FDA QSR / QMSR Audit Prep

Operational playbook for FDA inspection preparation under Quality System Regulation (21 CFR 820) and the transitioning Quality Management System Regulation (QMSR, fully effective 2026, harmonizing with ISO 13485:2016).

When to use this skill vs. fda-consultant-specialist:

• This skill: FDA inspection imminent OR 483/Warning Letter received; need sprint
• fda-consultant-specialist: building / maintaining QMS; multi-quarter

When to use this skill