Survival guide to FDA inspections: Part 3, responding to observations

Survival guide to FDA inspections: Part 3, responding to observations

You survived the FDA inspection. Now what? FDA always finishes the inspection by leaving you with a list of its observation. Part 3 concludes the survival guide series by describing the steps every company should take after the inspectors leave--from developing a corrective action plan to writing a...

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Veröffentlicht in:Biopharm International 2002-11, Vol.15 (11), p.42
Hauptverfasser: Lavian, Massoud, Allen, Paul W
Format: Magazinearticle
Sprache:eng
Schlagworte:
Biotechnology
Committees
Documentation
Drugs
Inspections
Investigations
Laws, regulations and rules
Manufacturing
Pharmaceutical industry
R&D
Research & development
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Zusammenfassung:You survived the FDA inspection. Now what? FDA always finishes the inspection by leaving you with a list of its observation. Part 3 concludes the survival guide series by describing the steps every company should take after the inspectors leave--from developing a corrective action plan to writing a detailed response document.
ISSN:1542-166X
1939-1862