A Pragmatic Application of QbD: Turning Theory into Tangible Success
Event Date: May 02, 2013 at 11:00 AM EDT
A well-designed Quality by Design (QbD) approach to drug development and manufacturing can substantially minimize development and scale-up challenges and increase the reliability of the manufacturing process. While a wealth of information exists on the theory behind QbD, there is no “one size fits all” application of it. For a project to reap the added benefits of quality and robustness resulting from QbD, it is critical to understand how to use some of the QbD tools to identify and control the factors contributing to product variability. For example, reduced product variability from QbD can lead to cost savings as a result of decreased batch failure during routine manufacture.

During this 60-minute webcast, two industry experts will share case studies and their experience with QbD and offer insight into how the practical application of QbD contributed to the success of their projects — steps that can be universally applied to your projects.

Don Barbieri, associate director of formulation and process development, Patheon, will present case studies demonstrating different aspects of the QbD approach, including identifying CQAs (critical quality attributes) and CPPs (critical processing parameters) as well as risk assessment determination, risk mitigation, DoE, and more.

David Smith, pharmaceutical specialist, formulation and process development, Patheon, will present a case study where the pragmatic application of QbD enabled a successful tech transfer of a film-coated tablet from Phase III to commercial scale.


Moderator:

Patrica Van Arnum

Executive Editor
Pharmaceutical Technology

Speakers:

David Smith

Pharmaceutical Specialist, Formulation and Process Development
Patheon

Donald Barbieri
Associate Director of Formulation and Process Development
Patheon


IMPORTANT - PLEASE READ
This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Kristen Farrell, kfarrell@advanstar.com.

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