Medical Device Quality Assurance and Regulatory Compliance, Fries, Richard C.
Автор: Fay A. Rozovsky JD, MPH Название: Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance ISBN: 0787965707 ISBN-13(EAN): 9780787965709 Издательство: Wiley Рейтинг: Цена: 148840.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a range of topics, such as consent, confidentiality, subject recruitment and selection, and Institutional Review Board, this book offers useful strategies for achieving regulatory compliance while reducing liability.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1461469155 ISBN-13(EAN): 9781461469155 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today`s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing.
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.
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: 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: White William Название: Excellence Beyond Compliance ISBN: 1138491470 ISBN-13(EAN): 9781138491472 Издательство: Taylor&Francis Рейтинг: Цена: 44910.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.
This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.
After a review of the challenges that any medical device company faces in the world of today--the multiple sources of QMS requirements--the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.
This book offers:
Advice that will lead to an effective and efficient QMS.
Detailed guidance on the key decisions to be made regarding the quality system being established.
Detailed ideas on how to execute those decisions.
Up-to-date information on compliance to current regulations and standards and guidance on staying up to date.
Specific examples of procedures.
Information regarding requirements for combination products, such as a drug + device combination.
Advice on incorporating risk management in the QMS.
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: 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: Walters, S. J. Название: Quality of Life Outcomes in Clinical Trials and Health-Care ISBN: 047075382X ISBN-13(EAN): 9780470753828 Издательство: Wiley Рейтинг: Цена: 77030.00 T Наличие на складе: Поставка под заказ. Описание: An essential, up-to-date guide to the design of studies and selection of the correct QoL instruments for observational studies and clinical trials. Quality of Life (QoL) outcomes or Person/Patient Reported Outcome Measures (PROMs) are now frequently being used in randomised controlled trials (RCTs) and observational studies.
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