Category Archives: 2026 Training (Jun – Dec)

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

Medical Device Design Control

DATE: 28 & 29 September 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement design control for medical devices.

 

COURSE OUTLINE
1. Introduction to design control
2. Application of risk management to design control
3. Design control system

• Design and development planning
• Design and development input
• Design and development output
• Design and development review
• Design and development verification
• Design and Development validation
• Design and development transfer
• Design and development changes
• Design history file

4. Validation system (Design/Installation/Operational and Performance Qualification)
5. Statistical tools and techniques
6. Design control – Quality system inspection technique

COURSE FEES (8% SST included)

Early Bird Price (until 7 Sep 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 8 Sep 2026 onwards)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Bonus deal for group registration 
For the 6th pax to 9th pax: 30% discount 
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194

Design of Experiments

DATE: 24 September 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 1 full-day course

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

• Differentiate traditional experimentation and Design of Experiments (DOE) methods.
• Understand and apply crucial DOE concepts.
• Plan a full factorial or a fractional factorial experiment.
• Analyze DOE results.
• Handle confounding effects.
• Develop process models for process predictions and simulations.
• Use Minitab software for DOE analysis.
  

 

COURSE OUTLINE
1. Types of experimentations
2. Minitab navigation
3. Factorial design and analysis for experimentation
4. Develop process models for process performance prediction and simulations
5. Statistical process control

Measurement System Analysis

DATE: 23 September 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 1 full-day course

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

• Understand when you need to use Gage Repeatability and Reproducibility (GR&R) and Attribute Agreement Analysis (AAA).
• Assess the accuracy and precision of measurement process.
• Assess the effectiveness of inspection and grading system.
• Report performance using the correct statistics.
• Identify improvement areas for instrument and inspection system.
• Use statistical and graphical tools to draw conclusions.

 

COURSE OUTLINE
1. Introduction to Process and Measurement Sources of Variation (SOV)
2. Difference between GR&R and AAA
3. How to plan for GR&R and AAA
4. Data collection method analysis
5. How to analyse and evaluate the information
6. Minitab application

Acceptance Sampling Method

DATE: 22 September 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 1 full-day course

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

• The concept of Sampling Plan.
• Advantages & disadvantages of sampling.
• Types of Acceptance Sampling Plan.
• How to use Sampling Plan graphs and tables.
• The relationship between Acceptable Quality Level (AQL) and Operating Characteristic (OC) Curve.
• Overview of Acceptance Sampling Plan for Attribute ANSI Z1.4/ ISO 2859-1.
• The condition when applying Switching Rules and Acceptance Sampling Procedures.
• The uses of Single Sampling Plans for Critical, Major and Minor Nonconformances.
• The use of Lot Formation and Random Sampling.
• The use of Tightened and C=0 Sampling Plans, Multiple Defects Per Unit Sampling Plans, Double Sampling Plans, and Isolated Lot Sampling Plans.

 

COURSE OUTLINE
1. Sampling plan concept
2. Advantages and disadvantages of sampling
3. Types of Acceptance Sampling Plan
4. Sampling plan graphs