Driving Consistency in Validation Management

FDA also explained that system designs and controls should allow for detecting errors, omissions, and unusual results-outcomes that cannot be easily identified with paper-based processes. Because the guidance requirements for record retention and review don't differ between paper or electronic, this update supports the shift to a digital model. Using paper to check and mark things off is a normal practice in life sciences, even if it is not a very good process for error detection, data collection, or metrics, says Bryony Borneo, quality assurance director at global contract research organization (CRO) Emmes. Building a solid data foundation and gaining more experience with remote ways of working are driving positive change and making it easier for quality teams to remain compliant with regulations. According to Sanjeev Kumar, senior director, data integrity and technology at Vertex Pharmaceuticals, there is greater awareness of data standardization to identify developing trends and insights from information.

The Key Elements for Assay Transfer Success

[...]the sheer volume of developers working in the space across a range of modalities (including recombinant viral vectors, live attenuated vaccines, recombinant proteins, and nucleic acids), using different methods of data collection and evaluation, made comparison of immune responses to find the most effective candidates extremely challenging. [...]this includes an assay overview to ensure that everyone involved in the analyses is aligned with how each assay is being performed in the reference labs and understands the limitations of the assays. [...]a laboratory comparison assessment and an assay performance evaluation at the recipient labs were completed to ensure that the quality of the assays was not impacted by the transfer. Since the arrival of the wild-type SARS-CoV-2 virus in 2019, the COVID-19 global landscape has continued to evolve with the emergence of new variants of concern.

Surgical plume and its associated hazards to perioperative staff: A review of current standards for practice and risk management

Surgical plume poses a risk to perioperative nurses and the perioperative team as a whole, as well as the operative patient. Surgical plume contains various hazardous components which pose multiple health risks to the perioperative staff who are exposed to it. Further research is required in order to definitively understand the risks to perioperative staff from long-term exposure to surgical plume and to advance current policies and procedures. The current practice standard on surgical plume management from the Australian College of Perioperative Nurses (ACORN) sets out methods of reducing these risks. However, this standard's utility in practice and barriers to its implementation lead to ongoing unnecessary plume exposure. Through adhering to current practice standards and educating perioperative nurses, the risks posed by surgical plume can be mitigated. Thorough education on this topic will empower nurses to advocate for their safety and the safety of their patients, leading to the reduction of surgical plume exposure.

Regulating Digital Therapeutics

Conversely, in Italy DTx are classed as medical devices and must pass International Organization for Standardization (ISO) standards to ensure they are compliant with safety requirements. The new EU MDR should help to simplify the exchange of data on medical devices and improve data collection and post-market surveillance to reinforce end-user confidence in DTx solutions. In Germany, Ireland, and the Netherlands, DTx manufacturers have directly targeted self-insured employer health plans, whereas in France, Belgium, and the United Kingdom, a B2P reimbursement model has proven successful.

Biologic Standards in the Pharmacopoeias: An Update

[...]ustekinumab concentrated solution and ustekinumab injection are the first IL-12/IL-23 inhibitors to be studied by EDQM for monograph development via the P4 process (13). First "horizontal standard" for biotherapeutic monographs Today, there are several TNF-alpha inhibitor products available, and manufacturers have used a wide variety of methods to assess the potency of these mAbs. Two other horizontal standards are currently being elaborated by EDQM: "Capillary Isoelectric Focusing for Recombinant Therapeutic ~ Monoclonal antibodies (2.5.44)" and "Size Exclusion Chromatography for Recombinant Therapeutic Monoclonal Antibodies (2.5.43)" (19). The final change to CGT standards is to general chapter "Raw Materials of Biological Origin for the Production of Cell-based Therapy Medicinal Products (5.2.12)."

