IBC Life Sciences

New Online Partnering System Information

All attendees of this conference will receive access to our new online partnering system before, during and after the event.

Log in information will be sent to you via email shortly after you have completed the registration process. After receiving your username, you may log in here

Keynote Presentations

Global Regulatory Strategies for Validation and Transfer of Biotech Processes and Products

Robert L. Garnick, Ph.D.
President & CEO
Lone Mountain Biotechnology and Medical Devices, Inc.

"It's Not About the Molecule!": Capability, Competency, and Suitability in Biopharmaceutical Manufacturing

Jeffrey Baker, Ph.D.
Senior Director, Manufacturing Sciences
MedImmune

Featured Presentations

Humira History - The Impact of Global Technology Transfers and Validation - Challenges and Lessons Learned

George Avgerinos, Ph.D.
Senior Director, Humira Technical Operations
Abbott Laboratories

Upstream and Downstream Process Development Using a QbD Approach - Results from the CMC Biotech Working Group

Victor A. Vinci, Ph.D.
Director, Bioprocess Operations, Bioproduct R&D
Eli Lilly and Company

Amit Banerjee, Ph.D.
Research Fellow, Global Biologics
Pfizer Inc.

Stay Connected!

Joined our Bioprocessing Professionals Group Linked In Group

We are entering a new era of process validation due to recent changes in regulatory expectations that will have a dramatic impact on your process validation efforts. At the center of these changes is the implementation of Quality by Design (QbD) which requires a higher degree of process understanding and control.

IBC's Process & Product Validation will give you the information you need to achieve a better process understanding. Our 2010 agenda, will give you a first-hand look at 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. Plus, extensive case studies will provide you with prospective and retrospective on the latest tools & approaches to ensure successful process and product validation.

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

By attending, you will ensure the success of your process and product validation efforts by gaining exclusive insights into:

• Integrating process monitoring of commercial manufacturing as part of the process validation lifecycle within the Quality by Design paradigm
• Applying principles of Quality by Design for drug product validation
• Implementing strategies and infrastructure to achieve good analytical results for process validation
• Evolving process validation approaches to meet the latest requirements and support internal and external transfers
• Improving process understanding from combining risk management with statistical design and lessons learned from previous validation campaigns
• Overcoming challenges specific to upstream and downstream process validation

Get the most out of your budget with our concurrent conferences and 5 DAY ALL ACCESS PASS

We have conveniently co-located and concurrently scheduled IBC's Outsourcing Manufacturing of Biopharmaceuticals, Technology Transfer of Biopharmaceuticals and Process & Product Validation conferences on March 1-2. These conferences are scheduled just prior to IBC's Antibody Development & Production and Recombinant Protein & Complex Biologic Development & Production conferences on March 3-5. We offer significant discounts for attending the entire event and encourage attendees to take advantage of the 5 DAY ALL ACCESS PASS. For complete details visit www.IBClifesciences.com/BDPWeek.