Pre-Production Quality Assurance for Healthcare Manufacturers

Pre-Production Quality Assurance for Healthcare Manufacturers

Author: G. William Hough

Publisher: CRC Press

Published: 1997-06-30

Total Pages: 296

ISBN-13: 9781574910452

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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.


Reliability Technology, Human Error, and Quality in Health Care

Reliability Technology, Human Error, and Quality in Health Care

Author: B.S. Dhillon

Publisher: CRC Press

Published: 2008-02-21

Total Pages: 212

ISBN-13: 1420065599

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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


The Medical Device Industry

The Medical Device Industry

Author: Norman F. Estrin

Publisher: CRC Press

Published: 1990-08-31

Total Pages: 1020

ISBN-13: 9780824782689

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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


Uncertainty in Strategic Decision Making

Uncertainty in Strategic Decision Making

Author: Richard J. Arend

Publisher: Springer Nature

Published: 2024-01-03

Total Pages: 466

ISBN-13: 303148553X

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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.


GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

Author: Leonard Steinborn

Publisher: CRC Press

Published: 2004-12-30

Total Pages: 452

ISBN-13: 0203026659

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This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa


Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry

Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry

Author: Carrillo-Cedillo, Eugenia Gabriela

Publisher: IGI Global

Published: 2022-03-18

Total Pages: 298

ISBN-13: 1799896153

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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.