ENGLISH

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

By Medina C. (ed.)

Book information

Year
2004
Language
english
Format
ZIP
Filesize
8 MB (8212864 bytes)
Edition
1st edition
Pages
645\59
Library
mexmat
Time added
2009-11-09 02:42:13

Description

Complying with the regulations of the US Food and Drug Administration is more of an art than a science, says Medina (president, Precision Consultants, Inc.). He presents 17 papers addressing some of the more important compliance and quality systems used in FDA-regulated industries related to medical devices, pharmaceuticals, and biologics. Specific topics include validating analytical methods for pharmaceutical applications, stability testing, computer validation, vendor qualification, internal audit programs, and strategic planning for compliance and regulatory defensiveness.

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