Category Archives: 2026 Training

NCR/ CAPA/ Complaint Handling

DATE: 8 & 9 June 2026

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

INTRODUCTION
This course introduces the concepts needed to understand the requirements of NCR, CAPA and complaint handling under ISO 13485:2016 QMS and US FDA Quality Management System Regulation (21 CFR Part 820). It provides guidance on how to address each of them effectively with a step-by-step process that incorporates root cause analysis & problem-solving tools. 

 

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

• Understand requirements: Learn the key regulations and standards on managing NCR, complaint, and CAPA in the medical device industry.
• Handle NCR effectively: Identify, document, and manage nonconformances to maintain product quality.
• Improve complaint handling: Develop skills to investigate and resolve customer complaints efficiently.
  
• Strengthen CAPA process: Implement corrective and preventive actions to prevent recurring issues.
• Ensure compliance: Build systems that meet regulatory requirements and improve operational performance.
  

 

COURSE OUTLINE
1. Standard and regulatory perspective on NCR, complaint handling and CAPA
2. Nonconformance process flow
3. Tips to prevent nonconformance
4. Sample template for nonconformance
5. How to write an effective nonconformance report
6. Complaint handling process flow
7. Rules of complaint handling
8. Tips for effective complaint handling
9. Sample template for complaint handling
10. Differences between correction, corrective action, and preventive action
11. Steps to create risk-based CAPA process
12. Sample template for CAPA 

Navigating FDA’s Quality Management System Regulation

DATE: 3 & 4 June 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