Process Validation for Biological Production

Venue: Mandarin Oriental du Rhône

Location: Geneva, Switzerland

Event Date/Time: Feb 14, 2005 End Date/Time: Feb 15, 2005
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This practical and case study driven conference will offer key insights into how companies are preparing for and handling regulatory inspections. Top-level speakers with hands-on experience of process validation in a range of biological products will share experiences in areas including: Cell culture, fermentation, purification, down-stream processing, facility changes, cleaning validation, virus removal, stability and formulation.

Benchmark with leading international experts from organisations including:
Genentech, Bayer Healthcare, Biogen Idec, Hoffmann-La Roche, Abgenix, Covance, Sartorius, Cardinal Health, Biovitrum, Protherics UK, DSM Biologics, National Institute for Biological Standards and Control, Millipore. Avecia Biologics, Analysis.
An international panel of speakers will share unique insights into how they are performing process validation today:
§ How other companies are validating processes to pass regulatory inspections: What works, what doesn't
§ Approaches to qualifying critical control parameters in process validation
§ Demonstrating acceptable ranges and methods
§ Successful processes and approaches that have worked prior to and during inspections
§ How to interpret expectations without regulatory guidelines
§ Process validation strategies throughout product development