Randomized regulation: the impact of minimum quality standards on health markets

We report results from the first randomization of a regulatory reform in the health sector. The reform established minimum quality standards for patient safety, an issue that has become increasingly salient following the Ebola and COVID-19 epidemics. In our experiment, all 1348 health facilities in three Kenyan counties were classified into 273 markets, and the markets were then randomly allocated to treatment and control groups. Government inspectors visited health facilities and, depending on the results of their inspection, recommended closure or a timeline for improvements. The intervention increased compliance with patient safety measures in both public and private facilities (more so in the latter) and reallocated patients from private to public facilities without increasing out-of-pocket payments or decreasing facility use. In treated markets, improvements were equally marked throughout the quality distribution, consistent with a simple model of vertical differentiation in oligopolies. Our paper thus establishes the use of experimental techniques to study regulatory reforms and, in doing so, shows that minimum standards can improve quality across the board without adversely affecting utilization.

Improving conditions or conditional improvements? A modern code, and mode, of I-O ethics

Three categories of modern dilemmas are immediately apparent in relation to reimagining and committing to a more proactive code in I-O, given their overlap with contemporary issues in technology and data management, health and accessibility, and justice, equity, diversity, and inclusion: ethical use of assessments (e.g., AI in selection);ethical conduct of research and data analysis;and ethical imperatives for fairness, inclusiveness, wellness, and equity in organizations, particularly in light of recent world events (e.g., the COVID-19 pandemic, social justice movements, inflation and economic challenges). Algorithms are then bound by the quality (and bias) incorporated into the data upon which they are trained and tested. [...]with the regulatory landscape in flux, it becomes even more important to utilize an ethical code to develop assessments. [...]relatedly, I-O psychologists who conduct research in organizations may not have regulatory oversight (e.g., institutional review board governance, peer review processes, expectations for pre-registration and open science practices) to guide their studies;if present and applicable, regulatory oversight may still be mismatched with organizational research, often ill fitted to certain types, disciplines, and contexts, or only focused on particular elements or stages of the research process while neglecting others (e.g., Bell & Wray-Bliss, 2009;Buchanan & Bryman, 2009;Greenwood, 2016). [...]I-O psychologists may also find themselves in ethical dilemmas as workers return to the office post pandemic. [...]proactive behavior is more likely and important within uncertain contexts, particularly those

Pareto-Optimized AVQI Assessment of Dysphonia: A Clinical Trial Using Various Smartphones

Multiparametric indices offer a more comprehensive approach to voice quality assessment by taking into account multiple acoustic parameters. Artificial intelligence technology can be utilized in healthcare to evaluate data and optimize decision-making processes. Mobile devices provide new opportunities for remote speech monitoring, allowing the use of basic mobile devices as screening tools for the early identification and treatment of voice disorders. However, it is necessary to demonstrate equivalence between mobile device signals and gold standard microphone preamplifiers. Despite the increased use and availability of technology, there is still a lack of understanding of the impact of physiological, speech/language, and cultural factors on voice assessment. Challenges to research include accounting for organic speech-related covariables, such as differences in conversing voice sound pressure level (SPL) and fundamental frequency (f0), recognizing the link between sensory and experimental acoustic outcomes, and obtaining a large dataset to understand regular variation between and within voice-disordered individuals. Our study investigated the use of cellphones to estimate the Acoustic Voice Quality Index (AVQI) in a typical clinical setting using a Pareto-optimized approach in the signal processing path. We found that there was a strong correlation between AVQI results obtained from different smartphones and a studio microphone, with no significant differences in mean AVQI scores between different smartphones. The diagnostic accuracy of different smartphones was comparable to that of a professional microphone, with optimal AVQI cut-off values that can effectively distinguish between normal and pathological voice for each smartphone used in the study. All devices met the proposed 0.8 AUC threshold and demonstrated an acceptable Youden index value.

