FDA’s Moore on Where QbD’s Been, and Where It’s Going

submitted by: PharmaMfg

FDA CDER’s Christine Moore, PhD, acting deputy director of the Office of New Drug Quality Assessment, explains how her office is leading the Agency in moving from conceptual QbD to actual implementation. Gary Ritchie interviews (with a cameo from Emil Ciurcak).

Amgen’s Lowe on QbD, Process Scale and Standardization for Biopharma

submitted by: PharmaMfg

Scale is a function of patient requirements and manufacturing productivity, says Amgen scientific executive director Duncan Lowe. Where QbD’s impact will be felt more is in facilitating equipment and knowledge transfer across sites. Gary Ritchie gets the Lowe-down in this IFPAC 2009 interview.

Amgen’s Lowe on QbD, Process Scale and Standardization for Biopharma

submitted by: PharmaMfg

Scale is a function of patient requirements and manufacturing productivity, says Amgen scientific executive director Duncan Lowe. Where QbD’s impact will be felt more is in facilitating equipment and knowledge transfer across sites. Gary Ritchie gets the Lowe-down in this IFPAC 2009 interview.

FDA’s Moheb Nasr’s Keynote Speech

submitted by: PharmaMfg

FDA’s Moheb Nasr’s keynote speech: QbD, Considerations for Analytical Procedures and Control