Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO

Overview:

Effective February 2, 2026, FDA’s Quality Management System Regulation (QMSR) became enforceable, replacing the legacy Quality System Regulation approach in 21 CFR Part 820 with a framework that incorporates ISO 13485:2016 and Clause 3 of ISO 9000:2015. On the same date, FDA also moved away from QSIT and began using its updated inspection process under Compliance Program 7382.850. For medical device manufacturers, that means this is no longer a future transition issue. It is the framework they are now expected to operate under.

Since that shift took effect, many companies have been trying to determine what it means in practical terms for inspection readiness, documentation, validation, and quality system oversight. The questions are no longer just about what QMSR says on paper. They are about how FDA will inspect against it, how existing QSR-era procedures and records will be viewed, and whether current practices are aligned with a more explicitly risk-based model. FDA has also made clear that records such as management reviews, quality audits, and supplier audit reports are now inspectable, and that records created before February 2, 2026 may still be reviewed during inspections.

This webinar is designed to help attendees make sense of those changes through a validation-focused lens. It will examine what has materially changed under QMSR, how the new inspection environment differs from the prior QSIT model, where organizations may be vulnerable during the transition, and how validation strategy, risk assessment, automation, and quality system execution should now be viewed together. It also connects that discussion to broader expectations around CSA, CSV, 21 CFR Part 11, and data integrity, in a way that stays grounded in what FDA-regulated companies actually need to understand right now.

For organizations still trying to translate QSR-era thinking into a QMSR-ready operating model, this session will provide a clearer picture of the inspection implications, the structural differences, and the practical mindset needed to move forward with more confidence. The goal is not to overstate the transition, but to help attendees better understand where FDA’s focus now sits, where confusion is most likely to arise, and how a more risk-based and validation-aware approach can strengthen readiness.

Areas covered in the session:

• Quality System Regulation (QSR) History
• Quality Management System Regulation (QMSR)
• QMSR – Final Rule Changes
• QMSR – Automation & Validation
• Strategic Outcomes
• QMSR Inspections
• QMSR Compliance
• QMSR Transition Definitional Differences
• Changes Since QMSR Final Rule Release
• Quality System Inspection Technique (QSIT)
• QMS - Premarket Submission Reviews
• Changes & Impact
• Actionable Steps
• Transformation
• QSR -->QMSR Structural Crosswalk
• Key ISO 13485 Clauses Referenced by QMSR
• CSA Validation Example – Laboratory System
• Example FDA 483 Citations Mapped to QMSR
• Example Inspection Traceability Path
• QMSR Readiness
• Common Pitfalls & How to Avoid Them
• Frequently Asked Questions
• Validation
• CSV & CSA
• GAMP®5, 2nd Edition & CSA Alignment
• Transition from CSV to CSA
• 21 CFR Part 11 (Electronic Records/Signatures)
• Data Integrity
• Q&A

Exclusive Handouts:

• QMSR Readiness Crosswalk & Gap Assessment Workbook
• Scenario-Based Validation / CSA Decision Workbook
• Inspection Traceability & Common Pitfalls Playbook

Why should you attend?

The February 2, 2026 QMSR change has created a lot of real-world uncertainty for FDA-regulated companies. Many teams are still trying to understand what the shift from the old QSR framework to the new QMSR structure means for inspections, documentation, quality oversight, validation activities, and overall readiness. This webinar is designed to help make that transition easier to understand by focusing on the practical questions companies are facing now.

What makes this session especially valuable is Carolyn’s perspective as a validation expert. While many discussions around QMSR stay at the regulation or quality-system level, Carolyn brings a more operational lens to the conversation—helping attendees think through how the new framework connects to validation strategy, CSA, Part 11, data integrity, automation, and inspection preparation in an FDA-regulated environment.

If your organization is still working through how to align existing practices with the new expectations, this session will help you better understand where the pressure points are and what deserves your attention now. You should attend because Carolyn’s experience gives this webinar the kind of practical credibility and grounded insight that professionals need during a live regulatory transition.

What industries will benefit from this training:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

Personnel in the following roles will benefit:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts and Managers
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in internal inspection

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. It will also help those in software development companies who support the life science industries.