Conference Compendium

IVT's 2nd Annual QbD

While bio/pharmaceutical companies have embraced the principals of QbD, many have experienced challenges with the complexities of design and implementation of a QbD system. A successful QbD system requires an effective integration of quality standards, business processes for product commercialization and a common vision across all organizational components involved with QbD.  

QbD is becoming increasingly used across the industry as a framework for developing process and articulating process understanding to the regulatory community. This generation of a wealth of data in manufacturing associated with a process could be leveraged to improve the development process. Yet, it often is not, for a variety of reasons, despite the manifest opportunities for improving the efficiency of process design.   

Employing QbD methodology in product development or applying the methodology retrospectively to already commercialized products is a business decision like any other; management needs to understand the cost, the return on investment and the risks.

Making the Case For QbD in Your Organization
James P. Catania, Managing Consultant, Tunnell Consulting

Designing an Effective QbD System
Gary Denney, Director, Product R&D Quality and Supply Chain Management, Eli Lilly and Company

Science-Based Pharmaceutical Product DevelopmentThe Quality by Design Approach
Robert J. Serra, Co-founder/Principal Consultant, QbD Auditing, Inc.

Opportunities for Quality by Design and the Advancement of Pharmaceutical Manufacturing
John Lepore, Ph.D., Senior Director, Chemical Process Development, Merck & Co., Inc.

Implementing a QbD System Company-Wide
Eda Ross Montgomery, Ph.D., Senior Director, Quality: CMC and QbD, Vertex Pharmaceuticals

Implementing a QbD Program To Make Process Validation A Lifestyle Rather than an Event
Justin Neway, Ph.D., Chief Science Officer, Aegis Analytical Corp.

A QbD Approach to Process Qualification of Post-approval Changes for Biotech Products
Tamas Blandl, Ph.D., Principal Scientist, Process Development, Amgen Inc.

Process Predictive Distributions and QbD
John J. Peterson, Ph.D. , Director, Research Statistics Unit, GlaxoSmithKline

Bridging from R & D to Ops with Quality by Design (QbD)
Shailesh K. Singh, Former Wyeth Pharmaceuticals

Experimental Strategies for Implementing Quality by Design
Ronald D. Snee, Ph.D., President, Snee Associates, LLC 

Managing a Global Regulatory Submission: The Saxagliptin QbD Regulatory Experience
Gerald DiDonato, Associate Director, Global Regulatory Sciences CMC, Bristol-Myers Squibb

Applying QbD Principles to Process Validation
Kevin J. Bittorf, Ph.D., Chemical Engineering, MBA, Process Engineer, Associate Director, Formulation Development, Vertex Pharmaceuticals

Implementation of Quality-by-Design (QbD) via a Comprehensive Quality System (ICH Q8, Q9 and Q10)
Bob Mehta, MSQA, MBA, B.S. (Chem), ASQ – CQA, CBA, CRE, CQE, CSSBB, CSQE, Senior Regulatory Compliance Manager, Edwards Lifesciences 

Developing a Roadmap to Implement Quality by Design
Barry (Bir) Gujral, Ph.D., MBA, Associate Director, Quality Engineering, Noven Pharmaceuticals, Inc. and Peter Amanatides, Vice President, QA and QC, Noven Pharmaceuticals, Inc. 

Building Data-Based Knowledge and Skills Needed to Implement Quality by Design
Ronald D. Snee, Ph.D., President, Snee Associates, LLC 

Quality Risk Management and Risk-Based Decision Making
Socrates Kyritsis, Director, Oral Product Development Pharmaceutical Sciences, Merck and Suliman Chawdry, Principal Scientist, Oral Product Development Pharmaceutical Sciences, Merck

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