A 3D-bioprinting exemplar of the consequences of the regulatory requirements on customised processes

Computer-aided three-dimensional (3D) printing approaches to the industrial production of customised 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customised, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and US regulatory frameworks do not account for the differences between 3D-printing and conventional manufacturing methods or the ability to create individual customised products using mechanised rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products

Justification for Class 3 Permit Modification, Corrective Action Complete with Controls, Solid Waste Management Unit 76, Mixed Waste Landfill, Sandia National Laboratories/New Mexico, EPA ID Number NM5890110518 Volumes I through VIII

The Department of Energy/National Nuclear Security Administration (DOE) and Sandia Corporation (Sandia) are submitting a request for a Class 3 Modification to Module IV of Hazardous Waste Permit NM5890110518-1 (the Permit). DOE and Sandia are requesting that the New Mexico Environment Department (NMED) designate solid waste management unit (SWMU) 76 as approved for Corrective Action Complete status. NMED made a preliminary determination in October 2014 that corrective action is complete at this SWMU. SWMU 76, known as the Mixed Waste Landfill (MWL), is a 2.6-acre site at Sandia National Laboratories, located on Kirtland Air Force Base immediately southeast of Albuquerque, New Mexico. Radioactive wastes and mixed wastes (radioactive wastes that are also hazardous wastes) were disposed of in the MWL from March 1959 through December 1988. The meximum depth of burial is approximately 25 feet below the ground surface. Groundwater occurs approximately 500 feet below the ground surface at the MWL. DOE and Sandia have implemented corrective measures at SWMU 76 in accordance with the requirements of the Permit; an April 2004 Compliance Order on Consent between NMED, DOE, and Sandia; and the plans approved by NMED. On January 8, 2014, NMED approved a long-term monitoring and maintenance plan (LTMMP) for SWMU 76. DOE and Sandia have implemented the approved LTMMP, maintaining the controls established through the corrective measures. The permit modification request consists of a letter with two enclosures: 1. A brief history or corrective action at SWMU 76 2. An index of the supporting documents that comprise the justification for the permit modification request. The supporting documents are included in an 8-volume set: Justification for Class 3 Permit Modification for Corrective Action Complete With Controls, Solid Waste Management Unit 76, Mixed Waste Landfill. Volume/pages: I/858. II/420. III/556. IV/1128. V/848. VI/1110. VII/914. VIII/866

Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries

This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are better protected since the publication of ICH Q9, a commonly employed guidance on the application of QRM; second, to characterize the industry with regard to QRM maturity, including the effectiveness of QRM application, the behaviors, attitudes, and motivations of the people working with and within QRM, and the governance and oversight of QRM efforts; and third, to construct a mature QRM program and associated maturity measurement tool to accelerate improvements in QRM and better protect the patient. The research employed a mixed methods approach, including the research methods of literature review, philosophical dialogues, benchmarking survey, semi-structured interview, and pilot case studies. The research concluded that the patient is no better protected since the inception of QRM and the level of QRM maturity throughout the pharmaceutical and biopharmaceutical industries remains rather low. However, the research also indicated that progression towards the more mature QRM model proposed in thesis may help firms perform QRM in a more effective manner, resulting in improved management of risk to the patient

Transforming Lives at Sheridan : a Tribute to Dr. Mozammel Khan

The original 2017 edition of this title was published in recognition of Dr. Mozammel Khan’s career in quality assurance instruction and positive impact on graduates of Sheridan College’s Quality Assurance Manfacturing Management program (PQUAS), with proceeds from the book supporting the Mozammel Khan scholarship Foundation. Khan, originally from Bangladesh, taught in Singapore before immigrating to Canada in the 1990s, where he founded the first post-secondary QA program of its kind in Ontario at Sheridan College. Editor Lorraine Fraser collects heartfelt letters of appreciation to Khan from alumni of the PQUAS program, who share memories, successes and challenges from their time as students at Sheridan, as well as describing his impact on their careers in the field. In an autobiographical chapter, Khan shares his background in engineering and quality assurance, his journey as an immigrant, and his involvement in developing Sheridan’s PQUAS program. Dr. Iain McNab (Dean of Faculty of Applied Science and Technology) further discusses Khan’s personal history and career at Sheridan in an interview, while his political life and impact for other new immigrants are explored by Professor Jack Urowitz (Faculty of Animation, Art and Design) and Dr. Soumitra Nandi (Faculty of Applied Science and Technology).https://source.sheridancollege.ca/fast_books/1004/thumbnail.jp

The management of risk and investment in cell therapy process development: a case study for neurodegenerative disease

