approach to risk assessment, leading to incongruous risk classifications for certain classes of drug products. Furthermore, the existing guidance no longer links risk to current requirements concerning the extent of chemical characterization necessary to secure regulatory approval of drug product applications. To address these circumstances, this manuscript proposes and justifies a risk classification process (risk evaluation matrix) for drug products and packaging and a risk-based approach to chemical characterization requirements, linking risk to the degree and rigor of the chemical characterization process and establishing chemical characterization requirements for individual risk classes.

Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson's Patients Using Digital Mobility Outcomes.

Wearable inertial sensors can be used to monitor mobility in real-world settings over extended periods. Although these technologies are widely used in human movement research, they have not yet been qualified by drug regulatory agencies for their use in regulatory drug trials. This is because the first generation of these sensors was unreliable when used on slow-walking subjects. However, intense research in this area is now offering a new generation of algorithms to quantify Digital Mobility Outcomes so accurate they may be considered as biomarkers in regulatory drug trials. This perspective paper summarises the work in the Mobilise-D consortium around the regulatory qualification of the use of wearable sensors to quantify real-world mobility performance in patients affected by Parkinson’s Disease. The paper describes the qualification strategy and both the technical and clinical validation plans, which have recently received highly supportive qualification advice from the European Medicines Agency. The scope is to provide detailed guidance for the preparation of similar qualification submissions to broaden the use of real-world mobility assessment in regulatory drug trials.

CN2 The roadmap of oncology nursing specialisation in Spain

This is a study that aimed to identify the profile of the nurse who works in the oncology units in clinical trials, radiotherapy, oncohaematology, primary care, palliative care, paediatrics, etc., both professionally and in education, and to identify the need for professional development through specialisation. Within the framework of the importance of the specialization of the oncology nurse, we found few studies that explore the situation of oncology nursing, and what the interests and educational needs are. Our objective was to identify the formative needs and professional development of oncology nurses in Spain. Descriptive study carried out by means of a semi-open survey conducted among the attendees of the National Congress of Oncology Nursing. The profile of the oncology nurse who attends conferences is a female nurse, between 30 and 60 years old, with more than 10 years of experience in oncology. Most of them comment on feeling supported by their organization in terms of access to training and attendance to scientific activities. Sixty-eight per cent of the nurses said that they needed to specialise in oncology, and among the educational needs detected were those related to immunotherapy and the latest treatments, as well as everything related to side effects. Issues related to safety, research and nursing leadership also stand out. Professional experience as well as specialized qualifications are important aspects to consider when establishing a profile of the nurse working in the field of oncohematology. The responsibility in the assistance in the treatments, prevention and care, makes necessary the acquisition of competences, attitudes and specific aptitudes for the performance of our work. It is important that studies and consensus documents be expanded to highlight the need for training and specialization of nurses with a critical and reflective perspective in the approach to care and to establish strategies for the official qualification of these professionals.

Perfil dos profissionais da Atenção Básica no Município de Araranguá/SC

Com avanços nos campos científicos, tecnológicos, mudanças dos modelos assistenciais e das necessidades de saúde da população, nota-se a importância de renovar e ampliar os conhecimentos da equipe multiprofissional que atua na Atenção Básica, pois se exige cada vez mais um profissional capacitado para atender as necessidades em saúde do usuário e do serviço. Este estudo objetivou investigar as características sociodemográficas, de formação e qualificação dos profissionais de saúde que atuam na Atenção Básica do município de Araranguá/SC. Estudo descritivo, quantitativo e transversal, que foi aplicado aos profissionais de saúde, utilizando um questionário estruturado para coleta de dados. Participaram da pesquisa 56 profissionais de saúde, sendo que destes, 46,4% são do sexo feminino, 57% encontram-se na faixa etária entre 31 a 40 anos, 62,5% tem especialização, 78,5% realizaram algum tipo de capacitação nos últimos cinco anos. Os resultados deste estudo demonstram que os profissionais de saúde atuantes em Araranguá buscam realizar especializações e capacitações, o que é importante para o aperfeiçoamento profissional e para mudanças na prática nos serviços. Apoiado no fato dos profissionais já buscarem qualificação, sugere-se o incentivo em capacitações como uma estratégia de qualificação da Rede de Atenção Básica do Município de Araranguá. A parceria com instituições formadoras têm papel fundamental, no sentido de reafirmar a importância da interação ensino-serviço-comunidade, inclusive com a inserção de estudantes de cursos da área em cenários de prática, bem como de investimentos em programas de residência multiprofissional.

Educação permanente em saúde nos serviços de urgência e emergência: uma revisão integrativa

Objetivo: Analisar como a educação permanente em saúde vem sendo empregada como estratégia de qualificação das equipes dos serviços de urgência e emergência. Método: Revisão Integrativa da Literatura, realizada através de cinco bases de dados e uma biblioteca digital, tendo como critérios de inclusão: tipos de estudo, idioma e recorte temporal. A amostra final foi composta por 11 estudos. Resultados: Como resultado da síntese de evidencia, emergiram duas categorias temáticas: “A relevância da Educação Permanente como estratégia para a qualificação profissional nos serviços de urgência e emergência” e “Métodos empregados na implementação da Educação Permanente nos serviços de urgência e emergência”. Conclusão: A revisão integrativa se fez eficaz, apontando a relevância da educação permanente para a qualificação e desempenho profissional, permitindo perceber a importância desta ser mais estimulada e incorporada aos serviços de urgência e emergência, e ressaltando que esta proporcionará habilidades e melhor eficiência no atendimento ao usuário. Foi possível observar que os diversos métodos que estão sendo empregados visando a implementação dessa prática educacional, destacando-se o uso da tecnologia associada a mesma. As evidências obtidas podem ser úteis às discussões sobre a temática e nas futuras pesquisas.

Fundamental Principles, Processes, and Roles of Environmental Qualification Test Strategy for Complex Engineered Systems

“In real life, strategy is actually very straightforward. You pick a general direction and implement it like hell.” Jack Welch Former CEO of General Electric. A qualification strategy, created and executed on complex systems, enables effective and efficient environmental testing at the component, unit, section and system levels. Cost, schedule, and technical challenges highlight the need for an environmental qualification test strategy that provides a robust test regime to verify the design meets user requirements, balanced with a timesaving approach. This paper explains three fundamentals to follow when creating an environmental qualification test strategy that cover risk reduction testing, test planning, and test design. Based on lessons learned through two decades of results, the strategies described in the fundamentals provide an optimized approach to qualification by; 1) demonstrating test environment capabilities as risk reduction, 2) defining key stakeholders, roles and responsibilities along with methods to reduce the possibility of increased test durations due to setup inefficiencies, and 3) providing methods to ensure the required test coverage and test methodology is robust enough to detect design deficiencies. This strategy aligns with customer desire to reduce test delays while at the same time not sacrificing test thoroughness.

A Qualified Success: Discovery of a New Series of ATAD2 Bromodomain Inhibitors with a Novel Binding Mode Using High-Throughput Screening and Hit Qualification.

The bromodomain of ATAD2 has proved to be one of the least-tractable proteins within this target class. Here, we describe the discovery of a new class of inhibitors by high-throughput screening and show how the difficulties encountered in establishing a screening triage capable of finding progressible hits were overcome by data-driven optimization. Despite the prevalence of nonspecific hits and an exceptionally low progressible hit rate (0.001%), our optimized hit qualification strategy employing orthogonal biophysical methods enabled us to identify a single active series. The compounds have a novel ATAD2 binding mode with noncanonical features including the displacement of all conserved water molecules within the active site and a halogen-bonding interaction. In addition to reporting this new series and preliminary structure-activity relationship, we demonstrate the value of diversity screening to complement the knowledge-based approach used in our previous ATAD2 work. We also exemplify tactics that can increase the chance of success when seeking new chemical starting points for novel and less-tractable targets.

