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www.fdanews.com/articles/120587-internal-site-gcp-audits-essential-in-preparing-for-fda-inspections

Internal Site GCP Audits Essential in Preparing for FDA Inspections

September 18, 2009
Internal site audits to ensure compliance with good clinical practices (GCPs) are essential if sites are not to be caught flat-footed by an FDA inspection, Felicia Angus, principal quality assurance specialist at GlaxoSmithKline Consumer Healthcare, said during the Regulatory Affairs Professionals Society conference. She reminded sites that data auditing is a major component of GCP.
Clinical Trials Advisor