QbD for Biotechnology Products, Where are We Now?
*Kathy Lee, FDA
The implementation of Quality by Design (QbD) has been talked about for many years in the pharmaceutical industry. Only in the last few years have submissions to the Food and Drug Administration (FDA) included implementation of QbD principles. This is especially true for biologics applications. However, the QbD pilot programs initiated by both the Office of New Drug Quality Assessment and the Office of Biotechnology Products have helped industry and the FDA understand the practical implementation of QbD. This talk will focus how QbD principles have been applied for biologic products submitted for review at the FDA and the challenges for not only industry but the FDA to understand and evaluate these applications.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC