Introduction to GCP Auditing in Clinical Trials
European Centre for Clinical Research Training (ECCRT)
Archivo
20.04.2015 Brussels, Belgium
Contenido de curso
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.
Objetivos de formación
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
Destinatario
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.
Oportunidad de trabajos y los campos profesionales mas buscados por personas ya tituladas
CRA, Clinical Research Associate, PM, Project Manager
CRA, Clinical Research Associate, PM, Project Manager
Certificación
ISO9001:2008/ Q-for
ISO9001:2008/ Q-for
Organizador local
ECCRT
ECCRT
Información e inscripción:
Ms. Sunita Kelecom
Investigación clínica
Tipo de título
Certificado de asistencia
Certificado de asistencia
Duración
1 día
1 día
Idioma
Inglés
Inglés
Costos
EUR 950,00
EUR 950,00
Cantacto organizador
Marcel Broodthaers plein 8b5
1060 Brussels
Belgium
Marcel Broodthaers plein 8b5
1060 Brussels
Belgium
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