Digital Commons Network^™

Quality Of Sample Testing In The Laboratory Unit: Current Situation And Strategies For Improvement, Aloyce Constantine, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

The purpose of this study was to understand the status quo of quality sample testing in the laboratory unit. A quantitative research method was used. An extensive laboratory documents (protocol, worksheets, laboratory analytical plan, standard operating procedures and manuals) review was performed and a networking approach to both management and lab staff at all levels was reviewed in order to identify all non-conformities occurred in the past three years. Results identified 36 number of results deviated from reference standards among different test performed, 400 number of samples lost, the number of laboratory personnel who were not sufficiently trained to take …

Pharmaceutical Industry In Uganda: A Review Of The Common Gmp Non-Conformances During Regulatory Inspections, Nasser Lubowa, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during …

The Impact Of Mentoring As A Gmp Capability Building Tool In The Pharmaceutical Manufacturing Industry In Nigeria, Monica Agu, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

Good Manufacturing Practices (GMP), a component of Pharmaceutical Quality Systems, is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Provision of adequate number of personnel with the necessary qualifications/practical experience and their continuous training and evaluation of effectiveness of the training is the responsibility of the manufacturer. (World Health Organization [WHO], 2014; International Organization for Standardization [ISO], 2015). The classroom method of training that has been used for GMP capacity building in the pharmaceutical manufacturing industry in Nigeria over the years, delivered by experts from stringently regulated …

Retrospective Study Of Inspectors Competency In The Act Of Writing Gmp Inspection Report, Chidi Uche, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

The research was a retrospective study of twenty-five Good Manufacturing Practice (GMP) inspection reports (from March 2017 through to December 2018) of a national medicine regulatory agency, drug Inspectorate, in West Africa, designed to assess the inspectors’ expertise in the act of inspection report writing. The investigation examined a paper-based tool of thirteen pre-registration Inspection reports and twelve GMP reassessment reports written prior and following an intervention program by external GMP trainers to enhance inspectors’ skill in pharmaceutical cGMP inspection. The study made use of quantitative analysis to investigate each team’s expertise in the act of writing GMP inspection report. …

Praising Papers, Clarifying Concerns: How Writers Respond To Praise In Writing Center Tutorials, Mike Haen

The Writing Center Journal

In face-to-face writing center tutorials, tutor praise is an action that builds rapport and motivates writers (Mackiewicz & Thompson, 2013). Drawing on and extending prior interactional analyses of praise, this article examines writers’ responses to text-based praise across 10 tutorials, with a particular focus on interactional segments in which writers reformulate their previously mentioned concerns in response to tutor praise. Unlike more common responses that signal acceptance of the praise, such as appreciation, overt acceptance, and alignment, this responding action reflects some momentary misunderstanding between tutor and writer in the tutorial interaction. Despite this, these segments also show writers taking …

Agents Of Change: African American Contributions To Writing Centers, Sue Mendelsohn, Clarissa Walker

The Writing Center Journal

African Americans and their contributions to our field’s first pedagogical models and operational structures are absent from writing center histories. This archival research invokes their presence by recounting the stories of five African American innovators—Bess Bolden “B. B.” Walcott, Coragreene Johnstone, Anne Cooke, Hugh Gloster, and Percival Bertrand “Bert” Phillips—spanning four decades at three historically Black colleges and universities (HBCUs). Their stories invite an expansive understanding of writing center work, moving beyond a focus on traditional tutoring and strictly alphabetic literacies and into “strategic literacies”—the survival skills needed to stand up for oneself and one’s community in the face of …

“Was It Useful? Like, Really?”: Client And Consultant Perceptions Of Post-Session Satisfaction Surveys, Katie Levin, Sarah Selz, Meredith Steck, Eric Wisz

The Writing Center Journal

Client satisfaction surveys have long been a cornerstone of writing center assessment, but to date, research on satisfaction surveys has largely focused on analyzing client responses from the survey and their administrative uses. Research rarely investigates why clients provide the responses they do and how consultants process these responses. This study, therefore, involved conducting separate client and consultant focus groups to learn about each population’s interactions with one writing center’s optional post-session satisfaction survey and the survey results. The findings revealed that while client participants used the survey to communicate high levels of satisfaction, client participants also thought about the …

Building Networks Of Enterprise: Sustained Learning In The Writing Center, Steve Sherwood

The Writing Center Journal

This essay examines the learning processes of writing center professionals through the lens of “networks of enterprise” (Wallace & Gruber, 1989), which reflects on the dynamic processes through which creative people, like writing center professionals (WCPs), bring together the diverse and complex tasks undertaken in their everyday work into a cohesive and satisfying career. While there is substantial turnover in the profession, some WCPs stay in writing center positions for decades. Drawing on information gathered through surveys and interviews with ten long-term WCPs (with an average of 28 years of experience), as well as reflecting on his own career, the …

