Practical GCP Compliance Auditing of Trials & Systems
|Event Date/Time: Oct 06, 2010||End Date/Time: Oct 08, 2010|
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.
Regulatory Framework EU and ICH and Quality Management
Trial audit in practice
Communication of audit findings
Inspections by European and other authorities
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
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.