Fighting disinformation through source management: a comparison between journalistic models in the context of COVID-19

Introducción: La "pandemia" de la desinformación ha marcado la cobertura periodística del COVID-19, por lo que resulta de interés ver cómo diferentes modelos periodísticos han empleado la gestión de fuentes como criterio de calidad para hacerle frente. Metodología: El presente trabajo analiza las fuentes periodísticas - desde los indicadores de número, identificación y tipologíaempleadas en 420 artículos sobre la cobertura del COVID-19 correspondientes a cuatro modelos profesionales periodísticos: prensa tradicional, medios nativos digitales, prensa popular y plataformas de verificación. Resultados: El análisis refleja una adecuada gestión por parte de la prensa española de las fuentes durante la cobertura de la pandemia, utilizando de forma mayoritaria un número de fuentes superior al estándar;identificándolas correctamente en la práctica totalidad de casos;y empleando una adecuada variedad. Así, pese al claro predominio de las fuentes oficiales, se da también una presencia notable de fuentes expertas de los ámbitos científico y sanitario. Discusión y conclusiones: La calidad en la gestión de fuentes ha contribuido a hacer frente a la desinformación por parte de la prensa española, si bien se detectan importantes diferencias entre modelos profesionales. Las plataformas de verificación son las que presentan unos estándares de calidad más elevados a la hora de gestionar sus fuentes informativas, lo que contribuye a reforzar criterios claves en la lucha contra la desinformación como son verificación, relevancia, credibilidad y transparencia.Alternate :Introduction: The pandemic of misinformation has shaped the journalistic coverage of COVID-19, so it is interesting to see how different journalistic models have used source management as a quality criterion to address it. Methodology: This paper analyses the journalistic sources - from the indicators of number, identification and typology - used in 420 articles on the coverage of COVID-19 corresponding to four journalistic professional models: traditional press, digital native media, popular press and verification platforms. Results: The analysis reflects an adequate management of sources by the Spanish press during the coverage of the pandemic, mostly using a higher than standard number of sources;identifying them correctly in almost all cases;and using an adequate variety. Therefore, despite the clear predominance of official sources, there is also a notable presence of expert sources from the scientific and health fields. Discussion and conclusions: The quality of source management has contributed to fighting disinformation in the Spanish press, although there are important differences between professional models. Verification platforms are those with the highest quality standards when managing their information sources, which helps to reinforce key criteria in the fight against disinformation, such as verification, relevance, credibility and transparency.

Global Atmospheric Composition Needs from Future Ultraviolet–Visible–Near-Infrared (UV–Vis–NIR) NOAA Satellite Instruments

Presentations spanned a range of applications: the public health impacts of poor air quality and environmental justice;greenhouse gas measuring, monitoring, reporting, and verification (GHG MMRV);stratospheric ozone monitoring;and various applications of satellite observations to improve models, including data assimilation in global Earth system models. The combination of methane (CH4), carbon dioxide (CO2), carbon monoxide (CO), and NO2 retrievals can improve confidence in emissions inventories and model performance, and together these data products would be of use in future air quality management tools. The ability to retrieve additional trace gases (e.g., ethane, isoprene, and ammonia) in the thermal IR along with those measured in the UV–Vis–NIR region would be extremely useful for air quality applications, including source apportionment analysis (e.g., for oil/natural gas extraction, biogenic, and agricultural sources). Ground-level ozone is one of six criteria pollutants for which the EPA sets National Ambient Air Quality Standards (NAAQS) to protect against human health and welfare effects.

Managing Building Water Disruptions in a Post-COVID World: Water Quality and Safety Risk Assessment Tool for Academic Institutions and School Settings

Fluctuating building occupancy during the COVID-19 pandemic contributed to poor water quality and safety conditions in building water distribution systems (BWDSs). Natural disasters, man-made events, or academic institutional calendars (i.e., semesters or holiday breaks) can disrupt building occupant water usage, which typically increases water age within a BWDS. High water age, in turn, is known to propagate poor water quality and safety conditions, which potentially exposes building occupants to waterborne pathogens (e.g., Legionella) associated with respiratory disease or hazardous chemicals (e.g., lead). Other influencing factors are green building design and municipal water supply changes. Regardless of the cause, an increasing number of water management policies require building owners to improve building water management practices. The present study developed a Water Quality and Safety Risk Assessment (WQSRA) tool to address gaps in building water management for academic institutions and school settings. The tool is intended to assist with future implementation of water management programs as the result of pending policies for the built environment. The WQSRA was modeled after water management practices created for controlling water contaminants in healthcare facilities. Yet, a novel WQSRA tool was adapted specifically for educational settings to allow building owners to evaluate risk from water hazards to determine an appropriate level of risk mitigation measures for implementation. An exemplar WQSRA tool is presented for safety, facility, industrial hygiene, and allied professionals to address current gaps in building water management programs. Academic institutions and school settings should examine the WQSRA tool and formulate an organization-specific policy to determine implementation before, during, and after building water-disruptive events associated with natural or man-made disasters.

