2011 Annual Meeting

Session: Round Table Invited Session On QbD: QbD Filings

Chair

Christine Seymour, Pfizer

Co-Chair

Huiquan Wu, FDA

Presentations

03:15 PM

(407a) Progress In Quality by Design Implementation In Fda's Office of New Drug Quality Assessment

Christine Moore

03:30 PM

(407b) QbD Approaches for Continuous Manufacturing

Fernando J. Muzzio

03:45 PM

(407c) Experiences with Quality by Design Filings and Prior Approval Inspections

Chris Balducci

04:00 PM

(407d) Quality by Design for Generic Drugs

Yingxu Peng

04:15 PM

(407e) To Be Updated

Stefanie Pluschkel

04:30 PM

(407f) QUALITY by Design (QBD), Biopharmaceutical Manufacture

Kurt Brorson

04:45 PM

Panel Discussion: Christine Seymour and Huiquan Wu