Composing An Anti-Racism And Social Justice Statement At A Rural Writing Center, Amanda Fields

The Writing Center Journal

This article describes the year-long collaborative composing process of a rural writing center seeking to develop an anti-racism and social justice statement. The author reflects on the way in which rural perspectives are often dismissed, often seen as provincial and hostile towards ideas that might be included in an anti-racism and social justice statement. The piece also connects theories of composing, fluidity, and identity to the writing of the statement and provides a detailed analysis of the lengthy, often challenging composing process used. The author finds that the collaborative composing process, more than the resulting statement, was significant to the …

The Neglected “R”: Replicability, Replication, And Writing Center Research, Susanne Hall, Holly Ryan

The Writing Center Journal

This article makes an argument for the value of both replicable research and replication research in writing center studies. In their discussion of replicability, the authors argue that writing about empirical research so that this research can be replicated will improve the quality of communication in writing center studies whether or not replication studies are subsequently undertaken. The authors further provide for researchers specific guidance on how to create replicable studies, focusing on best practices for describing data sets and sampling, sharing surveys and interview protocols, detailing coding efforts, establishing infrastructure to share data sets, and writing about statistics. Further, …

Nes And Nnes Student Writers’ Very Long Turns In Writing Center Conferences, Jo Mackiewicz, Zach Gasior

The Writing Center Journal

Most tutors are trained in a core writing centers belief: Student writers who talk about their writing are student writers who will achieve better learning outcomes. Our comparative study—one of few in writing center research—examined the points in conferences in which student writers talked the most. We examined the very long turns (VLTs) of eight native English speaking (NES) student writers and eight non-native English speaking (NNES) student writers across 16 writing center conferences. We found that NESs contributed more VLTs than NNESs and that more NES conferences contained VLTs. We also found that stating goals for the conference occurred …

Conceptual Replication And Extension Of The Relation Between The Number Line Estimation Task And Mathematical Competence Across Seven Studies, Alexa Ellis, María Inés Susperreguy, David J. Purpura, Pamela E. Davis-Kean

Purdue Center for Early Learning Faculty and Staff Publications

A recent meta-analysis demonstrated the overall correlation between the number line estimation (NLE) task and children’s mathematical competence was r = .44 (positively recoded), and this relation increased with age. The goal of the current study was to conceptually replicate and extend these results by further synthesizing this correlation utilizing studies not present in the meta-analysis. Across seven studies, 954 participants, ranging from 3 to 11 years old (Age M = 6.02 years, SD = 1.57), the overall estimation-competence correlations were similar to those of the meta-analysis and ranged from r = −.40 to −.35. The current conceptual replication demonstrated …

Catenate: Creating An Interdisciplinary Art Project, Brian Phillips, Melissa Eddings Mancuso, Emma Sherban

Symposium on Education in Entertainment and Engineering

This paper will present the rationale for, the challenges of, and successes encountered in the formation process of an interdisciplinary Visual & Performing Arts Project, Catenate, at Ohio Northern University’s School of Visual & Performing Arts.

“Dusty” Arcadias: Pastoral Visions And Greek Landscape In The Work Of Fred Boissonnas In The Context Of Mediterranean Cultural Myth, Marianna Karali

Artl@s Bulletin

In the following paper, I examine the possible affiliation the Swiss commercial photographer Fred Boissonnas shared with certain groups of Greek-French Nationalists as early as in 1903-1907 and the way this particular nexus inspired the integrity of his work on Greek landscape, forming as well his naturalistic vision on photography. Within the visionary spectrum of a northerner excursionist and the aesthetic eye of a Pictorialist photographer, Boissonnas marked an Innovative gaze upon Mediterranean Arcadian Imagery, altering the Symbolic Classicism of von Gloeden paradigm of Italian South.

Development And Validation Of A Survey Instrument Targeting Teachers’ Perceptions Of The Scope Of Engineering, Jacob Pleasants

Journal of Pre-College Engineering Education Research (J-PEER)

Around the world, pre-college teachers are increasingly being called upon to address engineering, often as part of science instruction. Teachers are typically tasked with engaging students in authentic engineering design activities to promote students’ development of design practices while deepening their knowledge of relevant science concepts. Planning and implementing engineering experiences that authentically reflect the field require that teachers hold accurate perceptions of what engineering is, how it works, and how it is related to yet distinct from science. As teacher education and research efforts in this area grow, there is a need for high-quality instruments that elicit key aspects …