Effect of Replacing Feldspar by Philippine Black Cinder on the Development of Low-Porosity Red Stoneware

Stoneware is a ceramic material with low porosity and high mechanical properties, such as the modulus of rupture. It is essentially made of clay, feldspar and quartz and is sintered to create a mixture of glass and crystalline phases. With the projected growth rate of the global ceramics market size and the country's development plan for 2023–2028, it is imperative that alternative raw materials for the manufacture of ceramic products be sourced so that the importation of these materials, such as feldspar, be minimized, if not eliminated. Cinder in the Philippines is mainly used as a filling material in pavements and residential areas. In this study, this resource is utilized as partial and full replacement of feldspar in a typical ternary diagram for stoneware production. Bars were formed from different formulations by the slip casting method and were sintered at 1200 °C. Physical and mechanical properties of the bars, such as shrinkage, loss on ignition, water absorption, apparent porosity and modulus of rupture were determined. Thermo-physical analyses were also carried out on the raw materials and on formulated powders. Meeting the requirements of the various quality standards for ceramics, the partial replacement of feldspar with black cinder (LF, LFBQ and LFBH) is feasible for wall and roof applications while full replacement of feldspar with black cinder (LB) is suitable for wider use as wall, floor, vitrified, industrial and roof tiles.

MODERN STATE POLICY IN THE HEALTHCARE SECTOR

A forma&cccedil;ão e o controle do mercado de saúde é uma prioridade para o setor público, o que pode melhorar a qualidade da implementacjo da política nacional do Estado neste segmento. O uso de ferramentas de alta qualidade para implementat a política estatal no setor da saúde pode melhorar o estado atual da proteção social e estabilizar a situação existente no país. O artigo visa analisar medidas, programas e instrumentos eficazes para a fotmaçâo e desenvolvimento da política estatal no campo da saúde, considerando a experiencia dos países desenvolvidos e as realidades ucranianas. O uso de uma metodologia eficaz para o desenvolvimento de políticas de saúde pública é importante porque ajuda a melhorar o padrâo de vida da populaçao. Além disso, ela fortalece a economia do país, dado o desenvolvimento do setor empresarial, dos mercados de commodities e o desenvolvimento da cooperaçâo internacional em saúde e intercambio de tecnología. Os resultados do estudo podem ser úteis para otimizar a atual política estatal no campo da assisténcia â saúde. Além disso, eles podem ser utilizados racionalmente no setor público de reclusos políticos e administrativos disponíveis. O artigo analisa o estado do setor de saúde e pıopöe açöes efetivas para o desenvolvimento futuro da política estatal neste segmento.Alternate abstract:The formation and control of the healthcare market is a priority for the public sector, which can improve the quality of implementation ot the state's domestic policy in this segment. The use of high-quality tools for implementing state policy in the healthcare sector can improve the current state of social protection and stabilize the existing situation in the country. The article aims to analyze effective measures, programs, and instruments for the formation and development of state policy in the field of healthcare, considering the experience of developed countries and Ukrainian realities. Using an effective methodology for the development of public health policy is important because it helps to improve the standard of living of the population. Moreover, it strengthens the country's economy, given the development of the corporate sector, commodity markets, and the development of international cooperation in healthcare and technology exchange. The results of the study may be useful for optimizing the current state policy in the field of health care. Besides, they can be rationally used in the public sector of available political and administrative resources. The article analyzes the state of the healthcare sector and proposes effective actions for further development of the state policy in this segment.

