Compliance Consultant, formerly F. Hoffmann La-Roche
Energy Kristina Hansen
MilCor Consulting
Thomas Højsholm Schmidt
CSL Behring
Objectives
You will have the possibility to learn and intensively discuss
how to focus on specific GMP related aspects
how to act and react in an audit
Background
Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified personnel performing audits. And GMP audits of suppliers, contract manufacturers and contract laboratories are a fundamental part of a Quality Management System to assure the quality of a drug product. Only knowledgeable and highly qualified auditors with a profound technical knowledge and good communication skills can guarantee audits that are useful for both the auditing company and the auditee.
Recognising this need for further professional knowledge development, the ECA Academy has set up this practice-oriented course which is also part of ECA’s Certified GMP Auditor Programme.
Target Group
This course is designed for both new and experienced auditors. It can also be seen as an addition to the ECA Course “The GMP Auditor”.
Date & Venue
Date Tuesday, 11 November 2025, 9.00h – 18.00h (Registration and coffee 8.30h – 9.00h) Wednesday, 12 November 2025, 8.30h – 17.45h Thursday, 13 November 2025, 8.30h – 15.00h
Venue Austria Trend Parkhotel Schönbrunn Hietzinger Hauptstr. 10-14 1130 Vienna (Wien), Austria Tel.: +43 (1) 878 04 0 E-Mail: parkhotel.schoenbrunn@austria-trend.at
Testimonials
Seminar Programme as PDF