| Video Coverage
- IFPAC 2009 Welcome Speech
Welcome presentation by Eastman Chemical’s Stephen Jacobs
- IFPAC: Moheb Nasr Keynote on QbD
FDA’s Moheb Nasr’s keynote speech: QbD, Considerations for Analytical Procedures and Control
- IFPAC 2009: Bruce Davis on PQLI
The Product Quality Lifecycle Implementation (PQLI) initiative was launched b y ISPE as a means to find practical approaches to implementing ICH guidances. Consultant Bruce Davis, one of PQLI's leading voices, speaks with Jack Carroll and Gary Ritchie about pharma's "next big thing."
- IFPAC 2009: FDA’s Moore on Where QbD’s Been, and Where It’s Going
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).
- IFPAC 2009: Mel Koch on Variability and Understanding Quality Attributes
The global market and inherent variability in drug ingredients require that manufacturers take advantage of new sensors, and technologies such as RFID. Melvin Koch of U Washington’s Center for Process Analytical Chemistry (CPAC) looks ahead with Gary Ritchie.
- IFPAC 2009: NIPTE in ‘09
The NIPTE consortium received more than a million dollars from FDA to develop and implement QbD pilot projects. Gary Ritchie asks executive director Prabir Basu where that money will go.
- IFPAC 2009: Chemometrics—Walk Before You Run
Keep chemometrics simple, says Charles Miller, Senior Research Scientist with Eigenvector Research. He walks us through the resurgence of direct calibration, open source software, and other topics of interest.
- IFPAC 2009: Towards 100% Tablet Inspection
Time Domain TeraHertz Spectroscopy may help manufacturers achieve that elusive goal of inspecting every tablet, explains Picometrix’ Mark Kemper in this interview with Emil Ciurczak.
- IFPAC 2009: Calibration with a Finnish Flair
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.
- Infometrix's Dr. Brian Rohrback on COPA
Gary Ritchie and Infometrix's Dr. Brian Rohrback discuss the Chemometrics for Online Process Analytics Initiative at IFPAC 2009.
- IFPAC 2009: PharmaLaser's Pharma LIBS 250
Gary Ritchie explores the Pharma LIBS 250 with PharmaLaser.
- IFPAC: Ritchie and Van Trieste of Amgen
Gary Ritchie’s chat with Amgen’s Martin Van Trieste about Rx360, a new global anticounterfeiting consortium.
- IFPAC 2009: Cooley and Ciurczak on Online HPLC Analysis
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.
- BMS’ Tim Stevens on Science-Based Calibration
What started as Stevens’ quest to apply chemometrics to BMS legacy products has blossomed into the broad application of PAT-based, real-time calibration. Stevens and VTT’s Ralf Marbach (who first outlined the concept in Pharmaceutical Manufacturing in 2006) discuss their collaborative work with Gary Ritchie and muse about future applications for product release.
- Amgen’s Lowe on QbD, Process Scale and Standardization for Biopharma
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.
- The Beauty of a Stable X-axis: FT-Raman for Material ID and More
- Automated, At-Line Cell Culture Analysis
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