● One of the stories focuses on a discussion by the Supplier Quality Working Group chair Barbara Falco’s on the consortium’s effort to drive forward the implementation of the IPAC-RS GMP guidelines for OINDP component manufacturing and supply – including the work with UK’s Pharmaceutical Quality Group (PQG) to extend the reach of its global PS-9000 certification standard into the inhalation arena.
● A second story in our Monthly Update for April addresses thought-provoking presentations by Ron Kaye, who leads the CDRH’s Human Factors and Device Use Safety Team, and Pfizer’s Paul Lucas on the industry/regulator dialogue on developing a viable approach to HF/usability analysis for combination products in the US and Europe.
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