The landscape of Quality System Regulation has fundamentally shifted. As of February 2026, the FDA has finalized the transition to the Quality Management System Regulation (QMSR), harmonizing 21 CFR Part 820 with ISO 13485:2016. For professionals in biopharma, medical devices, and combination products, this is the most significant regulatory pivot in decades.

This webinar provides mid and senior leadership with the scientific framework and tactical auditing strategies required to navigate this new regulatory environment without disrupting operational velocity.

Why You Should Attend

The move to QMSR isn’t just a “paperwork update”—it is a total shift in how the FDA evaluates your quality culture.

• Understand the “New Inspection Reality”: Learn how the FDA’s approach to inspections has changed now that the internal audit exemption has been removed.
• Global Harmonization: Align your internal audit program to meet both FDA requirements and international standards simultaneously, reducing redundant effort and compliance costs.
• Future-Proofing: Gain insights into how 2026 enforcement trends are shaping the way “Management Responsibility” is documented and defended during audits.
• Survive the New Inspection Protocol: The FDA is sunsetting the QSIT (Quality System Inspection Technique). Learn what the new, harmonized inspection process looks like and how to train your front-room/back-room teams.
• Mitigate Personal Liability: For senior management, the “Management Responsibility” clause (ISO 13485 Clause 5) is now a primary focus for FDA investigators. We’ll show you how to document “suitability and effectiveness” to protect leadership.

What We Will Cover: The Technical Agenda

This webinar provides a deep dive into the high-risk “delta” areas between the old FDA 21 CFR Part 820 and the new QMSR:

• The End of the Internal Audit Exemption: Under the QMSR, the FDA now has the authority to inspect your internal audit reports and management reviews. We will discuss how to transform these records from “vulnerabilities” into “defenses” by demonstrating robust self-correction.
• Scientific Risk Integration: Transitioning from “Risk as a Phase” to “Risk as a System.” We will explore how to audit the integration of ISO 14971 principles into purchasing controls, production, and software validation.
• The Medical Device File (MDF) Architecture: Moving from the Device Master Record (DMR) to the MDF. We will review the scientific documentation required to satisfy the “FDA-specific” additions that ISO 13485 alone does not cover.
• Data Integrity & ALCOA+ in Automated Systems: Auditing the digital thread. How to verify that automated QMS tools meet the heightened expectations for traceability and contemporaneous recording under the new rule.
• Supplier Risk Profiles: Assessing how to audit global supply chains where the QMSR requirements now “cascade” down to component manufacturers and contract service providers.
• Management Review & Accountability: How to document executive oversight to meet the heightened expectations of “Suitability and Effectiveness.”

Who Will Benefit

This session is designed for Mid to Senior Management and specialized professionals within FDA-regulated industries:

• Quality Assurance (QA) & Quality Control (QC) Directors: To refine internal audit programs.
• Regulatory Affairs (RA) Leaders: To ensure submission data aligns with the new QMSR requirements.
• Operations & Manufacturing Managers: To understand the impact of risk-based controls on the shop floor.
• Compliance Officers: To mitigate the risks associated with the removal of audit report exemptions.
• Risk Managers: To synchronize ISO 14971 activities with the broader QMS.
• QA & QC Managers 
• Medical Device Manufacturing Professionals
• Documentation Management Personnel