Paroimia: Brusantino, Florio, Sarnelli, And Italian Proverbs From The Sixteenth And Seventeenth Centuries, Daniela D’Eugenio

Purdue Studies in Romance Literatures

Proverbs constitute a rich archive of historical, cultural, and linguistic significance that affect genres and linguistics codes. They circulate through writers, texts, and communities in a process that ultimately results in modifications in their structure and meanings. Hence, context plays a crucial role in defining proverbs as well as in determining their interpretation. Vincenzo Brusantino’s Le cento novella (1554), John Florio’s Firste Fruites (1578) and Second Frutes (1591), and Pompeo Sarnelli’s Posilecheata (1684) offer clear representations of how traditional wisdom and communal knowledge reflect the authors’ personal perspectives on society, culture, and literature. The analysis of the three authors’ proverbs …

Social Pressure, Altruism, Free-Riding, And Non-Compliance In Mask Wearing By U.S. Residents In Response To Covid-19 Pandemic, Courtney Bir, Nicole Olynk Widmar

Department of Agricultural Economics Faculty Publications

Human behavior, such as wearing a mask in public, affects the trajectory of the COVID-19 pandemic. A nationally representative survey of 1198 U.S. residents was used to study demographics, perceptions, and stated beliefs of residents who indicated they believe masks have a role in society in response to COVID-19 but self-reported not wearing masks in at least one public place studied. Individuals who believed wearing masks protected others were more likely to report voluntarily wearing them, providing possible evidence of altruism. Perceiving social pressure negatively impacted the probability of voluntary mask wearing amongst those who believed masks have a role …

Racism, Posttraumatic Stress Symptoms, And Racial Disparity In The U.S. Covid-19 Syndemic, Xiang Zhou, Viann N. Nguyen-Feng, Rachel Wamser-Nanney, Annett Lotzin

Department of Educational Studies Faculty Publications

The COVID-19 syndemic, with a disproportionately higher adverse impact on communities of color (i.e., COVID-19 infection and death), will likely exacerbate the existing health disparities in trauma-related symptoms between people of color (POC) and White Americans. However, no studies have examined the racial disparity in posttraumatic stress symptoms (PTSS) during COVID-19. Grounded in ecological theory and racial trauma framework, we investigated racial disparity in PTSS and three possible mechanisms, 1) COVID stress, 2) direct racism, and 3) indirect racism, for these discrepancies using a large U.S. national sample. Results indicated that POC reported higher levels of PTSS than White Americans. …

A Giant Nlr Gene Confers Broad-Spectrum Resistance To Phytophthora Sojae In Soybean, Weidong Wang, Liyang Chen, Kevin Fengler, Joy Bolar, Victor Llaca, Xutong Wang, Chancelor B. Clark, Tomara J. Fleury, Jon Myrvold, David Oneal, Maria Magdalena Van Dyk, Ashley Hudson, Jesse Munkvold, Andy Baumgarten, Jeff Thompson, Guohong Cai, Oswald Crasta, Rajat Aggarwal, Jianxin Ma

Purdue University Libraries Open Access Publishing Fund

Phytophthora root and stem rot caused by P. sojae is a destructive soybean soil-borne disease found worldwide. Discovery of genes conferring broad-spectrum resistance to the pathogen is a need to prevent the outbreak of the disease. Here, we show that soybean Rps11 is a 27.7-kb nucleotide-binding site-leucine-rich repeat (NBS-LRR or NLR) gene conferring broad-spectrum resistance to the pathogen. Rps11 is located in a genomic region harboring a cluster of large NLR genes of a single origin in soybean, and is derived from rounds of unequal recombination. Such events result in promoter fusion and LRR expansion that may contribute to the …

Joint Medicines Regulatory Procedure In The East African Community: Registration Timelines And Way Forward, Jane Mashingia, S Maboko, P I. Mbwiri, A Okello, S I. Ahmada, R Barayandema, R Tulba, E Byomuhangi, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review the dossier was 391 days and the minimum time …

Herbal Medicines Registration Process For Zimbabwe Overview Of The Process, Jannet Usai, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

Unregistered traditional medicines pose a huge public health threat as the safety and efficacy of these products is unknown. The issue this study addresses is the inadequate regulatory measures for herbal medicines in Zimbabwe. This project was done to describe the current registration process of traditional medicines in Zimbabwe, and to identify the gaps and opportunities they present to improve the regulatory landscape. Regulations and laws governing the registration of herbal medicines in the country and published research on legislation of herbal medicines were reviewed. Two parallel regulatory bodies both registering and controlling the sale of herbal medicines were identified. …

Knowledge Sharing In Organisations: Finding A Best-Fit Model For A Regulatory Authority In East Africa, Padde Musa, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

