2- 3 September 2026: Navigating FDA’s Quality Management System Regulation

Navigating FDA’s Quality Management System Regulation

DATE: 2 & 3 September 2026

TIME: 9.00am – 5.15pm

VENUE: Dorsett Grand Subang Hotel, Selangor

DURATION: 2 full-day course

INTRODUCTION
The U.S. FDA Quality Management System Regulation (QMSR) represents a fundamental shift from the legacy 21 CFR Part 820 Quality System Regulation (QSR) to a harmonized, ISO 13485-based framework. While QMSR incorporates ISO 13485:2016 by reference, it retains critical U.S. statutory and regulatory requirements, creating both opportunities and compliance risks for medical-device manufacturers.

 

COURSE OBJECTIVES
After participating in the training, you will be able to:

• Understand the structure, intent, and scope of FDA QMSR.
• Clearly distinguish what changed vs what did not from 21 CFR Part 820.
• Interpret ISO 13485 clauses as enforceable FDA requirements.
• Identify and address QMSR gaps in existing QMS documentation.
• Implement risk-based, lifecycle-oriented compliance.
• Prepare for FDA inspections under QMSR.
• Develop a practical transition and remediation roadmap.

 

COURSE OUTLINE
Day 1 – Understanding QMSR & Structural Alignment

1. Module 1: FDA QMSR – Regulatory Context & Intent

• Why FDA moved from QSR to QMSR
• Harmonization with ISO 13485:2016
• Legal status of ISO clauses under U.S. law
• Effective date, enforcement expectations, and transition period
• Impact on manufacturers vs contract manufacturers

2. Module 2: QMSR Structure & Scope

• QMSR regulatory framework overview
• Relationship between: QMSR / ISO 13485:2016
• FDA statutory requirements
• FDA’s interpretation of “incorporation by reference”

3. Module 3: Clause-by-Clause Mapping – 21 CFR 820 vs. ISO 13485 vs. QMSR

• Management Responsibility (820.20 vs. ISO 13485 Clause 5)
• Design Controls (820.30 vs. ISO 13485 Clause 7.3)
• Purchasing Controls (820.50 vs. ISO 13485 Clause 7.4)
• Production & Process Controls (820.70 vs. ISO 13485 Clause 7.5)
• CAPA (820.100 vs. ISO 13485 Clause 8.5)

4. Module 4: Risk-Based Thinking under QMSR

• Embedded risk-based approach across QMSR
• ISO 14971 risk management
• Process risk (PFMEA)
• Software risk (CSV / GAMP 5)
• Risk proportionality in controls and validation

5. Module 5: Documentation & Record Control under QMSR

• Mandatory documented procedures
• Records vs. documents under FDA expectations
• Electronic records, data integrity, audit trails
• Alignment with 21 CFR Part 11
• Inspection-ready documentation structures

 

Day 2 – Implementation, Inspection Readiness & Transition

6. Module 6: Design Controls & Lifecycle Management

• Design planning, inputs, outputs, verification & validation
• Design transfer and changes
• Design history file (DHF) expectations under QMSR
• Software design & validation alignment

7. Module 7: Production, Process & Supplier Controls

• Process validation & monitoring
• Statistical techniques & sampling plans
• Supplier qualification & monitoring
• Contract manufacturer oversight under QMSR
• Change management & revalidation triggers

8. Module 8: CAPA, Complaints & Post market Surveillance

• CAPA system structure under ISO 13485 & QMSR
• Complaint handling vs. MDR vs. vigilance
• Trending, signal detection & escalation
• Corrections & removals
• FDA enforcement expectations

9. Module 9: FDA Inspection Readiness under QMSR

• How FDA investigators will inspect under QMSR
• Differences from traditional QSIT inspections
• Inspection focus areas & common pitfalls
• Inspection defense strategies
• Responding to FDA 483s under QMSR

10. Module 10: QMSR Transition & Action Planning

• Gap assessment methodology
• Transition roadmap (QSR to QMSR)
• SOP revision prioritization
• Training & competency updates
• Management review & governance