Validating medical packaging /

According to the FDA Quality System Regulations, manufacturers must ensure that ""device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution."&...

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Bibliographic Details
Main Author:	Pilchik, Ronald
Corporate Author:	Taylor & Francis
Format:	eBook
Language:	English
Language Notes:	English.
Published:	Boca Raton : CRC Press, ©2003.
Subjects:	Medical instruments and apparatus > Packaging > Standards > United States. Equipment and Supplies > standards Product Packaging > standards United States Médecine > Appareils et instruments > Conditionnement > Normes > États-Unis. MEDICAL > Allied Health Services > Medical Technology. Medicinska instrument och apparater. Förpackningar > standarder > Förenta Staterna. Kvalitetskontroll. Electronic books.
Online Access:	Connect to the full text of this electronic book

Description
Summary:	According to the FDA Quality System Regulations, manufacturers must ensure that ""device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution."" As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the au.
Physical Description:	1 online resource (151 pages) : illustrations
Bibliography:	Includes bibliographical references and index.
ISBN:	1566768071 9781566768078 9781420014945 1420014943 1280648201 9781280648205 9786610648207 6610648204