Venue: Hyatt Regency Islandia
|Event Date/Time: Dec 08, 2003||End Date/Time: Dec 09, 2003|
The conference begins on Day One, December 8th, with an optional pre-conference workshop. This workshop is designed to give the nuts and bolts of process validation from planning to execution to change control. The Main Conference in the afternoon continues with PFIZER speaking on determination of critical process parameters. This is followed by two AMGEN presentations. The first, led by the Associate Director of Corporate Validation, discusses risk based assessment as it pertains to the new FDA initiatives. The second is a special extended session on process characterization and building this into your validation plan.
Day Two, December 9th, kicks off with BAXTER speaking on the early stages of process validation and how to properly prepare validation efforts while in clinical trials. This is followed by BIOMARIN presenting on issues specifically geared toward biopharmaceutical and sterile products. This includes resin reuse, chromatography and viral clearance. The day continues with presentations on cleaning validation managing global compliance and outsouring considerations and challenges. After a breakout panel discussion, the afternoon concludes with sessions dealing specifically with regulatory concerns both in Europe and the Unites States.
The Process Validation for Biotech and Pharmaceutical conference features a highly distinguished and diverse faculty, including:
Alexander Abramov, National Practice Leader, FDA Computer System Validation and Compliance, ERNST AND YOUNG
E.J. Brandreth, Senior Director, Quality Assurance, BIOMARIN PHARMACEUTICALS
Suggy Chrai, President/CEO, CHRAR ASSOCIATES
Edwyn Curtis, PhD, Senior Manager, PFIZER INCORPORATED
Robert Kowal, MS, RPh, Manager, Technical Operations, PHARMACEUTICAL SOURCING GROUP AMERICAS, A DIVISION OF ORTHO-MCNEIL PHARMACEUTICALS
Vince Mathews, Corporate Quality Assurance Consultant, ELI LILLY & COMPANY
Robert Seely, PhD, Associate Director of Corporate Validation, AMGEN
James E. Seely, PhD, Associate Director, AMGEN COLORADO PROCESS DEVELOPMENT
Douglas Stockdale, President & Chief Technology Officer, STOCKDALE INCORPORATED
Steve Weitzel, Director, Validation and Compliance, NOVAFLUX TECHNOLOGIES
Learn from our distinguished faculty and take advantage of this key opportunity to network with industry colleagues