Validating Medical Packaging
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  • Anglický jazyk

Validating Medical Packaging

Autor: Ronald Pilchik

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,... Viac o knihe

Na objednávku, dodanie 2-4 týždne

374.11 €

bežná cena: 393.80 €

O knihe

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.

  • Vydavateľstvo: CRC Press
  • Rok vydania: 2002
  • Formát: Hardback
  • Rozmer: 240 x 161 mm
  • Jazyk: Anglický jazyk
  • ISBN: 9781566768078

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