Introduction to GCP Auditing in Clinical Trials
European Centre for Clinical Research Training (ECCRT)
Archive
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.
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
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.
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
CRA, Clinical Research Associate, PM, Project Manager
Certifications
ISO9001:2008/ Q-for
ISO9001:2008/ Q-for
Local Organizer
ECCRT
ECCRT
Enquiries and Registration:
Ms. Sunita Kelecom
Clinical Research
Type of degree
Certificate of attendance
Certificate of attendance
Duration
1 day
1 day
Languages
English
English
Fees
EUR 950,00
EUR 950,00
Organizer contact info
Marcel Broodthaers plein 8b5
1060 Brussels
Belgium
Marcel Broodthaers plein 8b5
1060 Brussels
Belgium
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