US FDA

FDA QMSR - 21 CFR Part 820

What changed when FDA replaced the Quality System Regulation with QMSR and adopted ISO 13485 by reference.

What this course covers

This course covers the Quality Management System Regulation, which replaced the former Quality System Regulation and adopts ISO 13485 by reference for US medical device manufacturers. It works through design controls under 820.30, document and record control expectations, CAPA requirements under 820.100, and purchasing controls and nonconforming product handling.

Who this course is for

Medical device quality and regulatory affairs staff
Combination product manufacturers navigating both drug and device requirements
Anyone transitioning a quality system from legacy QSR to QMSR

What you'll learn

What changed when FDA replaced the Quality System Regulation with QMSR and adopted ISO 13485 by reference
Design control requirements under 820.30
Document and record control expectations under QMSR
CAPA requirements under 820.100 and how they compare to drug-side CAPA expectations
Purchasing controls and nonconforming product requirements

Why it matters

QMSR represents one of the most significant changes to US device regulation in decades. Sites still operating on legacy QSR assumptions risk a widening gap between their quality system and current FDA expectations.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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