Mr Flemming Simonsen, Senior Director – Global QA, Quality System & Tools, Ferring International Center SA, Switzerland will be sharing with us more about quality risk management at Pharma Manufacturing World Asia 2012, part of a series of conferences in the 5th Annual BioPharma Asia Convention 2012
Mr Simonsen is Senior Director in the Global Quality Assurance division of Ferring Pharmaceuticals and is overall responsible for the Quality Management System incl. requirements for computer compliance. He is also system owner of the Global TrackWise quality tracking system, the Global LabWare LIMS system and the Global SOP system – being responsible for design, configuration, implementation, validation and maintenance of these systems.
He graduated as Electronic Engineer in 1982 at the Danish Technical University of Copenhagen. In the first years of his career he has worked as software developer, test manager, department manager, and project manger on various projects in the defence and transportation industry. Since 1989 he has been working in the quality assurance field in various industries such as defence, aerospace, telecommunication, railway technology, air traffic control, construction work and infrastructure, mobile communication and pharmaceutical manufacturing. He is a certified Lead Auditor with special focus on computerised systems and has executed numerous audits both internally and externally. He has been speaker on various conferences in Europe and USA and he is co-writer of the GAMP Good Practice Guide – Testing of GxP Critical Systems
These are some of the issues My Simonsen will address:
1. Risk Management is a growing demand from authorities
2. Get an overview of the Ferring Process for quality risk management
3. Learn how to support the process by the use of a computerised system for registration and tracking
4. Examples on risk communication with authorities