Category Archives: 2026 Training (Jun – Dec)

Hypothesis Testing

DATE: 16 November 2026 (Mon)

TIME: 9.00am – 5.15pm

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

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

• Differentiate different data types.
• Understand variation.
• Develop a hypothesis statement to test assumptions and conjectures.
• Use statistics to validate assumptions and root causes.
• Analyze data with the use of statistical software.
• Select the right tools for comparison.
• Perform correlation and regression analysis.
• Interpret the analyzed information.

COURSE OUTLINE
1. Types of data
2. Variation
3. Basic statistics
4. Minitab navigation
5. Identify potential root causes
6. Validate root causes
7. Correlation & regression analysis

ISO 13485:2016 Internal Audit

DATE: 21 & 22 October 2026 (Wed & Thur)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
A robust internal audit program is an essential requirement for maintaining compliance with ISO 13485:2016 and ensuring the consistent quality and safety of medical devices throughout their lifecycle.

This course equips participants with the knowledge and practical skills needed to plan, conduct, report, and follow up on internal audits systematically and effectively. The training emphasizes understanding process-based auditing, identifying compliance gaps, evaluating the effectiveness of the Quality Management System (QMS), and driving continual improvement within the organization.

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

• Understand the purpose, structure, and key requirements of ISO 13485:2016.
• Explain the principles, responsibilities, and ethics of internal auditors.
• Apply a process-based auditing approach aligned with ISO 19011 guidelines.
• Plan, prepare, and execute internal audits effectively using audit tools and checklists.
• Evaluate evidence, identify nonconformities, and assess process effectiveness.
• Document findings in a clear and objective audit report.
• Verify corrective actions and contribute to continual QMS improvement.
• Strengthen organizational compliance with regulatory and customer requirements through a strong internal audit program.
  

COURSE OUTLINE
1. Introduction to auditing quality management system

• Dilemma of internal quality audit
• Auditing fundamental
• Why audit is essential
• Audit requirements: FDA QSR/ QMSR & ISO 13485:2016
• ISO guideline in auditing management system
• The role of internal quality audit
• Why audit
• What to audit
• Management responsibility
• Management Representative responsibility

2. Types of audit
3. Principles of auditing
4. Internal audit process
5. Application of PDCA in audit process
6. Managing audit program

• Establish program objectives
• Determine audit program risk & opportunities
• Establish audit program
• Implement audit program
• Monitor audit program
• Review & improving audit program

7. Conducting the audit

• Preparing audit
• Conduct audit
• Prepare audit report
• Audit follow up
  

8. Auditor competency
9. The future of internal quality audit
10. Understand ISO 23485:2016 QMS from auditor perspective 

• Introduction
• Mandatory documentation
  
• Clause by clause interpretation from auditor perspective

Medical Device Quality System: ISO 13485:2016 & US FDA Quality Management System Regulation

DATE: 19 & 20 October 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
The medical device regulatory landscape is evolving toward global alignment. With the release of the US FDA Quality Management System Regulation (QMSR), which formally incorporates ISO 13485:2016 by reference, manufacturers now face a harmonized quality system framework that supports compliance across both U.S. and international markets.

This training provides a comprehensive understanding of ISO 13485:2016 requirements and the new US FDA QMSR (21 CFR Part 820), highlighting how these two systems are interconnected. Participants will gain insight into the key similarities, differences, transition expectations from the previous US FDA Quality System Regulation (QSR) to the new QMSR model, and best practices for inspection readiness. Through structured explanations, the course will help participants build practical knowledge on how to apply both ISO 13485:2016 and US FDA QMSR requirements effectively in their quality management systems.

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

• Understand the structure, purpose, and intent of ISO 13485:2016 as a quality management standard for medical devices.
• Interpret ISO 13485:2016 requirements clause by clause.
• Understand the key functions and roles of the US FDA in medical device regulation.
• Overview of FD&C Act and CFR.
• Prepare for FDA inspections and audits.
• Understand key highlights of the new Quality Management System Regulation (QMSR).

COURSE OUTLINE
1. Introduction of ISO 13485:2016
2. 7 Quality Management System Principles
3. Clause by Clause Interpretation of ISO 13485:2016
4. Introduction of US FDA

• The US Food and Drug Administration (FDA)
• The Federal Food, Drug, and Cosmetic Act (FD&C Act)
• The Code of Federal Regulations (CFR)
• Importance of Compliance with US FDA QMSR

5. FDA Inspection

• Introduction
• FDA Inspection Flow
• Quality System Inspection Techniques (QSIT)
• Medical Device Quality System: ISO 13485:2016 & US FDA Quality Management System Regulation
• Preparation and Expectation
• FDA Inspection Outcome
• Response to FDA Observations/ Form 483

6. Quality Management System Regulation (QMSR)

• Introduction
• Overall Highlight of Main Changes
• Summary of Key Changes
• QSR vs QMSR Section Comparison
• QMSR Section by Section Requirements Interpretation
• Executive Summary for Medical Device Manufacturer