Customize Your Learning Experience!

Mix-and-match sessions from these additional co-located conferences at no additional cost:

• Technology Transfer for Biopharmaceuticals
• Outsourcing Manufacturing of Biopharmaceuticals
• Biopharmaceutical Raw Materials throughout the Product Lifecycle
• Viral Safety for Biologicals

Stay for the week so you can attend on Feb. 29 - March 2 for these conferences:

• Antibody Development & Production
• Recombinant Protein & Complex Biologic Development & Production
• Analytical Technologies for Biotherapeutic Development
• Biobetters & Biosimilars: Technologies & Development Strategies

Get the Most Out of Your Budget with the "All Access Pass" to Attend Sessions from All 9 Conferences

View the Agenda-At-A-Glance for the Entire Week.

Special Discounted Hotel Rate

Special Discounted Hotel Rate Available Until February 3, 2012.
To book your room, call 1-800-HILTONS and mention that you are an IBC attendee at this event.

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This conference provides insights into the interpretation and implementation of FDA's Process Validation Guidance and QbD approaches, while examining the roles and impact of knowledge management and quality risk management on continuous verification.

• When considering process validation, are you confounded by the question of "Is 3 batches sufficient"?
• Are you confident that your process is capable of consistently delivering the same quality?
• How do you design the process, demonstrate that it works, and continuously monitor the process to ensure consistency?
• How do you interpret and implement the new Guidance into your existing validation program?

Learn answers to these questions and more at IBC's Process and Product Validation conference.

"Great conference with many valuable topics covered." - M. Kane, Associate Director, Process Statistics, HGSI

Keynote Presentations

Biologics Product & Process Lifecycle Management: Genentech / Roche Experience
David Chang, Ph.D.
Senior Director, Global Biologics Manufacturing Science & Technology
Genentech, Inc., a member of the Roche group

Facility Fit Analysis – The First Step in a Long Journey
Greg Liposky, Ph.D.
Vice President & General Manager, Site Operations
MedImmune

Featured Presentation

Key Elements of Process Design: Risk Assessments, Design Space and Control Strategy
Amit Banerjee, Ph.D.
Research Fellow, Global Biologics
Pfizer, Inc.

Plus, in-Depth Coverage on:

• Progression of Process Validation & Recent Trends
• Linking QbD, Design Space and New FDA Guidance
• Interpreting and Implementing the New FDA PV Guidance
• Process Knowledge and Lifecycle Management in Enabling Continuous Verification
• Trouble-Shooting Chalenges in Process Validation
• Case Studies and Strategies for Manufacturing Facility Control, Protection and Remediation

» View the agenda