Description

Quality Assurance Related Courses

You want to know more about auditing and/or the techniques used in GCP-auditing? You do not see the difference between quality assurance and quality control?

This course is designed to provide a basic understanding of the Good Clinical Practice (GCP) audit process in clinical drug development and to demonstrate the importance of audits in ensuring good data quality.
It will include practical tips when faced with or organising an audit,
An overview of quality management, quality assurance and quality control in clinical research will be presented. The role of audits in this context 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 and system audits will be clarified. All steps involved in the audit process - planning, conduct, documentation, follow-up and close-out - will be explained. The course addresses the role of clinical research professionals involved in the audit process such as investigators, Clinical Research Associates (CRAs) and data managers. General expectations and specific requirements from GCP auditors as well as qualification requirements for auditors are included.

 

Course time
09h00 - 17h00
Who should attend

This course is designed for clinical research professionals with previous working experience in a GCP environment. People interested in the ins and outs of Audits. Auditing experience is not required.

Programme highlights
  • Quality and audit concepts
  • Current auditing standards
  • Different approaches to planning and conducting audits
  • Different types of audits
  • Reporting audit findings
Learning Objectives
  • Understand the role of audits within quality assurance
  • Differentiate the various types of audits
  • Be familiar with applicable audit standards
  • Know the data requirements specific to GCP audits
  • Prepare for sites and system audits
  • Evaluate and write audit findings, audit reports and follow-up actions
  • Recognize GCP audits as a method of ensuring data quality

Book a course

No session currently available.
In case of interest, please contact us.
 

Testimonials

Ms. Pilar Schnadenberger
March 2013
Company
PS Clinical Trials & Consulting Services

All of the topics were presented with excellence by a very competent and very experienced trainer. It was a combination of key auditing information and practical tips on application. The attendees of 5 clinical research professionals with various positions and backgrounds made the
interactive discussions and the inputs very interesting and multi-facetted. I also appreciate the helpful instructions in preparing for this course – getting hotel suggestions, directions for the location and any post-course request. Coffee, other drinks, sweets, cookies, cakes and very good sandwiches were all there – very nice and clean facility as well.