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Validating Medical Packaging PDF

158 Pages·2002·0.565 MB·English
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by Ronald Pilchik| 2002| 158 pages| 0.565| English

About 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. As specific as this statement is, the FDA does not provide instructions for how to achieve their standards. This handy reference demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.

Detailed Information

Author:Ronald Pilchik
Publication Year:2002
ISBN:1566768071
Pages:158
Language:English
File Size:0.565
Format:PDF
Price:FREE
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