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In Peter Baker’s first presentation with Redica Systems on life sciences quality intelligence, he spells out how he sees pharma companies actually reaching the goal of modern quality intelligence, based on FDA guidance, 483s, and other sources-a long road trip with several stops and no shortcuts.
The former FDA investigator and current President of Live Oak Quality Assurance also shares what he thinks firms will need along the way and what they might discover when they get there.
“Everybody’s aiming for this world-class manufacturing,” says Baker in his presentation, “Quality Intelligence: from Data to Intelligence.” But there’s a barrier holding the industry back, keeping firms on a “hamster wheel of deviations and CAPAs, deviations, and CAPAs.”