FDA's QMSR Is Live! Compliance Group Brings Industry Experts Together to Discuss CSA in the QMSR Era | Live Webinar on Feb 26, 2026, |11:00-11:45 AM EST

Illinois, Chicago, US: Compliance Group (CG) is hosting a live webinar titled "CSA in the Era of QMSR: How FDA's New Regulation Redefines Assurance Expectations," addressing a major regulatory shift for the medical device industry.

With the U.S. FDA's Quality Management System Regulation (QMSR) now LIVE and in effect, medical device manufacturers operate within a new framework that aligns quality requirements with ISO 13485:2016. The regulation introduces risk-based thinking, lifecycle oversight, and stronger quality management principles across operations.

Simultaneously, the FDA's Computer Software Assurance (CSA) guidance is shifting software assurance expectations from traditional checklist-based validation to a risk-based, patient-focused approach. Collectively, QMSR and CSA are redefining the integration of quality systems, software assurance, and inspection readiness.

What Will Attendees Learn?
The webinar will provide practical, real-world guidance on:
-How QMSR reshapes FDA expectations for quality systems and inspections
-Practical applications of CSA for production and quality system software
-Strategies to integrate CSA into the quality system
-Approaches to reduce documentation burden while maintaining inspection readiness

Speaker Panel:
-Garth Conrad, Vice President, Quality, Flex Health Solutions
-Francisco Vicenty (Ex-FDA), Director, Continuous Improvement, ACT Quality & Regulatory, Getinge
-Jason P. Dow, Principal Consultant, Compliance Group
-Hillary Driscoll, IT Quality Industry Lead, Validation, Compliance Group

Moderated by:
-Khaled Moussally, EVP & Managing Partner, Compliance Group

Who Should Attend?
The webinar is designed for Quality Assurance and QMS leaders, Regulatory Affairs and Compliance professionals, CSA and CSV practitioners, validation specialists, quality engineers, risk managers, internal auditors, inspection readiness teams, IT partners, and senior management.

Why Attend?
Compliance Group empowers your organization to interpret and apply FDA guidance effectively, providing tested models and clear steps to meeting QMSR and CSA requirements. Attend to gain clarity, confidence, and direct solutions for current regulatory demands.

Register Here: https://register.gotowebinar.com/register/9141235672409217628

Compliance Group Inc
1512 Artaius Pkwy, Suite #104 Libertyville, Illinois
United States, 60048

At Compliance Group Inc., our strength lies in our people, a team of seasoned FDA collaborators, regulatory experts, and validation engineers with decades of experience in the life sciences industry.
We deliver quality and compliance consulting, managed validation services, and AI-driven digital transformation solutions that bridge innovation with regulatory excellence. From CSA-based validation and data integrity remediation to QMS optimization and digital validation enablement, Compliance Group helps organizations confidently transform while remaining inspection-ready.

This release was published on openPR.