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"There were questions of how to handle tech transfer, factory and site acceptance tests, and regulatory inspections when the world was no longer travelling," he says. Since July, Stracquantanio says, usage of the platform has expanded by a factor of 17, and new site deployments by a factor of ten. The company is now using the remote approach with all major global regulatory agencies. Since Catalent hosts or performs more than 500 audits each year, new technology has allowed Catalent to keep pace, while observing social distancing requirements, Montano adds. Live facility tours are filmed with a 360-degree camera, and 3-D tours with a 3-D mapping camera, says Sandy Immerman, vice president of Information Technology (IT), Pharma Services. [...]this year, Immerman says, Thermo Fisher has hosted multiple regulatory inspections and more than 125 client audits, focusing efforts on current good manufacturing practice (CGMP) activities in work that has involved FDA, the European Medicines Agency, which issued formal guidance on the use of this technology last May (3), the Russian Ministry of Health (MoH), and the Swedish Medical Products Agency.
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Notably, pre-approval inspection (PAI) includes the added evaluation of authenticity of submitted data and link to dossier (1). Since 2003, EFPIA has conducted and reported an annual survey of good manufacturing practice (GMP) and good distribution practice (GDP) inspections and related International Organization for Standardization (ISO) audits to monitor inspection activity and trends in research-based industry (2-4). [...]the number of manufacturing sites without an inspection (domestic or foreign) was in the same range as in previous years (36% in 2020;26% in 2019;31% in 2018 [4]). [...]the regulatory oversight of manufacturing sites is consistent. Some key company responses from the survey questions include the fact that there was no change in the number and severity of observations reported;no significant differences in the outcome of GMP/GDP inspections or ISO-audits were reported;more than 90% of companies stated that there was no change in the number or type of observations;some shifts in observations were described by individual companies;and no challenges regarding drug shortage prevention measures were reported. [...]with paper-based inspections, some companies reported the start and end date of a paper-based inspection, even if the days in between were not used. [...]the duration of paper-based inspections was
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The quality of pharmaceutical products continued to be a focus, but many facility inspections were postponed in 2020, and US Food and Drug Administration (FDA) officials evaluated their inspection programmes during the pandemic and issued guidance for remote monitoring and other virtual activities (1-3). [...]responding to a 483 and/or warning letter requires familiarity with processes, systems, and data because a proper response should address how you are going to fix the situation observed, how you are going to prevent the situation observed from recurring, and why the situation observed did not impact the patient safety/product quality of the product that was released before the situation was corrected," says Schniepp. [...]a company must be able to demonstrate regular [documented] meetings between senior management and the quality department.
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In the short term, Sebastian Tomlin, logistics manager at Charles River, a contract research and development firm, says that time and investment in supply chain management and logistics operations are needed to expedite the movement of materials during this crisis. "By far, a cradle-to-grave supply chain with local starting materials, ingredients, and excipients for essential drug production will help to support resilient supply chains by removing the reliance on imports and driving new investments in green chemistry and Pharma 4.0 efforts." Maintaining a high safety stock of critical APIs and other materials is imperative, says Vincent Colicchio, vice-president and Head-Supply Chain and External Manufacturing for North America Generics at Dr. Reddy's Laboratories. Having a stringent process for qualifying material suppliers is also important, according to Hamilton Lenox, senior vice-president, business development at LGM Pharma, an API sourcing and supply chain management company.
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This study presents the positioning method and autonomous flight of a quadrotor drone using ultra-wideband (UWB) communication and an optical flow sensor. UWB communication obtains the distance between multiple ground stations and a mobile station on a robot, and the position is calculated based on a multilateration method similar to global positioning system (GPS). The update rate of positioning using only UWB communication devices is slow;hence, we improved the update rate by combining the UWB and inertial measurement unit (IMU) sensor in the prior study. This study demonstrates the improvement of the positioning method and accuracy by sensor fusion of the UWB device, an IMU, and an optical flow sensor using the extended Kalman filter. The proposed method is validated by hovering and position control experiments and also realizes a sufficient rate and accuracy for autonomous flight.
