Institute for International Research

RISK - a four letter word simply defined as the possibility of loss.

However, those four letters are having a giant impact on current approaches to process validation.

» Find out the latest Risk-Based approaches to process validation being implemented by: Amgen, Biogen Idec, Eli Lilly, Genentech, Lonza and Wyeth. » Discover the most effective methods to reduce risk though Platform Processing, Process Characterization, Risk-Based Models and Design of Experiments. Keynote Presentation Process Validation in 2008 - What's the Risk? Anthony Mire-Sluis, Ph.D., Executive Director, Global Product Quality and External Affairs, Amgen Inc. Plenary Panel Discussion: Risk Factors in Biopharmaceutical Company Downsizing and Changes of Governance or Site Moderated by Wolfgang Berthold, Ph.D., Chief Technical Officer, Biogen Idec Plus a panel of industry experts! Featured Presentation Implementing a Global Process Validation Advisory Committee within Your Company Cerlinde Storer, Senior Corporate Validation Engineer, Amgen Inc.

IBC's 12th International Process Validation for Biologicals provides you with the best insights and strategies to tackle the most pressing issue in process validation - RISK. As the biopharmaceutical landscape continues to shift and evolve, successful companies are putting risk assessment at the forefront of process validation activities to ensure that workflow efficiency and profits are maximized. By gaining the most up-to-date knowledge and insight into strategies used by industry leaders, you will be able to implement these tactics immediately into your process validation activities to ensure you are performing "smart" and "value-added" validation.

IBC's 12th International Process Validation for Biologicals has responded to industry demand by designing a conference program that moves beyond theoretical approaches and offers tangible solutions to industry-wide frustrations. You will examine the best methods for managing information workflow, the latest and most effective design considerations and analyze the impact, or potential threat of follow-on biologics and second generation products. With numerous case studies, interactive panel discussions and a distinguished speaker line up, this conference is the best resource to learn how to maximize process validation activities and assess, predict and avoid risk in order to boost efficiency and patient safety.

Program Highlights Include:

• NEW THIS YEAR! - EIGHT case studies evaluating validation processes from Genentech, MedImmune, Pfizer, Wyeth, Lonza and others
• Hear about the challenges and rewards of validating a next generation product through Amgen's experiences
• Discover the latest strategies to enhance the speed of information retrieval and analysis

Participate in TWO Panel Discussions:

• An Examination and Evaluation of the latest Risk Reduction Strategies
• Risk Factors in Biopharmaceutical Company Downsizing and Changes of Governance or Site