Cell-based therapies must achieve clinical efficacy and safety with reproducible and cost-effective manufacturing. This study addresses process development issues using the exemplar of a human pluripotent stem cell-based dopaminergic neuron cell therapy product. Early identification and correction of risks to product safety and the manufacturing process reduces the expensive and time-consuming bridging studies later in development. A New Product Introduction map was used to determine the developmental requirements specific to the product. Systematic Risk Analysis is exemplified here. Expected current valuebased prioritization guides decisions about the sequence of process studies and whether and if an early abandonment of further research is appropriate. The application of the three tools enabled prioritization of the development studie

Establishing a formulation design space for a generic clobetasol 17- propionate cream using the principles of quality by design

The pharmaceutical industry is global, is highly regulated and is able to achieve reasonable product quality but at high cost with maximum effort. Numerous challenges face the pharmaceutical industry and include a shrinking research pipeline, less innovation, outsourcing, investments, increasing research and development costs, long approval times, growth of the generic industry, failure to understand or analyze manufacturing failure and wastage as high at fifty percent for some pharmaceutical products. An efficient and flexible pharmaceutical sector should be able to consistently produce high quality pharmaceutical products at a reduced cost with minimal waste. As a result, Food and Drug Administration (FDA) and other agencies such as the International Conference on Harmonization (ICH) have embraced a “Quality by Design” (QbD) paradigm and this has become the “desired state” so as to shift manufacturing from being empirical to a science, engineering, and risk based approach. QbD is a systematic approach for the development of high quality pharmaceutical dosage forms that begins with predefined objectives based on the premise that quality must be built into and not tested into a product. QbD together with the establishment of a design space for dosage forms is a fairly new concept and there is limited published data on QbD concepts that report the entire process of identifying Critical Quality Attributes (CQA), design of a formulation and manufacturing process to meet product CQA, understanding the impact of material attributes and process parameters on product CQA, identification and controlling sources of variability in materials and processes that affect the CQA of a product and finally establishing, evaluating and testing a design space using both in vitro and in vivo approaches to assure that a product of consistent quality can always be produced. The objective of these studies was to implement a QbD approach to establish a design space for the development and manufacture of a safe, effective, stable generic formulation containing 0.05% w/w clobetasol 17-propionate (CP) that had similar in vitro and in vivo characteristics to an innovator product, Dermovate® (Sekpharma® Pty Ltd, Sandton, Gauteng, RSA). Such a product would pose a minimal risk of failure when treating severe skin disorders such as seborrhoeic dermatitis, extreme photodermatitis and/or severe psoriasis in HIV/AIDS patients in Southern Africa

The Influence of Nursing Home Administrator Turnover on Resident Quality of Life

By 2040, 79.7 million older adults will live in the US, and nearly 40% will need nursing home services that are primarily funded by Medicare and Medicaid. Researchers have underscored the importance of leadership in quality healthcare care delivery, suggesting that nursing home administrator turnover could influence resident quality of life, causing ill-health for the residents and preventable medical costs for taxpayers. In spite of the suggested association, little research has specifically examined the role of administrator turnover on resident quality of life. As such, the purpose and central research questions of this case study were designed specifically to address the relationship between nursing home administrator turnover and resident quality of life. The Donabedian health services quality model was the framework for the study. Data were collected from 14 nursing homes, and included semistructured interview data with 7 nursing home administrators, and a review of other documents related to quality of care including site visit reports and surveys. An iterative process of coding and constant comparison was used to identify themes and categories from the data. The findings indicate that turnover likely caused an adverse impact on the nursing home overall, which was expected. The study also determined, however, that high turnover itself was not perceived to be associated to low resident quality of life. The implication for social change is that nursing home stakeholders may develop processes to retain competent administrators which in turn could reduce absent leadership presence in nursing homes. Consistent leadership presence may lead to improvement in quality of life regulatory compliance and reduction in unnecessary Medicare and Medicaid spending by nursing home residents