The effect of primary processing parameters on surface roughness in laser powder bed additive manufacturing

Metal additive manufacturing (AM) is a method to create complex components in a layer-by-layer process. Laser powder bed fusion (LPBF) provides the ability to fabricate complex designs. Components with internal geometries have surfaces that are difficult to improve through post-processing and have been shown to be detrimental to mechanical performance. This work investigates the relationship between primary processing parameters, and surface roughness of nickel-based superalloy 718 fabricated on a LPBF AM machine. The surface roughness of components built using varied contour processing parameters was characterized using both nondestructive and destructive measurement techniques. Statistical correlations are presented between contour processing parameters and surface roughness height metrics along with general trends in the relationships. Results show that the destructive measurements are required to expose notch-like features that are obstructed by powder particles attached to the surface. However, nondestructive methods more easily provide a statistically significant sample size. Understanding the surface roughness can be used for further process optimization and to inform the qualification strategy for AM components.

Noble Metal Nanoparticle-Based Multicolor Immunoassays: An Approach toward Visual Quantification of the Analytes with the Naked Eye.

Noble metal nanoparticle-based colorimetric sensors have become powerful tools for the detection of different targets with convenient readout. Among the many types of nanomaterials, noble metal nanoparticles exhibit extraordinary optical responses mainly due to their excellent localized surface plasmon resonance (LSPR) properties. The absorption spectrum of the noble metal nanoparticles was mostly in the visible range. This property enables the visual detection of various analytes with the naked eye. Among numerous color change modes, the way that different concentrations of targets represent vivid color changes has been brought to the forefront because the color distinction capability of normal human eyes is usually better than the intensity change capability. We review the state of the art in noble metal nanoparticle-based multicolor colorimetric strategies adopted for visual quantification by the naked eye. These multicolor strategies based on different means of morphology transformation are classified into two categories, namely, the etching of nanoparticles and the growth of nanoparticles. We highlight recent progress on the different means by which biocatalytic reactions mediated LSPR modulation signal generation and their applications in the construction of multicolor immunoassays. We also discuss the current challenges associated with multicolor colorimetric sensors during actual sample detection and propose the future development of next-generation multicolor qualification strategies.

The influence of additive manufacturing processing parameters on surface roughness and fatigue life

Additive manufacturing (AM) is used to create metal components with complex geometries where the internal surfaces cannot easily be post machined. Fatigue behavior in additively manufactured metals is largely driven by defects in the material such as porosity and surface roughness. This work investigates the processing-structure-property-performance (PSPP) relationship for varied contour processing parameters, and the resulting surface roughness features for alloy 718 fabricated using the laser powder bed fusion AM process. Two nondestructive characterization methods are used to determine the relationships between contour parameters and surface roughness characteristics. The benefits of each characterization technique and metrics required for an accurate representation of the additively manufactured surfaces are discussed. Axial fatigue testing is performed to connect the entire PSPP relationship. An understanding of the PSPP relationship with respect to surface roughness features and fatigue life can be used to guide future process parameter optimization and to inform the qualification strategy for AM components.

Development and qualification of additively manufactured parts for space

Additive manufacturing fabricates the desired final part by depositing and fusing layer upon layer of the source material and offers both benefits and disadvantages compared to traditional manufacturing. New engineering designs are possible in which a single optimized part with topology can replace several traditional parts. The complex physics of metal deposition leads to variations in quality and to new flaws and residual stresses not seen in traditional manufacturing. Additive manufacturing currently has gaps in knowledge. Mission assurance for the space industry will require: qualification and certification standards; sharing of data in handbooks; predictive models relating processing, microstructure and properties; and development of closed loop process control and nondestructive evaluation to reduce variability. A tailored qualification strategy for additive manufacturing accounts for the manufacturing readiness level, mission risk class, and the knowledge of material properties. Three case studies are presented on the development and qualification of AM for the space industry with the common goals of maturing the technology and improving its reliability.

