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 You Will Learn
Regulatory framework EU and ICH
Quality management, defining quality, risk-based approach to audit and inspection
Trial audit in practice
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.
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
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Hotel & Travel
The DIA has blocked a limited number of rooms at the following hotel:
Holiday Inn London – Kensington Forum
97 Cromwell Road
SW7 4DN London
Tel.: +44 207 341 8000
at the rate of:
GBP 165.00 per room/night inclusive of breakfast and VAT.
In order to make your reservation, please contact the hotel directly at + 44 (0) 207 341 3355 and quote the booking reference ZNK.
Important: The room rate is available until 22 September 2014 or until the group block is sold-out, whichever comes first.
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52