Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3).
The feature story in the April issue explores how regulators and industry are working together to make quality risk management (QRM) a more effective force in improving quality systems and the regulatory communication process at the review and inspections levels. The three parts of the story provide insights from: ● HPRA’S Kevin O’Donnell on the evolution of QRM and the revision now underway of ICH’s 15-year-old QRM guideline Q9, which he is leading ● FDA’s Rick Friedman, also on the Q9 revision Expert Working Group, on advancing aseptic processes through QRM, and ● industry/academia thought leaders on evolving QRM’s relationship with knowledge management across the product lifecycle.