portada Validating Medical Packaging (en Inglés)

Validating Medical Packaging (en Inglés)

Formato

Libro Físico

Autor

Ronald Pilchik

Editorial

CRC Press

Año

2002

Idioma

Inglés

N° páginas

160

Encuadernación

Tapa Dura

Dimensiones

23x17.4x1.4 cm

Peso

0.39 kg.

ISBN

1566768071

ISBN13

9781566768078

Categorías

Diseño, arte industrial y comercial, ilustración
Equipamiento y técnicas médicas
Diseño técnico

Validating Medical Packaging (en Inglés)

Ronald Pilchik (Autor) · CRC Press · Tapa Dura

Libro Nuevo Importado

Envío: 17 a 24 días háb.

$ 720.42$ 360.21

-50%

Costos de importación incluídos en el precio ✅

Libro Nuevo

Última Unidad

$ 360.21

Llega entre el 17 Sep y el 30 Sep a Quito, Pichincha. Seleccionar ubicación

Agregar a lista de deseos

Reseña del libro "Validating Medical Packaging (en Inglés)"

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 author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.