Synopsis
Risk Management Basics provides
-a risk management framework for product development, routine operations, and commercial distribution activities that is anchored in the product safety imperatives of the market and the patient.
-an approach to the investigation of OOS results, deviations, complaints and study failures that protects the technical, trouble-shooting environment required to solve real problems, prevents potential problems, and preserves the business values and priorities of the organization.
-a triage system for information monitoring programs and deviation investigations based on risk to product safety that conserves organizational resources.
-examples of "why things go wrong" in high technology industries and how accidents-of-management can compromise corporate profit and product safety.
-a new approach to organizational design that supports a product focused quality system and protects the productive core of the corporation from problems and inefficiencies.
The numerous figures and exhibits featured in Risk Management Basics will teach you, step-by-step, how to form an effective risk management program. This hands-on guide provides the most comprehensive information so you can establish a risk management framework to suite you company's needs.
"synopsis" may belong to another edition of this title.
About the Author
Carol DeSain is the author of Drug, Device and Diagnostic Manufacturing and Documentation Basics. She lives in Tofte, Minnesota. Charmaine V. Sutton helps medical device and diagnostic companies satisfy US and European regulatory expectations during the development, validation, and maintenance of new and modified products, in order to gain FDA approval and CD Mark Certification. She lives in Maple Grove, Minnesota.
"About this title" may belong to another edition of this title.
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Risk Management Basics
Published by
Advanstar Marketing Services, 2000
ISBN 10: 0929870557
ISBN 13: 9780929870557
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Hardcover
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Risk Management Basics
Published by
Advanstar Marketing Services, 2000
ISBN 10: 0929870557
ISBN 13: 9780929870557
Used
Hardcover
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Risk Management Basics: Protecting Profits and Product Safety in Medical Product Industries Through Risk-Based Decision-Making in Change Control, Deviation Investigations
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hardcover. Condition: Very Good. Risk Management Basics: Protecting Profits and Product Safety in Medical Product Industries Through Risk-Based Decision-Making in Change Control, Deviation Investigations This book is in very good condition and will be shipped within 24 hours of ordering. The cover may have some limited signs of wear but the pages are clean, intact and the spine remains undamaged. This book has clearly been well maintained and looked after thus far. Money back guarantee if you are not satisfied. See all our books here, order more than 1 book and get discounted shipping. Seller Inventory # 7719-9780929870557
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Risk Management Basics: Protecting Profits and Product Safety in Medical Product Industries Through Risk-Based Decision-Making in Change Control, Deviation Investigations
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hardcover. Condition: Very Good. This book is in very good condition and will be shipped within 24 hours of ordering. The cover may have some limited signs of wear but the pages are clean, intact and the spine remains undamaged. This book has clearly been well maintained and looked after thus far. Money back guarantee if you are not satisfied. See all our books here, order more than 1 book and get discounted shipping. Seller Inventory # 6545-9780929870557
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