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

Table of Contents:

Chapter Appendix
chapter 1 Package Design Validation
chapter 2 Package Process Validation
chapter 3 Putting It All Together
The Validation Protocol
chapter 4 Regulatory Activities.