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The FDA's PAT initiative was in response to a desire for innovation in manufacturing and quality assurance. Nearly a decade later, industry remains reticent to embrace the principles espouse by the PAT guidance. Tools mentioned in the guidance seem to have been utilized but the goals of the PAT guidance, or for that matter the improvement in manufacturing and quality assurance have not been realized.
|PAT ' a Disjointed Product Approach or an Integrated Solution to Deliver Real Manufacturing Benefits?|
Room: 1E12 ~ 2:00 pm - 3:30 pm (Wednesday, March 30, 2011)
Is this because of "product focused" marketing of PAT tools? Can the PAT framework be embraced and implemented until the venders begin to offer "solution packages" which include PAT tools and principles? Join us for a round table discussion.