Ensuring In-House Audit Programmes are Strategically Focused through Implementing Risk Models

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Ensuring In-House Audit Programmes are Strategically Focused through Implementing Risk Models

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20% of all clinical trials are now subject to regulatory audits! With inspectors’ expectations continually evolving and an increasing number of regulatory warnings, relating to record keeping and informed consent, it is more important than ever to comply with GCP and be inspection ready. Dr. Peter Schiemann, Global Head Quality Risk Management at F. Hoffmann - La Roche, joins Andrea Charles from Pharma IQ, to discuss the key drivers behind why more organisations are adopting a quality risk based model, when auditing multiple clinical sites and ensuring in-house audit programmes are strategically focused.

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