Lean Smart Maintenance\u2014Value Adding, Flexible, and Intelligent Asset Management

Maintenance is a strategic factor and a key enabler for smart production. Therefore, it needs to be intelligent – smart – and cost efficient – lean. The Lean Smart Maintenance (LSM) management concept combines these two perspectives and enables a value adding, efficient, and intelligent asset management for production with digitalization aspects. This paper introduces LSM and explains its major components. LSM consists of efficiency drivers, e. g. maintenance processes and planning, outsourcing, and effectiveness factors, e. g. data and knowledge management, qualification and maintenance strategy. The implementation of the instruments in a four loop controlling cycle with vertical data integration is important. Furthermore, a LSM implementation model is introduced. A LSM assessment methodology as implementation step is briefly explained. A maturity model is used to identify and improve the current state of asset management. The four step LSM implementation model is described.

Agroindústrias familiares: um estudo comparativo entre Regiões do Brasil e Itália

The objective of this work is to investigate, comparatively, family agroindustries in Brazil (Rio Grande do Sul) and Italy (Tuscany), in order to perceive their differences in relation to the central aspects of their processes of social and economic reproduction. In this sense, indicators were evaluated on the origin of agroindustries, processed products, markets and marketing channels built, public support policies and programs, as well as agri-food legislation governing the production, distribution and consumption of food. The methodology used was qualitative research, through the application of fourteen semi-structured interviews. Qualitative and quantitative data and information from various secondary sources were also used. The results and conclusions point to interesting differences between the two regional realities, such as the: different agrifood qualification strategies, the way in which markets are socially constructed and the possibilities of social actors to generate innovations in agroindustries and the environment institutional context in which they are embededdness.

Qualification Strategy of New Technologies for Safety Instrumentation in Harsh Radiation Environments

Qualification of safety instrumentation for nuclear reactors is a challenging issue in harsh radiation environments; the task is further complicated when new technologies are introduced. In this paper, we present two qualification strategies for new developments qualified to the highest safety standards. In the first case study, we develop a qualification method that quantifies the aging rate of a polymer during different aging steps, thus paving the way to predictive maintenance for safety qualified instrumentation. In the second case study, we propose a qualification strategy for a fiber optic-based probe which is supposed to implement a safety function in an extreme radiation environment that will expose the probe to 800 MGy over its lifetime.

A High-Throughput Dose-Response Cellular Thermal Shift Assay for Rapid Screening of Drug Target Engagement in Living Cells, Exemplified Using SMYD3 and IDO1

A persistent problem in early small-molecule drug discovery is the frequent lack of rank-order correlation between biochemical potencies derived from initial screens using purified proteins and the diminished potency and efficacy observed in subsequent disease-relevant cellular phenotypic assays. The introduction of the cellular thermal shift assay (CETSA) has bridged this gap by enabling assessment of drug target engagement directly in live cells based on ligand-induced changes in protein thermal stability. Initial success in applying CETSA across multiple drug target classes motivated our investigation into replacing the low-throughput, manually intensive Western blot readout with a quantitative, automated higher-throughput assay that would provide sufficient capacity to use CETSA as a primary hit qualification strategy. We introduce a high-throughput dose-response cellular thermal shift assay (HTDR-CETSA), a single-pot homogenous assay adapted for high-density microtiter plate format. The assay features titratable BacMam expression of full-length target proteins fused to the DiscoverX 42 amino acid ePL tag in HeLa suspension cells, facilitating enzyme fragment complementation–based chemiluminescent quantification of ligand-stabilized soluble protein. This simplified format can accommodate determination of full-dose CETSA curves for hundreds of individual compounds/analyst/day in replicates. HTDR-CETSA data generated for substrate site and alternate binding mode inhibitors of the histone-lysine N-methyltransferase SMYD3 in HeLa suspension cells demonstrate excellent correlation with rank-order potencies observed in cellular mechanistic assays and direct translation to target engagement of endogenous Smyd3 in cancer-relevant cell lines. We envision this workflow to be generically applicable to HTDR-CETSA screening spanning a wide variety of soluble intracellular protein target classes.