Practical Guide to Gmps for Device and Diagnostic Manufacturers : 21 Cfr 820, Effective June 1997 : En 46000, ISO 9000 download torrent
Practical Guide to Gmps for Device and Diagnostic Manufacturers : 21 Cfr 820, Effective June 1997 : En 46000, ISO 9000 download torrent

Practical Guide to Gmps for Device and Diagnostic Manufacturers : 21 Cfr 820, Effective June 1997 : En 46000, ISO 9000 by Steven S. Kuwahara
Practical Guide to Gmps for Device and Diagnostic Manufacturers : 21 Cfr 820, Effective June 1997 : En 46000, ISO 9000
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Author: Steven S. Kuwahara
Number of Pages: 192 pages
Published Date: 01 Jun 1997
Publisher: Taylor & Francis Ltd
Publication Country: London, United Kingdom
Language: English
ISBN: 9781574910254
File size: 33 Mb
File Name: Practical.Guide.to.Gmps.for.Device.and.Diagnostic.Manufacturers.21.Cfr.820,.Effective.June.1997.En.46000,.ISO.9000.pdf
Download Link: Practical Guide to Gmps for Device and Diagnostic Manufacturers 21 Cfr 820, Effective June 1997 En 46000, ISO 9000
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Originally prepared to demonstrate to one manufacturer that the US Food and Drug Administration's new Good Manufacturing Practices standards for medical devices are not so very difficult to meet, nor very different from the ISO 9001 global and EN 46001 European versions of the standards. Aids readers who are not necessarily experts in Quality Assurance or Control to envision the work that would be required to prepare the necessary documents and eventually to implement the quality program. Reviews the standards and their requirements; provides a line-by-line explanation of what the FDA will look for on an inspection and what should be included in the documentation; and offers examples of the best ways to classify, store, prepare, and retrieve relevant data. No bibliography. Annotation c. by Book News, Inc., Portland, Or.

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