For QbD and PAT, Are You Part of the In-Crowd (or Outside Looking In)?

Consultant Jack Carroll (one of our editorial advisors) sent in this commentary on a few things that are holding back PAT and QbD, based upon what he's gleaned from the people attending his training courses. From the attendance at these courses, Carroll says, it's clear that there are currently two factions operating in the QbD/PAT sphere--the mavens and learners. In other words, the in-crowd and the outsiders who are looking in (but may have little financial or corporate support for their initiatives).

Carroll writes: "We find a big disconnect between the PAT and QbD in-crowd and those trying to learn the “art.” The principles are sound, obviously, but the buzz-words are understood differently between the mavens and learners."

--Paul Thomas