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Pre-Production Quality Assurance for Healthcare Manufacturers [Hardcover]

G. William Hough (Author), David A. Rawlings (Author), Michael F. Turner (Author)

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Book Description

Publication Date: June 30, 1997 | ISBN-10: 1574910450 | ISBN-13: 978-1574910452 | Edition: 1

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.

#outer_postBodyPS { display: none; } #psGradient { display: none; } #psPlaceHolder { display: none; } #psExpand { display: none; } 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.

Product Details

Hardcover: 292 pages
Publisher: CRC Press; 1 edition (June 30, 1997)
Language: English
ISBN-10: 1574910450
ISBN-13: 978-1574910452
Product Dimensions: 9.5 x 6.3 x 0.9 inches
Shipping Weight: 1.5 pounds (View shipping rates and policies)
Amazon Best Sellers Rank: #5,582,224 in Books (See Top 100 in Books)

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More About the Author

› Visit Amazon's G. William Hough Page

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Inside This Book (learn more)

First Sentence:
There are many definitions of "quality". Read the first page

Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
verified design output, design control requirements, design history file, design stage output, design input requirements, documented quality system, registration body, audit programme, control clause, design control system, quality assurance function, contract review, nonconforming product, manufacturing organisation, certification body, prototype samples, quality records, prototype product, documented procedures, design verification

Key Phrases - Capitalized Phrases (CAPs): (learn more)
Project Specification, Centre of Excellence, Project Master File, Notified Body, Notified Bodies, Project Leader, United States, Programme Manager, Competent Authority, Study File, Activity Owner, Centres of Excellence, Quality Manual

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Books on Related Topics | Concordance | Text Stats

Citations (learn more)

This book cites 4 books:

Total Quality Management by John S. Oakland on page 86, and Back Matter
Ten Commandments (Christian Bookmarks) by Carson-Dellosa Publishing in Back Matter
Management Teams, Second Edition by R Meredith Belbin in Back Matter
Problem Solving (School Mathematics Project 16-19) by School Mathematics Project on page 104

10 books cite this book:

The GCP Harmonization Handbook by Donald E. Maynard in Back Matter
Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
Computer Validation Compliance: A Quality Assurance Perspective by Mary Ellen Double in Back Matter
The QC Laboratory Chemist: Plain and Simple by Clifford Nilsen in Back Matter

See all 10 books citing this book

Books on Related Topics (learn more)

ISO 9000 by Jeanne Ketola

Discusses:

Total Improvement Management by H. J. Harrington

Discusses:

Design Controls for the Medical Device Industry by Richard Bradley

Discusses:

Validation for Medical Device and Diagnostic Manufacturers, Second Edition by Carol DeSain

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