Medical Device Quality Assurance and Regulatory Compliance, Fries, Richard C.
Автор: Fries, Richard C. Название: Medical Device Quality Assurance and Regulatory Compliance ISBN: 0367400367 ISBN-13(EAN): 9780367400361 Издательство: Taylor&Francis Рейтинг: Цена: 67360.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: "Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Автор: Haider, Syed Imtiaz Название: Validation Standard Operating Procedures ISBN: 0849395291 ISBN-13(EAN): 9780849395291 Издательство: Taylor&Francis Рейтинг: Цена: 265410.00 T Наличие на складе: Нет в наличии.
Complexity of Biologics CMC Regulation.- Biopharmaceutics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Biopharmaceutical Source Materials.- Manufacturing of Biopharmaceutical APIs.- Manufacturing of the Drug Product.- Complex Process-Related Impurity Profiles.- Product Characterization is a Journey.- Priceless Potency (Therapeutic Activity).- Quality Attributes of a Biopharmaceutical.- Designing the Stability Program.- The Art of Setting Specifications.- Demonstrating Product Comparability After Process Changes.- Invaluable CMC-Focused Meetings with Regulatory Authorities.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1493943995 ISBN-13(EAN): 9781493943999 Издательство: Springer Рейтинг: Цена: 149060.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In its new edition, this book reviews the challenges facing quality assurance and control (QA/QC) in today`s biopharmaceutical environment, putting into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
Автор: Saluja/ Singal Название: Standard Operating Procedures & Regulatory Guidelines Blood Banking ISBN: 9351522156 ISBN-13(EAN): 9789351522157 Издательство: JayPee Brothers India Рейтинг: Цена: 34270.00 T Наличие на складе: Нет в наличии. Описание: Provides blood bank technicians, students undergoing various courses in medical technology, and residents with a concise and thorough practical and simple procedural guide to all the procedures to check the quality and safety of the blood donated for transfusion.
Автор: Parag Kolhe; Mrinal Shah; Nitin Rathore Название: Sterile Product Development ISBN: 1461479770 ISBN-13(EAN): 9781461479772 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book addresses key concepts and applications in sterile product development. Throughout, it illustrates key concepts relevant to the successful development of sterile products with the help of case studies.
Автор: Fiedler, Beth Ann Название: Managing Medical Devices within a Regulatory Framework ISBN: 012804179X ISBN-13(EAN): 9780128041796 Издательство: Elsevier Science Рейтинг: Цена: 131380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle.
This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.
Автор: Bernd W. Wenclawiak; Michael Koch; Evsevios Hadjic Название: Quality Assurance in Analytical Chemistry ISBN: 3642448518 ISBN-13(EAN): 9783642448515 Издательство: Springer Рейтинг: Цена: 60940.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In this revised and enlarged textbook, the authors provide an in-depth but easy to understand coverage of quality assurance for chemical measurements. In particular the chapters on measurement uncertainty, calibration and validation are practically all new.
Автор: Ute Resch-Genger Название: Standardization and Quality Assurance in Fluorescence Measurements II ISBN: 3540705708 ISBN-13(EAN): 9783540705703 Издательство: Springer Рейтинг: Цена: 200260.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book highlights for the first time the present state of quality assurance and the need for establishing standards in fluorescence measurements. This second of two volumes covers applications of fluorescence for bioanalysis and biomedical diagnostics.
Автор: Pietro Gentile Название: Alopecia: Risk Factors, Treatment and Impact on Quality of Life ISBN: 1536170089 ISBN-13(EAN): 9781536170085 Издательство: Nova Science Рейтинг: Цена: 89750.00 T Наличие на складе: Невозможна поставка. Описание: Centuries ago, predicting was an enterprise entrusted to magic and fortune tellers, while today it is the domain of knowledge to which researchers and scientists contribute daily, analyzing and interpreting pathologies, trying to decode the complexity of life, represented by unresolved problems. Regenerating damaged organs and tissues, an act that was also once called magic, is now entrusted to the same scientists and translational surgeons who, through the entrance of the laboratory in the operating room, have allowed us to move from replacement surgery (hair transplant) to regenerative surgery (hair re-growth) with cell therapies and tissue engineering. The passion for Regenerative Plastic Surgery and for the treatment of some pathologies addressed by it, such as Alopecia, has led, over the years, the author and publisher Prof. Pietro Gentile to better investigate, through rigorous scientific studies, the possible new autologous therapies in the treatment of alopecia. This book represents all the latest knowledge in the treatment and prevention of Alopecia, transmitted by all the experts who have decided to contribute to the realization of this work. The visionary idea of this text is therefore to provide the state of the art at the end of the year 2019 in the field of Alopecia.
Автор: Jeremie M. Gras Название: Laboratory quality control and patient safety ISBN: 3110346176 ISBN-13(EAN): 9783110346176 Издательство: Walter de Gruyter Цена: 43330.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Every clinical laboratory devotes considerable resources to Quality Control. Recently, the advent of concepts such as Analytical Goals, Biological Variation, Six Sigma and Risk Management has generated a renewed interest in the way to perform QC.However, laboratory QC practices remain highly non-standardized and a lot of QC questions are left unanswered. The objective of this book is to propose a roadmap for the application of an integrated QC protocol that ensures the safety of patient results in the everyday lab routine.
Автор: Walter G. Guder Название: Pre-Examination Procedures in Laboratory Diagnostics: Preanalytical Aspects and their Impact on the Quality of Medical Laboratory Results ISBN: 3110331659 ISBN-13(EAN): 9783110331653 Издательство: Walter de Gruyter Цена: 123910.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Die Aussagekraft eines Laborbefundes hängt entscheidend von der Präanalytik ab, also von Prozessen, die vor der eigentlichen Messung der Proben im Labor ablaufen. Dieses Buch beschreibt alle präanalytischen Variablen - Indikation der Anforderung über Probengewinnung, Transport und Lagerung der Proben und Vorverarbeitung dieser für die Analyse - und definiert Qualitätskriterien der einzelnen Aspekte im Sinne einer evidenz-basierten Medizin.
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