Another person who has his finger on the pulse of QbD, and whom I've spoken to a few times in the past six months, is Oracle's Arvindh Balakrishnan. We spoke again last week to touch base, and the focus of our discussion was Balakrishnan's belief that QbD is at a turning point in that many manufacturers have gone beyond the "hodge podge" approach that defined earlier QbD efforts and now have coordinated, corporatewide QbD programs.
Here is the audio of the interview.
--Paul Thomas
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