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Podcasts from IFPAC: "Radio Free Emil"

PharmaManufacturing.com

In these audio files, hot off the wire from the 2007 IFPAC Conference, Process Analytical Technologies expert Emil Ciurczak interviews leading PAT authorities from USP, FDA and the pharmaceutical industry.

Editor's Note: Now that Process Analytical Technologies (PAT) have been folded into the broader framework of Quality by Design, some industry professionals have questioned whether FDA's support for PAT remains strong. Any doubts on that score were emphatically laid to rest at this year's IFPAC conference, held in Baltimore, Md., from Jan. 28-31.

Top FDA officials, including Dr. Janet Woodcock, former director of CDER and now the Agency’s Chief Medical Officer and Deputy Commissioner, as well as Moheb Nasr, Director of the Agency's Office of Product Quality, affirmed the Agency's strong support for PAT, from the commissioner level on down.

They also discussed PAT as it relates to Quality by Design but also the Critical Path. Our contributing editor, NIR and PAT expert Emil Ciurczak, interviewed PAT thought leaders for their perspectives, which we present as this series of podcasts (with transcripts).

The Baltimore skyline on a crisp January morning. Photo by Emil Ciurczak.

Keynote Speeches

• Ajaz Hussain's opening remarks



• FDA's Chief Medical Officer and Deputy Commissioner Janet Woodcock on the Critical Path, Quality by Design, risk-based compliance and where they all intersect



• FDA's Director of the Office of Pharmaceutical Quality, Moheb Nasr dissects QbD and the design space



• MIT's Ram Sasisekharen on biopharma, QbD and PAT

RELATED LINKS

• Sasisekharan Laboratory Web Site

IFPAC Exhibitors' Offerings

Click here for a list of IFPAC exhibitors, with live links to their product videos, websites, on-line demos and more.