Introduction to GCP Auditing in Clinical Trials

European Centre for Clinical Research Training (ECCRT)
20.04.2015  Brussels, Belgium
Course Content
This course is designed to provide a basic understanding of the GCP audit process in clinical drug development and will demonstrate the importance of audits in ensuring good data quality.

An overview of quality management, quality assurance and quality control in clinical research. The role of audits will be highlighted, as well as the application of current auditing standards, such as ENGAGE and ISO 19011.

The definition and differentiation of study audits.
Learning objectives, training objectives
Understanding the role of audits within quality assurance. Differentiating the various types of audits. Knowing the data requirements specific to GCP audits. Preparing for sites and system audits. Evaluating and writing audit findings & audit reports
Target Audience
The course is designed for clinical research professionals with previous working experience in a GCP environment. Auditing experience is not required.
Typical postgraduate careers and job opportunities
CRA, Clinical Research Associate, PM, Project Manager
ISO9001:2008/ Q-for
Local Organizer

Enquiries and Registration:

Ms. Sunita Kelecom
Clinical Research
Type of degree
Certificate of attendance
1 day
EUR 950,00
Organizer contact info
Marcel Broodthaers plein 8b5
1060 Brussels
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Anästhesie in Entwicklungsländern e. V.European Health Forum GasteinÖsterreichische Gesellschaft für Public HealthCharité International AcademyÖsterreichische Akademie der ÄrzteÄrzte der WeltAlumni Club Medizinische Universität WienCentro per la Formazione Permanente e l'Aggiornamento del Personale del Servizio Sanitario