Hotel Recovery Post Pandemic: Is Rebranding Required?

For hotel business to survive during COVID-19 Pandemic requires to conduct major adjustment in almost all aspects of operation. This qualitative study was conducted to assess the operation adiustment that may affect the hotel brand. Data was gathered from respondents comprising managers and decision-makers of 5-to-3-star hotels in Bali, Indonesia that remain open during the pandemic, using online survey and interview. The results show that during the pandemic, hotels have made major operation adjustment to survive;whilst, maintaining the same quality standard, applying meticulous CHSE (Cleanliness Health Safety Environment) protocol, and keeping the customers informed through online promotion platforms regarding the hotel's condition being ready to host guests. The adjustment made includes reducing operation cost, shifting target market into domestic market to maintain cash flow to cover operation, adjusting the rate and prices to adapt the weaker customer's buying power, applying flexible booking and refund conditions, human resource policy and planning rearrangement, reducing the quantity of room offered and menu list items in Food and Beverage outlets. The hotel business resilient was owned to the professionalism of hoteliers, thus hotel rebranding is not required as the quality of the products offered is the same with those before the pandemic;at post-pandemic, it would be simply sifting the target market back to pre-pandemic.

Investigation of Changes in Atmospheric Pollutants due to the Cessation of Anthropogenic Activities: Spatial Heterogeneity and Complex Atmospheric Chemistry

The current study examines the air quality trends in response to Covid-19-induced lockdowns at various locations in Delhi. The primary pollutants like NO2, CO, and PM10 have shown reductions during the lockdown phase, but the magnitude varied significantly in different places. Also, during the lockdown, air quality in some areas of Delhi exceeded National Ambient Air Quality Standards. Secondary pollutants like O3 have shown mixed trends due to complex atmospheric processes and dependence on relative proportions of VOC and NOx levels. A total of six sites, including traffic, industrial, and residential sites, have been studied. The diurnal behavior of pollutants also differed significantly around different places. During the lockdown, Ashok Vihar, a traffic-influenced area, showed a decrease in O3 (~ 40%), while at DTU (Traffic site), O3 levels increased (~ 48%). The industrial sites Okhla and Wazirpur also showed different trends during the lockdown;O3 in Wazirpur decreased by 50%, whereas Okhla increased by 25%. NOx concentration was lesser in 2020 at all the stations compared to 2019, indicating the positive impact of the lockdown on air pollution due to vehicular emissions. The Approximate Envelope Method estimates the secondary fraction of PM2.5. This fraction of PM is dominated in the lockdown year in the residential site, while it remains unchanged in the traffic site and increased by 11% in the industrial area. Despite being not so far from each other, these sites show very different patterns of pollutants during lockdown episodes. © 2023, The Author(s) under exclusive licence to Institute of Earth Environment, Chinese Academy Sciences.

Impact of lockdown Covid-19 pandemic on himalayan environment

The COVID-19 Pandemic have caused severe impact on lives in various ways, but our environment has experienced a positive outcome due to the lockdown which was imposed all over world including Himalayan region of India. The worldwide spread of COVID 19 has reduced movement of vehicles, industries and all tourism activities. Due to shutdown of all the commercial activities and traffic has helped the environment to reclaim naturally. The Himalayas is one of the world's most fragile and sensitive hotspots to global climate change, with impacts manifesting at a particularly rapid rate. The Himalayan glaciers are the water towers of Asia, and the source of many of the world's great rivers. In this research paper, an attempt has been made to describe the improvement in physiochemical characteristics of surface water, all parameters were compared with BIS standard of drinking water quality during pre lockdown and lockdown period. The ambient air quality have also been significantly improved and noise level were also found under permissible limit of Ambient air quality Standard.

