Introduction to GCP Auditing in Clinical Trials
European Centre for Clinical Research Training (ECCRT)
Archiv
20.04.2015 Brussels, Belgien
Kursinhalte
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.
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.
Lernziele, Trainingsziele
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
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
Zielpublikum
The course is designed for clinical research professionals with previous working experience in a GCP environment. Auditing experience is not required.
The course is designed for clinical research professionals with previous working experience in a GCP environment. Auditing experience is not required.
Typische Postgraduate Berufsfelder und Berufschancen
CRA, Clinical Research Associate, PM, Project Manager
CRA, Clinical Research Associate, PM, Project Manager
Zertifizierung
ISO9001:2008/ Q-for
ISO9001:2008/ Q-for
Lokaler Veranstalter
ECCRT
ECCRT
Anfragen und Anmeldung:
Frau Sunita Kelecom
Klinische Forschung
Art des Abschlusses
Teilnahmebescheinigung
Teilnahmebescheinigung
Dauer
1 Tag
1 Tag
Sprache
Englisch
Englisch
Kosten
EUR 950,00
EUR 950,00
Veranstalter Kontakt
Marcel Broodthaers plein 8b5
1060 Brussels
Belgien
Marcel Broodthaers plein 8b5
1060 Brussels
Belgien
"GOING INTERNATIONAL fördert den Zugang zu Aus-, Fort- und Weiterbildung, unabhängig von sozialen, geographischen und nationalen Grenzen."
