COURSE - INSTANT STREAMING ACCESS
.addeventatc { background-color:#49b40c!important; color:#ffffff!important; font-size:13px!important; padding:6px 20px 6px 12px!important; /* extra right padding for icon */ border-radius:6px!important; display:inline-flex!important; align-items:center!important; gap:6px!important; /* spacing between text and icon */ position:relative!important; } /* Icon fix */ .addeventatc .addeventatc_icon { position:absolute!important; right:10px!important; /* push icon to right edge */ width:12px!important; height:12px!important; background:url(https://cdn.addevent.com/libs/imgs/icon-calendar-fff-t1.svg) no-repeat center center!important; background-size:14px!important; }
Share:

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. Designed for professionals responsible for device quality systems, product development oversight, and regulatory readiness under evolving FDA inspection practices.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

/* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } /* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } .accordion-header::after { content: "◯"; font-size: 18px; transition: transform 0.25s ease; } .accordion-item.active .accordion-header::after { transform: rotate(90deg); }

REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
/* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } /* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } .accordion-header::after { content: "◯"; font-size: 18px; transition: transform 0.25s ease; } .accordion-item.active .accordion-header::after { transform: rotate(90deg); }
  • Instructor : John E. Lincoln
  • Study time : 120 Minutes
  • Skill Level: Intermediate
  • Course ID: TF1857
  • Assessment & Certification Included
  • Ask the Expert

Watch the Course Now  

Watch the Course Now   

About the 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

Who Must Attend

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Medical Device product development teams
  • Research and Development Departments
  • Engineering Departments
  • Production Departments
  • Operations Departments

Quality training, expert insights, and answers that matter. Know your Expert

John E. Lincoln

John E. Lincoln brings more than four decades of experience in FDA-regulated industries, including leadership roles in quality assurance, regulatory affairs, and engineering. His consulting work has focused extensively on device quality systems, QMS remediation, and regulatory submissions, providing direct perspective on how FDA expectations evolve and how organizations prepare for inspection transitions.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Upcoming Courses

Your TalkFDA Webinar Experience

When you reserve your seat, everything is organized for you — from access to certification from one place.

1. Confirmation
You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.

2. Your Course Hub
Your TalkFDA course page becomes your central hub where you can watch the course, access materials, and manage your learning.

3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

The challenge with training is rarely signing up. It’s what happens afterward, when access, materials, & certification aren’t accessible from one place.
With TalkFDA Courses, Everything you need Live in One Place.
Simple. Organized. Professional.
Go ahead and Take the Course with confidence.

Our students love us ❤️

“Perfect course to prepare for the changes with respect to QMSR Inspections”

Manager, Quality Assurance

“Couldn't have asked for better preparation for our team. The presenter was extremely patient and knowledgeable”

Director, Quality Assurance

“The session primarily served as refinement rather than foundational learning. Real-world examples significantly drove perceived value..”


Quality Engineer

Featured Courses