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Pharma Show

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

Hosted By :  Pharma IQ
September 10, 2010




Rate this Podcast: (3.9 Stars | 8 Votes)

Tags : Peter Schiemann | GCP | good clinical practice | auditing | compliance | good clinical practice auditing and compliance | in-house audit programmes | quality risk based model | quality risk management | clinical trials | Clinical Trials Directive


About this Podcast...


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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Rate this Podcast: (3.9 Stars | 8 Votes)




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