Utilização de dados estruturados na resposta a perguntas relacionadas com saúde

The current standard way of searching for information is through the usage of some kind of search engine. Even though there has been progress, it still is mainly based on the retrieval of a list of documents in which the words you searched for appear. Since the users goal is to find an answer to a question, having to look through multiple documents hoping that one of them have the information they are looking for is not very efficient. The aim of this thesis is to improve that process of searching for information, in this case of medical knowledge in two different ways, the first one is replacing the usual keywords used in search engines for something that is more natural to humans, a question in its natural form. The second one is to make use of the additional information that is present in a question format to provide the user an answer for that same question instead of a list of documents where those keywords are present. Since social media are the place where people replace the queries used on a search engine for questions that are usually answered by humans, it seems the natural place to look for the questions that we aim to provide with automatic answers. The first step to provide an answer to those questions will be to classify them in order to find what kind of information should be present in its answer. The second step is to identify the keywords that would be present if this was to be searched through the currently standard way. Having the keywords identified and knowing what kind of information the question aims to retrieve, it is now possible to map it into a query format and retrieve the information needed to provide an answer.Atualmente a forma mais comum de procurar informação é através da utilização de um motor de busca. Apesar de haver progresso os seus resultados continuam a ser maioritariamente baseados na devolução de uma lista de documentos onde estão presentes as palavras utilizadas na pesquisa, tendo o utilizador posteriormente que percorrer um conjunto dos documentos apresentados na esperança de obter a informação que procura. Para além de ser uma forma menos natural de procurar informação também é menos eficiente. O objetivo para esta tese é melhorar esse processo de procura de informação, sendo neste caso o foco a área da saúde. Estas melhorias aconteceriam de duas formas diferentes, sendo a primeira a substituição da query normalmente utilizada em motores de busca, por algo que nos é mais natural - uma pergunta. E a segunda seria aproveitar a informação adicional a que temos acesso apenas no formato de pergunta, para fornecer os dados necessários à sua resposta em vez de uma lista de documentos onde um conjunto de palavras-chave estão presentes. Sendo as redes sociais o local onde a busca por informação acontece através da utilização de perguntas, em substituição do que seria normal num motor de busca, pelo facto de a resposta nestas plataformas ser normalmente respondida por humanos e não máquinas. Parece assim ser o local natural para a recolha de perguntas para as quais temos o objetivo de fornecer uma ferramenta para a obtenção automática de uma resposta. O primeiro passo para ser possível fornecer esta resposta será a classificação das perguntas em diferentes tipos, tornando assim possível identificar qual a informação que se pretende obter. O segundo passo será identificar e categorizar as palavras de contexto biomédico presentes no texto fornecido, que seriam aquelas utilizadas caso a procura estivesse a ser feita utilizando as ferramentas convencionais. Tendo as palavras-chave sido identificadas e sabendo qual o tipo de informação que deverá estar presente na sua resposta. É agora possível mapear esta informação para um formato conhecido pelos computadores (query) e assim obter a informação pretendida.Mestrado em Engenharia Informátic

The Essential role of laboratory professionals : ensuring the safety and effectiveness of laboratory data in electronic health record systems

The development of electronic health record (EHR) systems and other health information technologies is changing how laboratory data are transmitted and displayed throughout the healthcare system. The purpose of this paper is to provide an overview of the key areas in which laboratory professionals can contribute their expertise to the development of accurate exchange and display of laboratory data in EHR systems. Thoughtfully designed and rigorously tested EHR systems improve patient care by making it easier to collect, share, and interpret patient data. However, variations in EHR system design, functionality, and ability to exchange data accurately (interoperability) can also cause preventable patient safety risks. Examples of preventable patient safety risks include misdiagnosis, delays in treatment, and inappropriate treatment. These patient safety risks may unintentionally result in patient injury or even death. For the purpose of this paper, an EHR is safe and effective for laboratory data when the display of information and the computer system\ue2\u20ac\u2122s behaviors (such as critical result alerts) are developed and implemented to optimally ensure accurate and timely interpretation by the end user.The purpose of this paper is to illustrate the seriousness of laboratory data-related interoperability issues and display discrepancies in EHR systems, and propose focus areas for action by laboratory professionals to support resolving those issues. Through collaboration, laboratory professionals, clinicians, healthcare executives, medical professional societies, health IT developers, and federal agencies like the Office of the National Coordinator for Health Information Technology (ONC), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA), can work together to develop effective solutions to reduce identified patient safety risks in and improve the safety of EHR systems.Suggested citation: Sawchuk, M., Linville, M., Cornish, N., Pollock, A., Lubin, I., Gagnon, M., and Stinn, J. The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems. Atlanta, GA: Center for Surveillance, Epidemiology and Laboratory Services, Centers for Disease Control and Prevention; May 2014. Retrieved from http://www.cdc.gov/labhit/paper/Laboratory_Data_in_EHRs_2014.pdfCS245536-ALaboratory_Data_in_EHRs_2014.pd

AI in Learning: Designing the Future

AI (Artificial Intelligence) is predicted to radically change teaching and learning in both schools and industry causing radical disruption of work. AI can support well-being initiatives and lifelong learning but educational institutions and companies need to take the changing technology into account. Moving towards AI supported by digital tools requires a dramatic shift in the concept of learning, expertise and the businesses built off of it. Based on the latest research on AI and how it is changing learning and education, this book will focus on the enormous opportunities to expand educational settings with AI for learning in and beyond the traditional classroom. This open access book also introduces ethical challenges related to learning and education, while connecting human learning and machine learning. This book will be of use to a variety of readers, including researchers, AI users, companies and policy makers