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This issue contains 13 articles on the use of virtual anatomy, histology and embryology in research and education;digital histological morphometry of the human pineal gland in a postmortem study, with endocrine and neurological clinical implications;an international collaborative approach to learning histology using a virtual microscope;delivery anatomy kits to help keep practical veterinary classes during the COVID-19 pandemic;how virtual animal anatomy facilitated a successful transition to online instruction and supported student learning during the coronavirus pandemic;using videos in active learning in veterinary anatomy;dissection videos as a virtual veterinary anatomy peer learning tool at the University of Tehran during the COVID-19 pandemic;a new virtual platform for teaching comparative animal neuroanatomy based on metameric slices of the central nervous system;application of student remote and distance research in neuroanatomy by mapping Dscaml1 expression with a LacZ gene trap in mouse brain;implementing a multi-colour genetic marker analysis technique for embryology education;impact of COVID-19 on student attainment and pedagogical needs when undertaking independent scientific research;extended reality veterinary medicine case studies for diagnostic veterinary imaging instruction and assessing student perceptions and examination performance and students' performance in teaching neuroanatomy using traditional and technology-based methods. 16 proceedings from the Trans-European Pedagogic Anatomy Research Group (TEPARG) Hybrid Meeting entitled "Hybrid Anatomy Education: Barriers and Enablers for Students and Educators" held in Barcelona, Spain, during 5 March 2022, are also included.
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Background: COVID-19 has spread rapidly around the world. It is necessary to study lung tissue of postmortem COVID19 patients to determine the molecular alteration particularly the role of IL-6 and IL-17 in causing fatality. Background: This study aims to determine the differences in the expressions of IL-6 and IL-17 in lung tissue of post-mortem COVID-19 patients compared to non-COVID-19 patients. This study also aimed to analyze the correlation between the expressions of IL-6 and IL-17 in lung tissue of post-mortem COVID-19 patients. Methods: This research is an observational analytic study with crosssectional approach. The samples were 15 paraffin blocks of post-mortem lung tissue biopsy of COVID-19 patients, and 15 paraffin blocks of inflammatory lung tissue biopsy or surgery of non-COVID-19 patients. IL-6 and IL-17 expressions were evaluated by immunohistochemical procedure. Result: There was a significant difference in the expression of IL-6 in the COVID-19 group and the non-COVID-19 group with a p-value = 0.001 (p < 0.05). There was a significant difference in the expression of IL-17 in the COVID-19 group and the non-COVID-19 group with p-value = 0.001 (p < 0.05). There was a significant correlation between the expressions of IL-6 and IL-17 in the COVID-19 group, with the Spearman coefficient value (rs) of 0.548 with p = 0.034 (p < 0.05). Conclusion: There are differences in the expression of IL-6 and IL-17 between COVID-19 and non-COVID-19 lung tissue. There is a significant correlation between the expressions of IL-6 and IL-17 in post-mortem lung tissue of COVID-19 patients.
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Introduction. Clinical studies during the epidemic of a new coronavirus infection caused by the SARS-CoV-2 virus confirm not only neurotropic damage to the central nervous system, but also complex immune-mediated neurological complications of COVID 19, one of which is acute necrotizing encephalopathy. Purpose of the study. Presentation of a clinical case of acute fatal necrotizing encephalopathy resulting from a severe respiratory infection probably caused by the SARS-CoV-2 virus. Research methods. Retrospective analysis of the medical history, interpretation of clinical and laboratory data, neuroimaging studies and autopsy results in a 22-year-old patient with a fatal neurological complication of a respiratory infection that occurs with bilateral polysegmental interstitial pneumonia. Conclusions. Characteristic ground-glass lung changes suggested a new coronavirus infection caused by the SARS-CoV-2 virus, despite a negative PCR result for virus RNA in a nasopharyngeal and cerebrospinal fluid swab. The rapid increase in focal and cerebral neurological symptoms, diffuse changes and edema of the brain substance according to CT scan and subsequently according to the results of autopsy, signs of systemic inflammation and changes in the coagulating blood system confirmed the changes characteristic of the "cytokine storm" and DIC syndrome developing against the background of systemic endothelitis in COVID 19.
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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.
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Background: The covid-19 pandemic has affected the health insurance industry in numerous ways.
