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).
Keynote Speeches
Radio IFPAC with Emil Ciurczak |
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