How to Develop and Manage Qualification Protocols for FDA Compliance
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$70.99
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Product Details
Author:
Phil Cloud
Format:
Hardcover
Pages:
386
Publisher:
CRC Press (August 31, 1999)
Language:
English
Audience:
Professional and scholarly
ISBN-13:
9781574910988
ISBN-10:
1574910981
Weight:
30.75oz
Dimensions:
8.25" x 11"
File:
TAYLORFRANCIS-TayFran_260618045448360-20260618.xml
Folder:
TAYLORFRANCIS
List Price:
$70.99
Country of Origin:
United States
Case Pack:
16
As low as:
$67.44
Publisher Identifier:
P-CRC
Discount Code:
H
Pub Discount:
30
Imprint:
CRC Press
Overview
Focusing specifically on the FDA documentation requirements, How to Develop and Manage Qualification Protocols for FDA Compliance provides readers with concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure that their companies are not at risk. The author discusses key function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates readers can use as their own. Numerous diagrams and graphics are used to illustrate key points.
