Can PCMO and PQLI Work in Harmony for Paradigm Change?

PDA has stepped up its efforts to get its training and technical reports more in tune with ICH and a more risk- and science-based industry. These efforts have been underway, says PDA's Rich Levy, but the Paradigm Change in Manufacturing Operations initiative puts them into focus.

PDA has drafted a dossier around four key themes: Life Cycle Approach, Quality Systems, Process Management, and Quality Risk Management, and will use this dossier as the umbrella under which ongoing efforts will be undertaken.

In this article from my recent discussion with Levy, he goes out of his way to emphasize that PCMO is intended to complement, not counter, PQLI efforts already underway at ISPE.

--Paul Thomas

PDA Releases Dossier for Paradigm Change Initiative

PDA has instituted a new "Paradigm Change in Manufacturing Operations" (PCMO) initiative, based largely on encouraging ICH guidance within its organization and the industry. Here is the PCMO dossier, and we'll be following up with PDA in the near future.

--Paul Thomas