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Amer Alghabban, Head of the GCP Auditing Group at Merck Serono, joins Helen Winsor from Pharma IQ, to talk about the implementation of GCP and effective auditing of clinical trials. First he discusses where he thinks the main challenges are in ensuring high levels of GCP, as well as the technologies and solutions Merck employs. He also discusses whether quality-based risk management is something that will provide benefit when auditing. Next, Alghabban discusses the application of electronic data capture, the main challenges in satisfying regulatory criteria during audits, how first time approval can be assured and Merck’s approaches.

Alghabban also shares his top tips for effective communication and relationship management with a CRO or trial partner and discusses the implications of poor communication. Finally, he talks about the industry-wide cost-cutting pressures and pinpoints areas, where it might be possible to cut costs during clinical trials and auditing and the different measures that could be taken to achieve this.

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