Requirements For Blood And Blood Components Intended For Transfusion Or For Further Manufacturing Use Us Food And Drug Administration Regulation Fda 2018 Edition
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Author |
: Paula R. Howard |
Publisher |
: Elsevier Health Sciences |
Total Pages |
: 434 |
Release |
: 2020-07-16 |
ISBN-10 |
: 9780323697408 |
ISBN-13 |
: 0323697402 |
Rating |
: 4/5 (08 Downloads) |
Synopsis Basic & Applied Concepts of Blood Banking and Transfusion Practices - E-Book by : Paula R. Howard
Make complex blood banking concepts easier to understand with Basic & Applied Concepts of Blood Banking and Transfusion Practices, 5th Edition. Combining the latest information in a highly digestible format, this approachable text helps you easily master all areas of blood banking by utilizing common theory, clinical scenarios, case studies, and critical-thinking exercises. With robust user resources and expanded content on disease testing and DNA, it's the effective learning resource you need to successfully work in the modern lab. - Coverage of advanced topics such as transplantation and cellular therapy, the HLA system, molecular techniques and applications, automation, electronic cross-matching, and therapeutic apheresis make the text more relevant for 4-year MLS/CLS programs. - Illustrated blood group boxes provide the ISBT symbol, number, and clinical significance of antibodies at a glance. - Robust chapter pedagogy helps break down this difficult subject with learning objectives, outlines, key terms with definitions, chapter summaries, critical thinking exercises, study questions, and case studies. - NEW! Completely updated content prepares you to work in today's clinical lab environment. - NEW! Additional information on disease testing covers diseases such as Zika and others of increased importance. - NEW! Expanded content on DNA covers the latest developments in related testing. - NEW! Enhanced user resources on the Evolve companion website now include expanded case studies, and new animations in addition to the existing review questions and lab manual.
Author |
: Caludia S. Cohn |
Publisher |
: |
Total Pages |
: 816 |
Release |
: 2020 |
ISBN-10 |
: 1563953706 |
ISBN-13 |
: 9781563953705 |
Rating |
: 4/5 (06 Downloads) |
Synopsis Technical Manual by : Caludia S. Cohn
Author |
: Council of Europe |
Publisher |
: Manhattan Publishing Company |
Total Pages |
: 184 |
Release |
: 1997 |
ISBN-10 |
: MINN:31951P00568218D |
ISBN-13 |
: |
Rating |
: 4/5 (8D Downloads) |
Synopsis Guide to the Preparation, Use and Quality Assurance of Blood Components by : Council of Europe
Author |
: Office of The Federal Register |
Publisher |
: IntraWEB, LLC and Claitor's Law Publishing |
Total Pages |
: 256 |
Release |
: 2018-04-01 |
ISBN-10 |
: 9781640243125 |
ISBN-13 |
: 1640243127 |
Rating |
: 4/5 (25 Downloads) |
Synopsis 2018 CFR Annual Print Title 21 Food and Drugs Parts 200 to 299 by : Office of The Federal Register
Author |
: Mark Walderhaug |
Publisher |
: Createspace Independent Publishing Platform |
Total Pages |
: 292 |
Release |
: 2014-01-14 |
ISBN-10 |
: 1495203611 |
ISBN-13 |
: 9781495203619 |
Rating |
: 4/5 (11 Downloads) |
Synopsis Bad Bug Book by : Mark Walderhaug
The Bad Bug Book 2nd Edition, released in 2012, provides current information about the major known agents that cause foodborne illness.Each chapter in this book is about a pathogen—a bacterium, virus, or parasite—or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses.A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference.The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services.
Author |
: Hua Shan |
Publisher |
: Springer |
Total Pages |
: 0 |
Release |
: 2019-02-14 |
ISBN-10 |
: 303006851X |
ISBN-13 |
: 9783030068516 |
Rating |
: 4/5 (1X Downloads) |
Synopsis Blood Safety by : Hua Shan
This book offers a concise yet comprehensive overview on critical issues in monitoring and responding to new microbial threats to blood safety. It provides information on the current concerns and mechanisms for monitoring potential new infectious threats to blood safety, evaluates the response to these new threats, and explores the complex issues related to blood safety, including health economics, the relationship between levels of public health threats (actual danger) versus public concerns (perceived danger), and the challenges in coordinating international collaborative efforts. The text also includes several case studies that illustrate the existing systems used for monitoring and responding to new threats to blood safety. Written by experts in the field, Blood Safety: A Guide to Monitoring and Responding to Potential New Threats is a valuable resource for health care professionals who are responsible for the medical management of blood services.
Author |
: Philip C. Spinella |
Publisher |
: Springer |
Total Pages |
: 379 |
Release |
: 2019-08-12 |
ISBN-10 |
: 9783030208202 |
ISBN-13 |
: 3030208206 |
Rating |
: 4/5 (02 Downloads) |
Synopsis Damage Control Resuscitation by : Philip C. Spinella
This book provides a comprehensive overview of damage control resuscitation (DCR), an evidence-based approach to the resuscitation of patients with severe life-threatening hemorrhage (LTH). It focuses on both civilian and military applications as DCR is utilized in civilian trauma situations as well as combat casualty care settings. The book covers the history of fluid resuscitation for bleeding, epidemiology of severe traumatic injuries, prediction of life-threatening hemorrhage, pathophysiology and diagnosis of blood failure, and permissive hypotension. Chapters provide in-depth detail on hemostatic resuscitation principles, dried plasma, dried platelet surrogates, and recent developments in frozen red blood cells and oxygen carriers. The book also discusses how DCR principles can be used in a variety of situations such as when there are large numbers of patients with hemorrhagic lesions, non-trauma scenarios, and on distinct populations such as children. Finally, it concludes with a discussion of training and education methods for the implementation of DCR and remote DCR principles as well as learning healthcare system principles to facilitate the implementation of DCR and ultimately improve outcomes for patients with life-threatening hemorrhage. Damage Control Resuscitation: Identification and Treatment of Life-Threatening Hemorrhage is an essential resource for physicians and related professionals, residents, nurses and medical students in emergency medicine, anesthesia, surgery, and critical care, as well as civilian and military EMS providers.
Author |
: United States Food and Drug Administration |
Publisher |
: Createspace Independent Publishing Platform |
Total Pages |
: 92 |
Release |
: 2017-09-21 |
ISBN-10 |
: 1976578671 |
ISBN-13 |
: 9781976578670 |
Rating |
: 4/5 (71 Downloads) |
Synopsis Pharmaceutical Microbiology Manual by : United States Food and Drug Administration
Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Author |
: Agency for Healthcare Research and Quality/AHRQ |
Publisher |
: Government Printing Office |
Total Pages |
: 385 |
Release |
: 2014-04-01 |
ISBN-10 |
: 9781587634338 |
ISBN-13 |
: 1587634333 |
Rating |
: 4/5 (38 Downloads) |
Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author |
: World Health Organization |
Publisher |
: |
Total Pages |
: 0 |
Release |
: 2013 |
ISBN-10 |
: 9241548517 |
ISBN-13 |
: 9789241548519 |
Rating |
: 4/5 (17 Downloads) |
Synopsis Blood Donor Selection by : World Health Organization
The WHO guidelines on assessing donor suitability for blood donation have been developed to assist blood transfusion services in countries that are establishing or strengthening national systems for the selection of blood donors. They are designed for use by policy makers in national blood programmes in ministries of health, national advisory bodies such as national blood commissions or councils, and blood transfusion services.