It has become increasingly important to know, what to validate, how much, and what the expectations are that the FDA has for your validation plan. This 2003 West Coast Conference provides the necessities of process validation for API's and also goes into specific validation concerns of biopharmaceuticals and sterile products via case study examples, interactive sessions and panel discussions.

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