Applying Risk-Based Approaches & Implementing QbD to Comply with Regulatory Requirements & Achieve Better Process Understanding

03/01/2010
03/02/2010

March 1-2, 2010 • La Costa Resort and Spa • Carlsbad, CA

For 2010, IBC's Process and Product Validation will explore how companies are going to overcome the daunting challenge of capturing and transferring all that information once the paradigm is changed to a QbD approach. Companies will deliver case studies on prospective and retrospective approaches to the implementation of advanced process monitoring mechanisms to improve lifecycle management. The latest tools and effective strategies in drug product validation, including the integration of validation across the entire process will be evaluated. Industry leaders will demonstrate the critical role of analytics in process validation. Sessions will also cover the impact of new viral validation approaches on process validation and the unique challenges of process validation for specific therapeutic proteins. For more information, click here.