Welcome Speech

submitted by: PharmaMfg

Welcome presentation by Eastman Chemical’s Stephen Jacobs

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).

Calibration with a Finnish Flair

submitted by: PharmaMfg

Methods of science-based calibration have come a long way in a few years. Gary Ritchie sits down with VTT Chief Science Officer Ralf Marbach to find out how.

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.

Infometrix's Dr. Brian Rohrback on COPA

submitted by: PharmaMfg

Gary Ritchie and Infometrix's Dr. Brian Rohrback discuss the Chemometrics for Online Process Analytics Initiative at IFPAC 2009.

Cooley and Ciurczak on Online HPLC Analysis

submitted by: PharmaMfg

Process HPLC has come a long way, and Rick Cooley, formerly of Lilly and currently of Dionex, gives Emil Ciurczak a cook’s tour of the new Integral, whose modular functionalities make it suitable for the lab or process plant.

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