Radio IFPAC - A Report on IFPAC 2007
IFPAC 2007 Report
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, Maryland, from January 28 - 31.
Top FDA officials, including Dr. Janet Woodcock, the Agency's new 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, the NIR and PAT expert Emil Ciurczak interviewed PAT thought leaders for their perspectives, which we present as this series of podcast interviews (with transcripts).
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 .