Informa Life Sciences

The third annual Aseptic Filling and Processing Conference will be the place to hear essential regulation updates and case studies about the revised GMP Annex 1.  It is expected that the Annex will have been finalised and being implemented by the time of the conference, and the event will be one of the first to debate its implications.  Experienced industry experts will present their knowledge through case studies, panel discussions, and both pre and post conference workshops enabling you to benchmark your systems.

"Good mix of new technologies, presentations and case studies" GlaxoSmithKline

Key themes this year include:-

• Understanding and implementing major revisions to GMP Annex 1
• Reviewing and applying the changes to ISO 14644
• Risk Assessment / management
• Sterilisation / validation / monitoring/
• Choosing and implementing separative devices
• Critical requirements of aseptic processing
• GSK case study: The upgrade of an existing aseptic facility to conform to upcoming regulations

"Topics are really well chosen and related to the hottest topics of the moment" Sanofi Pasteur

Speakers already confirmed include:-

• Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
• David Brande, Chair, Technical Committee 209, International Organization for Standardization
• Gordon Farquharson, Consultant, Bovis Lend Lease
• Stewart Green, Director of QA, Wyeth
• Ed Whalley, Steriles Strategy Manager, GSK
• Andrew James, Senior Scientist, Sterile Product Development, Wyeth, UK
• Ulla Thomsen, Project Manager Mechanical Engineering, Novo Nordisk, Denmark
• Barbara Sambucco, Quality Development Manager, Bristol Myers Squibb, Italy
• James Drinkwater, Process & Validation Director, Bioquell & RABS Special Interest Group Leader, PHSS
• Brian Midcalf, Chairman, Pharmaceutical Isolator Working Party
• Jon Nottingham, Independent Consultant, Complete Bio-decontamination - Systems, UK
• Bob Johnson, Director, Dialogue Consultancy, UK
• Tim Coles, Isolator Specialist, Pharminox Isolation