Category Archives: 2026 Training (Jun – Dec)

Effective Root Cause Analysis

DATE: 21 September 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 1 full-day course

INTRODUCTION
Root Cause Analysis (RCA) is one of the most common actions required at every organisation, not only to solve day-to-day operational problems but also to play an important role in other improvement activities such as lean sigma, risk management, etc. Root cause analysis involves searching backwards from an undesirable effect (or problem) to its cause(s) and addressing those causes to effectively prevent recurrence.

This training provides the learner with a basic understanding of the principles and techniques of effective root cause analysis and providing concepts needed to effectively perform investigation.

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

• Understand the principles and techniques of effective root cause analysis.
• Recognise common barriers to root cause analysis and apply techniques to overcome those barriers.
  

COURSE OUTLINE
1. Challenges in root cause analysis
2. Benefits of effective root cause analysis
3. Symptoms vs cause of the problem
4. Contributing factor vs root cause
5. Types of root cause
6. Root cause analysis problem solving model
7. Root cause analysis tools
8. Actions to prevent future problem – corrective action preventive action
9. Human error
10. Root cause analysis in a regulated environment
11. Tips for performing effective root cause analysis

Statistical Process Control and Capability Analysis

DATE: 10 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 the different data types.
• Understand process variation and process stability.
•  Select, analyse, and interpret control charts.
•  Differentiate the different types of process instability.
•  Select the appropriate method to determine the current process capability.
•  Using Minitab software for process control and capability analysis.

COURSE OUTLINE
1. Discrete data and continuous data
2. Minitab navigation
3. Determine process capability
4. Identify process instability and develop improvement strategies
5. Use the right control chart

NCR/ CAPA/ Complaint Handling

DATE: 7 & 8 September 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 2 full-day course

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

Hypothesis Testing

DATE: 9 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 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

Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021)

DATE: 17 & 18 August 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 2 full-day course