Pre-Production Quality Assurance for Healthcare Manufacturers PDF Download
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Author: G. William Hough
Publisher: CRC Press
ISBN: 9781574910452
Category : Medical
Languages : en
Pages : 296
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Book Description
The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.
Author: G. William Hough
Publisher: CRC Press
ISBN: 9781574910452
Category : Medical
Languages : en
Pages : 296
Get Book Here
Book Description
The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 104
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Book Description
Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420065599
Category : Medical
Languages : en
Pages : 212
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Book Description
The effective and interrelated functioning of system reliability technology, human factors, and quality play an important role in the appropriate, efficient, and cost-effective delivery of health care. Simply put, it can save you time, money, and more importantly, lives. Over the years a large number of journal and conference proceedings articles o
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 18
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Book Description
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 872
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Book Description
Author: Norman F. Estrin
Publisher: CRC Press
ISBN: 9780824782689
Category : Medical
Languages : en
Pages : 1020
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Book Description
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Author: Richard J. Arend
Publisher: Springer Nature
ISBN: 303148553X
Category : Business & Economics
Languages : en
Pages : 466
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Book Description
Knight (1921) defines uncertainty as an informational market failure that, while being detrimental to most existing businesses, presents possible profitable opportunities for others. This book builds upon that classic work by providing an analysis of the alternative approaches to strategic decision-making under such uncertainty. It covers what uncertainty is, why it is important, and what connections it has to business and related fields, culminating in a new and comprehensive typology and a valuable guide for how to appropriately address various types of uncertainties, even under AI. It clarifies the current terminological and categorical confusion about ‘unknowns’ while complementing the mathematical, probability-based approaches that treat uncertainty as ‘knowable’ (i.e., as risk). It corrects the mistaken approaches that treat ‘unknowables’ as ‘shapeable’ or ‘discoverable’. This book widens the perspective for viewing uncertainty, in terms of its impacts across humanity, by offering a shrewder understanding of what roles uncertainties play in human activity. It will appeal to academics across business, economics, philosophy, and other disciplines looking for approaches to apply, test, and hone for dealing with decision-making under uncertainty.
Author: Carrillo-Cedillo, Eugenia Gabriela
Publisher: IGI Global
ISBN: 1799896153
Category : Technology & Engineering
Languages : en
Pages : 298
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Book Description
Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
Author: John Sharp
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 536
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Book Description
This overview of quality assurance in pharmaceutical production describes the principles and practice, and discusses specific quality issues, providing a guide to both national and internatinal regulatory requirements.
Author: Thomas A. Barber
Publisher: CRC Press
ISBN: 1000065111
Category : Medical
Languages : en
Pages : 579
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Book Description
Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. He brings together information from over 100 Web sites and other sources and casts it into a practical framework that will help readers ensure their company's success. The book contains thirty-two color photomicrographs and over eighty figures, tables, and charts.