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To meet greenhouse gas reduction targets, several countries are pursuing more ambitious policies in their buildings and construction sectors, such as introducing zero net energy/carbon building codes. Countries often report not having enough qualified staff for performing building energy code inspections and many are exploring faster, easier, and more reliable methods to check the compliance of buildings with their codes. Building inspections are a critical element for ensuring code compliance and they have traditionally been performed in person. However, in-person inspections can be labor and travel intensive, costly, and prone to human error. In this paper, the authors explore how virtual inspections, particularly in light of the recent COVID-19 pandemic, have impacted processes for building code compliance checks in jurisdictions and communities around the world. The authors collected data on four key parameters (time and financial savings, scope of inspections, changing practices and technological innovation, and benefits to consumers) from six jurisdictions and communities in five countries (Australia, Canada, Singapore, United Arab Emirates, and the United States) to analyze the impacts of virtual inspections on code compliance checks. The analysis found the greatest value from virtual inspections in geographically dispersed regions and for cities experiencing rapid building construction. The study also explored emerging technologies that are being piloted for virtual inspections. Although many of these technologies hold promise, more resources and capacity are needed to make them viable for use in building energy code inspections.
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Active inspection of Omicron variant enables rapid and effective analysis of COVID-19 variant. It can diminish the encumbrance on health systems. Detection and forecast models combine many qualities for calculation. The hazards of infection have progressed. The goal is to aid health care professionals globally in case of critical Omicron long-suffering persons, specifically in the situation of inadequate well-being means. The developed deep learning research approach was trained on the dataset of 900 verified persons (among which 500 were inveterate, to partake Omicron variant). The training test-set delimited the dataset from the succeeding days (700 verified persons, of which 300 were inveterate, to partake Omicron). The proposed research prototype spotted and forecasted Omicron examined outcomes with good correctness and little error rate using only six unique features such as gender, age = 50 ages, known traces with a disease distinct, and the presence of four preliminary medical indications. The developed research prototype notices Omicron infected cases via easy qualities retrieved through posing elementary queries or data queries. The proposed research outline can be useful, amid additional attention, to arrange to examine Omicron while checking properties are insufficient. © 2022 IEEE.
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A male Munchkin cat was brought to a small animal teaching hospital at Mahanakorn University of Technology. The patient presentation with vomiting, chronic diarrhea, and intermittent fever. From history-taking, the owner previously had a cat that was diagnosed with feline infectious peritonitis (FIP) living in the same house but had isolated in a separate area. Fecal examination revealed bacterial enteritis. Hematology and blood chemistry results shown lymphopenia, hypoalbuminemia, and low serum albumin/globulin ratio (0.3 A: G ratio). Abdominal ultrasound revealed mesenteric lymph node (MLN) enlargement and cholecystitis. Cell cytology from the liver and MLN revealed suppurative inflammation. Reverse transcription PCR (RT-PCR) was negative for the Feline coronavirus (FCoV) in the blood sample. On the 4th day of treatment, the cat developed pleural and peritoneal effusion. Thoracentesis and abdominocentesis were performed and submitted for analysis. The fluid's results were classified as modified transudate, low A: G ratio (0.3), Rivalta's test (positive), and positive for FCoV by using RT-PCR. On the 8th day of treatment, the cat died from systemic hypotension. Viscous straw yellow-colored fluid and pyogranulomatous lesions at the liver, lung, kidney, and MLN were observed from the necropsy. Histopathology's results shown severe suppurative inflammation in all the above organs. FIP was confirmed by detected FCoV antigen in the cytoplasm of macrophages in the kidney and lung tissue by immunohistochemistry staining.
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Aerial infrared (IR) thermography has been implemented in recent years, proving to be a powerful and versatile technique for performing maintenance at photovoltaic (PV) plants. Its application speed and reliability using unmanned aerial vehicles (UAVs) or drones make it extremely interesting at large PV plants, due to the associated savings in time and costs. Ground-level thermographic inspection is slower and more costly to apply, although it does provide higher optical resolution, due to being conducted closer to the PV modules being inspected. Both techniques used in combination can improve the diagnosis. An IR thermography inspection strategy is proposed for PV plants based on two stages. The first stage of the inspection is aerial, enabling thermal faults to be detected and located quickly and reliably. The second stage of the inspection is done on the ground and applied only to the most relevant incidents revealed in the first stage. This inspection strategy was applied to a 100 kW PV plant, with an improved diagnosis verified via this procedure, as the ground-level inspection detects one-off thermal incidents from objects creating shade and from solar reflections. For PV modules with open circuits or open substrings, the use of one technique or another is immaterial.