Knowledge is an essential organisational asset that contributes to organisational effectiveness when carefully managed. Knowledge sharing (KS) is a vital component of knowledge management that allows individuals to engage in new knowledge creation. Until it’s shared, knowledge is considered useless since it resides within the human brain. Public organisations specifically, are more involved in providing and developing knowledge and hence can be classified as knowledge-intensive organisations. Scholarly research conducted on KS has proposed a number of models to help understand the KS process between individuals but none of these models is specifically for a public organisation. Moreover, to really reap …

Improving The Outcome Of Gmp Inspections By Improving Proficiency Of Inspectors Through Consistent Gmp Trainings, Solomon Shiihi, U G. Okafor, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by the specification of the product. Inspection reports on …

Compliance To Gmp Guidelines For Herbal Manufacturers In East Africa: A Position Paper, Victoria Kwesiga, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence …

Evaluating And Understanding The Reason For An Increase In Nonconformances In The Laboratory, Andrew Mukungu, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

This is a study of nonconformances experienced by a laboratory of a pharmaceutical manufacturing facility in East Africa. There has been an increase in nonconformances from 216 nonconformances in 2017 to 229 in 2018 and by September 2019, 306 nonconformances were already logged. Increasing nonconformances result in delayed release of tested materials and many resources are wasted (e.g. chemicals, man hours and equipment). Analysts become frustrated, which may result in inexhaustive investigations. Understanding the reason for the increase in nonconformances will enable the facility to derive effective solutions to the identified causes, hence reducing the number of nonconformances and improving …

Standardisation Of Staff Training To Increase Efficiency, Kikundwa Emma Mbabazi, Z Ekeocha, S Byrn, K Clase

BIRS Africa Technical Report Papers

In any industry or organization, personnel training is emphasized with reference to National Regulatory Authorities (NRAs) guidelines and other globally accepted guidelines. In spite of many refresher training programs, the pharmaceutical industry still faces significant variations in individual/ team efficiency and productivity. Individuals/teams given the same task, SOPs, environment and materials continue to produce significantly different results reflecting the possibility of operating on different sets of theoretical and practical information, which may stem from differing trainer, training program or training method. This study focused on using a standardized manual for training two teams A and B involved in vaccine production, …

Research Experiences Instrument: Validation Evidence For An Instrument To Assess The Research Experiences Of Engineering Ph.D. Students’ Professional Practice Opportunities, Eric A. Holloway, Kerrie A. Douglas, David F. Radcliffe, William C. Oakes

School of Mechanical Engineering Faculty Publications

Background. There are long-held concerns about how graduate research programs prepare engineering Ph.D. students for professional practice. Suitable instruments are lacking to effectively assess how research experiences contribute to the success of graduate students becoming professionals.

Purpose. The purpose of this work is to examine evidence of internal reliability and validity of using the Research Experiences Instrument (REI) scores as a measure of engineering Ph.D. students’ professional practice opportunities in their research experiences.

Method. REI was constructed using an ontological framework. REI was administered twice to engineering Ph.D. students, once to a single university (n = 236) and …

Dewey, Hippie Communes, And Education, Luis S. Villacañas De Castro

Education and Culture

In this article I aim to establish a relevant connection between John Dewey’s educational philosophy and the hippie communes of the United States during the nineteen sixties and seventies. After an assessment of Dewey’s philosophy against the background of the countercultural sixties, I summarize and organize Dewey’s philosophical thought around the concepts of growth, experience, education, democracy, and occupations. I then look closely at seven memoirs describing life in five different hippie communes, and draw on them to present illustrations of the main tenets of Dewey’s educational philosophy and of its contemporary significance.

From Widgets To Wizards: Pedagogy For The Scoreboard Society, Bob Coulter

Education and Culture

Many schools today are driven by metrics intended to quantify student achievement, ostensibly in the interest of ensuring quality and accountability in public schools. In practice, this emphasis on performance over experience narrows schools’ potential to foster student growth toward democratic citizenship. This article offers a constructive alternative that fuses classical pragmatic foundations with emerging research in extended cognition, neuroplasticity, and epigenetics.

Data Without Democracy: The Cruel Optimism Of Education Technology And Assessment, Mark D. Tschaepe

Education and Culture

This essay examines contemporary digital educational assessment and argues that there are underlying problematic values and consequences entailed by the datafication of education as coupled with assessment practices. By applying Dewey’s work concerning curriculum, aims, growth, and the conception of democracy through education to current methods, this examination exposes digital assessment as perpetuating a cruel optimism through assessment that undermines democratic, progressive functions of education. Dewey’s philosophy provides a perspective from which to repurpose digital tools in a manner that fosters, rather than hinders, aims, growth, and democracy in education.