Lessons learned during Covid-19 from engineering asset management of dams

Public and private owners of critical infrastructures all over the world are taking high-quality standards to face the consequences of pandemics, particularly critical infrastructure such as dams that needs more attention to maintain and operate during coronavirus disease (Covid-19) pandemics. In this study, critical strategies have been identified through literature review and with the support of experts' opinions. The rough Decision-making Trial and Evaluation Laboratory and interpretive structural modelling methods were integrated to determine the most important strategies that were identified by literature review and experts' opinions. Moreover, the methodology was used to find the relationships, cause and effect between the critical strategies. Interviews were completed with professional managers and experts in the field of dam operation and maintenance to help in finding the influence degree between these critical strategies. Among 11 initial strategies, six critical strategies were selected for this study from the experts' points of view. By applying Matriced Impacts Croisés Multiplication Appliquée á un Classement analysis, driving and dependence powers were also determined and classified for these strategies. The outcomes indicate that the strategy of reviewing emergency action plans and planning for how routine and unplanned work will be implemented during pandemic staffing restrictions is the most driving among these strategies in dam asset management in Canada during pandemics. © 2021 ICE Publishing: All rights reserved.

Regulation Number 5 Of 2020 Concerning Standards for Organizing Balinese Cultural Tourism to Promote Sustainable Village-Based Tourism

The current study aimed at analyzing and conceptualizing the Government Regulation number 5 of 2020 concerning Standards for Organizing Balinese Cultural Tourism and compare it with other regulations in the neighborhood countries, including that of Timor Leste. The study found that the Bali Regulation under study was promulgated to ensure the sustainability of Balinese Cultural Tourism and uphold its cultural values, natural environment, customs, spiritualism, maritime and local wisdom of the community. complementing and combining the physical characteristics of village-based tourism destinations between Bali and Timor Leste regions in order to increase tourism which was heavily impacted during the pandemic. The study made a normative and empiric legal analysis of the Bali Provincial Regulation No. 5/2020 concerning the Standard for the Implementation of Balinese Cultural Tourism and the relevant Timor Leste regulation by utilizing comparative research approach. The rationale behind this study was to find ways how to develop village-based tourism destinations on urgent basis as the livelihood of the people in Bali and Timor Leste is critically dependent on tourism. The data was collected from library resources, legislations, journal articles, and legal archives. The study found that various legislations including Bali Provincial Regulation No 5 of 2020 concerning with the Standards for Balinese Cultural Tourism Implementation encouraged equal business opportunities and equal benefits to face the challenges of changing local, national and global life amidst the pandemic. However, now there is a need to establish business quality, services, processes, systems and / or services to tourists that meet standards, business qualification requirements, human resource competencies while not overriding the smooth running of traditional ceremonial activities as an intangible cultural heritage based on the Tri Hitakarana philosophy. The findings of the study would have useful implications on the tourism business of the two sectors under study.

Teaching Practice in the Development of Pedagogical Management: The Case of the Presidente Tamayo Basic Education School

This research assesses the development of pedagogical and administrative management within the Presidente Tamayo School of Basic Education as dimensions of the educational quality standards, considering the means of verification proposed by the Manual for the Implementation and Evaluation of Educational Quality Standards of the Ministry of Education. The pandemic caused by Covid-19 generated drastic changes in the educational system;the analysis of teaching competencies and institutional management, the use of didactic resources and the fulfillment of the guarantee of access to education for children and adolescents, were incorporated into the research project. To test the hypothesis on the quality of teaching practice, mixed research was used, generating quantitative and qualitative data;a non-experimental-correlational study, reflecting as a result;that pedagogical practices represent challenges for teachers in the remote learning modality, technological, temporal and contextual limitations were visualized in the various actors of teaching and the student in their learning process, the administrative management is also affected by the incursion in the adaptation of face-to-face management to the virtual one. In such virtue, it is inferred the need to manage pedagogical strengthening training, integrating methodologies as a didactic resource;applications, programs and interactive activities for synchronous hours classes and asynchronous activities, that is, teaching practices with an inclusive approach that do not move away from the quality demanded by the fulfillment of educational standards. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.