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This second edition contains 24 new and updated chapters on aetiology, epidemiology, prevalence, pathogenesis, clinical signs, treatment, prevention and control of infectious diseases in cats, dogs and exotic small companion mammals in animal shelters. These include an introduction to infectious disease management in animal shelters, wellness, data surveillance, diagnostic testing, necropsy techniques, outbreak management, pharmacology, sanitation, canine and feline vaccinations and immunology, canine infectious respiratory disease, canine distemper virus, canine influenza, feline infectious respiratory disease, canine parvovirus and other canine enteropathogens, feline panleukopenia, feline coronavirus and feline infectious peritonitis, internal parasites, heartworm disease, external parasites, dermatophytoses, zoonoses, rabies, feline leukaemia and feline immunodeficiency viruses and conditions in exotic companion mammals (ferrets, rabbits, guineapigs and rodents). It is intended for shelter veterinarians, managers and workers.
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The Big Four had about 53 audits inspected on average, which represents less than 17% of the audit reports issued for public companies during 2019, which would have been inspected in 2020. (see Exhibit 1). Because it is not feasible to inspect every audit, the PCAOB attempts to focus on audits that are more likely to be deficient. For each of the Big Four, of the 52 or 53 audits the PCAOB reviewed in 2020, 37 were risk-based selections. [...]the 20% deficiency rate is likely based on audits that were more suspect to begin with. [...]it is also important to remember that Part 1.A deficiencies for an audit firm do not necessarily lead to a significant decrease in an audit client's market value. In auditing, there is a tradeoff between minimizing errors and cost constraints (Chu, L., Fogel-Yaari, H., and Zhang, P., "The estimated propensity to issue going concern audit reports and audit quality," Journal of Accounting Auditing, & Finance, 2022, doi:10.1177/0148558X2210790H)· For example, the efforts to improve audit quahty via the StrbenesnOxley AH (SOX) innteased auditing costs;to the point of driving smaller public companies to go private (Engel, E., Hayes, R.M., and Wang, X., "The S erbanes-Oxley Act and firmi' going-private decisions3" Journal of AccounOing and Economics, vol. 44, no. 1/2, pp. 116-145, 2007). [...]we do not expect audits to be perfect;rather, we expect inspectors to discover some deficiencies.
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Scintillators as the core materials of radiation detection play an important role in industrial nondestructive testing, medical imaging, high energy physics and safety inspection, etc.. Theexisting scintillator research faces both opportunities and challenges, especially in the context of COVID-19 pandemic period. It is of great practical significance to develop cost-effective scintillators and optimize their overall performance. The nano-glass composites (i.e., glass ceramics) have some advantages like high emission efficiency of scintillator crystals, simple preparation and low cost as an effective star scintillator. Based on the different luminescence centers, such scintillators can be broadly divided into rare-earth element ions doped or rare-earth-free luminescent nanocrystals embedded materials. This review represented recent development on the preparation of these materials, the relationship between the types of nanocrystals and their luminescence properties, and the potential applications of these materials in high-energy X-ray and gamma-ray detection. In addition, the existing problems in the research were discussed and the future development direction of nano-glass composite scintillators was also prospected. © 2022, Editorial Department of Journal of the Chinese Ceramic Society. All right reserved.
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The coronavirus (COVID-19) pandemic created a new working world for businesses, accounting firms, and government. Most offices, including CPA firms and the PCAOB, pivoted to remote work. Unprecedented labor shortages meant auditors had to do the same work with fewer people. In this article, the authors examine recent PCAOB reports to investigate the pandemic's effect on the auditing profession. A focus on the reports of the largest firms, and the specific deficiencies found, permits the identification of industries that have been of greatest concern to the PCAOB. Finally, the authors discuss the changes that have taken place at the PCAOB and how they may have also impacted inspection results.
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Researchers have shown that SARS-CoV and MERS-CoV can also cause liver damage in an infected organism, but the mechanisms of injury are poorly understood. In this study, pathomorphological changes in the liver during coronavirus infection in pregnant women were studied. As material, the liver was studied at autopsy of maternal mortality from 33 coronaviruses conducted at RCPA (Republican Center for Pathological Anatomy) between 2020 and 2021. Morphological examinations of liver tissue showed that the development of various pathomorphological changes in the liver was also observed depending on the periods of coronavirus infection. In the exudative period of the coronavirus is observed a strong process of circulating in the liver, swelling, destruction and bleeding of interstitial tissue, the development of protein and hydropic dystrophy in the liver parenchyma, i.e. hepatocytes. In the second proliferative inflammatory period of the disease, there is an increase in lymphoid infiltration along the portal pathways of the liver, myxomatous metaplasia of Kupffer cells, proliferation and proliferation of fibroblasts, growth of connective tissue, portal pathways of fibrous structures, periphery and even sinusoidal wall.