Survival guide to FDA inspections: Part 1, to prepare or not to prepare, there is no question

Survival guide to FDA inspections: Part 1, to prepare or not to prepare, there is no question

A three-part survival guide to inspections that will sharpen a pharmaceutical company's regulatory compliance picture is featured. The guide addresses common issues that arise during an FDA inspection and provides advice on how to prevent those difficulties.

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Bibliographische Detailangaben
Veröffentlicht in:Biopharm 2002-08, Vol.15 (8), p.20
Hauptverfasser: Lavian, Massoud, Allen, Paul W
Format: Artikel
Sprache:eng
Schlagworte:
Documentation
FDA approval
Guidelines
Inspections
Manufacturing
Pharmaceutical industry
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Beschreibung
Zusammenfassung:A three-part survival guide to inspections that will sharpen a pharmaceutical company's regulatory compliance picture is featured. The guide addresses common issues that arise during an FDA inspection and provides advice on how to prevent those difficulties.
ISSN:1542-166X
1939-1862