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
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 162.00 per room/night inclusive of breakfast and VAT.
In order to make your reservation, please contact the hotel directly at +44 207 341 8000 and quote the booking reference: DDB.
Important: The room rate is available until 16 September 2013 or until the group block is sold-out, whichever comes first.
Kuechengasse 16, Postfach
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52