Institute for International Research

Session Topics: Assessing the Most Effective Approaches to Process Validation Designing Effective Experiments in the New Era of Process Validation Advantages, Challenges and Obstacles of Quality by Design Implementation New and Emerging Process Validation Challenges Audience Interactive Panel Discussion: How Will a Quality by Design Filing Impact Process Development? Moderated by: Amit Banerjee, Ph.D, Research Fellow, Global Biologics, Pfizer Inc. Session Highlights: Process Validation Lifecycle: Phase III through Commercial Althea Technologies, Inc. Risk-Based Process Validation: Satisfying the FDA and ICH Q8-Q10 Genentech, Inc Design of Experiments in Process Validation: DOs and DON'Ts HTD Biosystems, Inc. Regulatory Remediation in Process Validation Tunnell Consulting, Inc. An Effective Approach for the Creation of Design Space Pfizer Inc. Validating Single-Use Products Bayer HealthCare Get the Most Out of your Budget with our Concurrent Conferences and Dual Conference Pass We have conveniently co-located and concurrently scheduled IBC's 4th Annual Technology Transfer for Biopharmaceuticals and IBC's 5th International Outsourcing Manufacturing of Biopharmaceuticals Conferences. These conferences are just prior to IBC's 22nd International Antibody Development and Production and IBC's Inaugural Non-Antibody Protein Therapeutics events. We offer significant discounts for attending the week-long event and encourage attendees to take advantage of our Dual Conference Pass.

A recent regulatory push towards achieving a better understanding of processes, while at the same time lowering cost and improving quality, has left many asking the question:

What else can I gain out of my process validation activities and how do I perform them most effectively?

IBC's 13th International Process Validation for Biopharmaceuticals will provide you with the answer to this question and many others by offering industry-leading, proven strategies to maximize your process validation efforts. With an examination of various validation approaches and the process validation lifecycle, this conference will allow you to discover what aspects of your validation activities should warrant further or continuous evaluation.

A blueprint for process validation success.

By providing a strong emphasis on Quality by Design, Design of Experiments and process understanding, IBC's 13th International Process Validation for Biopharmaceuticals will allow you to apply new approaches to process validation and help you establish best practices that you can immediately implement at your organization.

• Learn how to determine what is still unknown or undefined about your validation activities to help you develop a deeper understanding of the processes
• Hear current approaches to assess risk and minimize the amount of time spent and energy exerted when performing validation while still maintaining regulatory compliance
• Discover how to successfully lower manufacturing costs by focusing on process research and the continuous implementation of improvements
• Learn how to apply Quality by Design as the foundation of process validation, achieve regulatory relief and create effective design spaces

Keynote Presentation:
Critical Quality Attributes: The Foundation of QbD and Process Validation
Ron Taticek, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc.

Featured Presentation:
Continuous Improvement in the Low Cost Manufacturing of Bovine Somatotropin
Brad Storrs, Ph.D., Senior Fellow and Bioprocess Technology Lead, Monsanto Company

By attending, you will learn:

• Key factors to consider when approaching pivotal stages of process validation
• Strategies to determine the relationship between process parameters and quality attributes
• Guidelines and tactics to achieve effective, faster and improved in-house regulatory remediation
• Effective methods to understand, evaluate and qualify small scale models