The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as "advanced auditing", have become a basic task of many audit groups and are an essential element of inspections in Europe.



The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.



Key Topics:

Regulatory Framework EU and ICH and Quality Management
Trial audit in practice
Systems audits
Communication of audit findings
Inspections by European and other authorities


Learning Objectives:

At the conclusion of this course, participants should be able to:

Apply common audit methodology principles to clinical trials in Europe and other countries
Compare trial specific and system audits
Formulate audit findings in clear and precise language
Discuss requirements for inspections


Target Audience:

This course is designed to provide practical training for industry auditors and regulatory authority inspectors, who are faced with the challenging task of auditing or inspecting clinical trials and related systems. It will also be of interest to those with managerial responsibilities.

Event Code:
10546