Live Webinar

FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality

This course explains how FDA inspections will function after QMSR, clarifying what replaces QSIT, how ISO 13485 shapes inspection flow, and what teams must change now to remain inspection-ready under the new process-based model.

   23 February 2026    |       11.00 AM Eastern Time (US/Canada)    |       04.00 PM GMT    |       90 Minutes    |       MD1857

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FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality

This course explains how FDA inspections will function after QMSR, clarifying what replaces QSIT, how ISO 13485 shapes inspection flow, and what teams must change now to remain inspection-ready under the new process-based model.
    John E. Lincoln    |         90 Minutes    |       MD1857
 

Registration to this course includes:

  • Presentation Handout & Templates
  • Certificate of Completion
  • Trial access to TalkFDA Subscription
  • TalkFDA Members-only Community

LIVE - SINGLE

US $290
ONE participant (viewer) – Live session
PLUS Complimentary Streaming access for 2 month

CORPORATE - LIVE

US $990
Up to 10 participants – Live session
PLUS Complimentary Streaming access for 2 months for each attendee

TalkFDA Membership Benefits

Be a part of the exclusive community
Explore how membership complements your learning

Registration to this course includes:

  • Presentation Handout & Templates
  • Certificate of Completion
  • Trial access to TalkFDA Subscription
  • TalkFDA Members-only Community

SINGLE ACCESS

US $290
ONE participant (viewer) – Streaming access for 2 month

CORPORATE ACCESS

US $990
Up to 10 participants – Streaming access for 2 months for each attendee

TalkFDA Membership Benefits

Be a part of the exclusive community
Explore how membership complements your learning

Why take this course?

FDA inspections are changing—quietly, structurally, and permanently. With the Quality Management System Regulation (QMSR) taking effect on February 02, 2026, the familiar QSIT playbook is gone. There is no QSIT 2.0 coming. Instead, inspections are shifting toward a process-based model aligned with ISO 13485, reshaping how FDA evaluates quality systems, risk management, and day-to-day execution.


This change creates a new inspection reality. Companies must now operate in a hybrid space where legacy QSR expectations still matter, while ISO-based thinking drives inspection flow. Inspectors will look beyond subsystem checklists and focus on how processes connect, how risk is embedded, and whether the quality system works as an integrated whole. Teams relying on old QSIT habits will feel the pressure quickly.


This webinar brings clarity to what inspectors will actually do under QMSR—and how organizations should adjust before inspections begin. It helps leaders, QA, RA, and development teams understand where FDA expectations have shifted, where they have not, and how to prepare without overcorrecting. For anyone responsible for inspection readiness, this is not theoretical change. It is operational reality.

  • Inspection clarity after QSIT:

    QSIT defined inspections for decades. Its removal creates confusion across quality and regulatory teams. This course provides a clear picture of how FDA inspections will be structured under QMSR, what inspectors will follow instead of QSIT, and how inspection logic will shift from subsystems to end-to-end processes. That clarity prevents misaligned preparation and wasted effort.


  • Confidence in ISO-aligned inspections:

    ISO 13485 is now incorporated by reference into 21 CFR 820, changing how FDA evaluates compliance. This course builds confidence in understanding where ISO expectations align, where FDA adds emphasis, and how inspectors will assess risk management, process control, and system effectiveness under this hybrid model.

  • Practical Inspection Readiness:

    Teams must be prepared now. This course helps prioritize changes that matter for inspections, allowing organizations to adapt deliberately rather than react under inspection pressure.

Key Areas Covered

What QMSR changes inside 21 CFR 820 and what remains enforceable
Why QSIT is effectively eliminated—and what replaces it in inspections
Process-based inspection structure aligned with ISO 13485:2016
FDA’s increased emphasis on risk management using ISO 14971
Key inspection focus areas beyond ISO 13485 baseline requirements
Identifying surprise elements that could catch teams off guard during inspections
How FDA and global harmonization influence inspection consistency
Practical implications for inspection preparation and execution
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