This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. 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.
What participants from previous course say:
“All sessions were really good, I would not be able to decide which one I liked more or less”
“Best course I have ever attended!”
“This was a complete and very enriching training. A lot of people coming from various professional backgrounds; So it was very interesting to discuss with all these people.”
“I felt that the entire program was worth the time and the money spent. It was geared for people that had some auditing experience which was good. I especially like the breakout sessions that allowed us to practice what was presented.”
What You Will Learn
Regulatory framework EU and ICH
Quality management, defining quality, risk-based approach to audit and inspection
Trial system and vendor audit in practice
System audits
Communication of audit findings
Inspections by European and other authorities
Who Should Attend
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.
