Category Archives: 2026 Training (Jun – Dec)

29 July 2026: Effective Root Cause Analysis

Effective Root Cause Analysis

DATE: 29 July 2026 (Wed)

TIME: 9.00am – 5.15pm

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

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

COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 8 July 2026)

AMMI Member: RM 999.00
Public: RM 1,107.00

Normal Price (from 9 July 2026)
AMMI Member: RM 1,107.00
Public: RM 1,215.00

Option 2: Online (via Zoom)
Early Bird Price (until 8 July 2026)
AMMI Member: RM 826.20
Public: RM 934.20

Normal Price (from 9 July 2026)
AMMI Member: RM 934.20
Public: RM 1,042.20

 

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

20 – 21 July 2026: Medical Device Change Control

Medical Device Change Control

DATE: 20 & 21 July 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement change 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)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 29 June 2026)

AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 30 June 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 29 June 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 30 June 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

 

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

30 June 2026: Design of Experiments 

Design of Experiments

DATE: 30 June 2026 (Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Olive Tree Hotel, Penang
Option 2: Online (via Zoom)

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

COURSE FEES (8% SST Included)

Option 1: Olive Tree Hotel, Penang
Early Bird Price (until 9 June 2026)

AMMI Member: RM 999.00
Public: RM 1,107.00

Normal Price (from 10 June 2026)
AMMI Member: RM 1,107.00
Public: RM 1,215.00

Option 2: Online (via Zoom)
Early Bird Price (until 9 June 2026)
AMMI Member: RM 826.20
Public: RM 934.20

Normal Price (from 10 June 2026)
AMMI Member: RM 934.20
Public: RM 1,042.20

 

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

29 June 2026: Measurement System Analysis

Measurement System Analysis

DATE: 29 June 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:

  • 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

COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 8 June 2026)

AMMI Member: RM 999.00
Public: RM 1,107.00

Normal Price (from 9 June 2026)
AMMI Member: RM 1,107.00
Public: RM 1,215.00

Option 2: Online (via Zoom)
Early Bird Price (until 8 June 2026)
AMMI Member: RM 826.20
Public: RM 934.20

Normal Price (from 9 June 2026)
AMMI Member: RM 934.20
Public: RM 1,042.20

 

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

10 – 11 June 2026: Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021)

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

DATE: 10 & 11 June 2026 (Wed & Thu)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
Risk management plays a pivotal role in ensuring the safety and effectiveness of medical devices, safeguarding patient health, and meeting regulatory requirements. With the increasing complexity of medical technologies and global regulatory expectations, manufacturers must adopt robust risk management practices to identify, analyze, evaluate, and mitigate risks throughout the product lifecycle.

This comprehensive training program focuses on ISO 14971:2019 / EN ISO 14971:2019/A11:2021, the globally recognized standards for medical device risk management. These standards outline a systematic approach to managing risks, integrating safety considerations into the design, production, and post-market phases of medical devices.

Key Features:

  • Comprehensive coverage: In-depth understanding of ISO 14971:2019 and EN ISO 14971:2019/A11:2021 requirements.
  • Regulatory alignment: Guidance on integrating risk management into quality management systems and meeting regulatory expectations.
  • Expert instruction: Delivered by experienced professionals with extensive knowledge of medicaldevice regulations and standards.

Take the first step toward strengthening your risk management expertise and ensuring compliance with global standards. Join us in mastering risk management for medical devices to enhance patient safety and product reliability!

 

COURSE OBJECTIVES
This training aims to provide participants with a clear understanding and insight into the EN ISO 14971:2019/A11:2021 requirements. The training takes a look at the major changes in the 2019 update/revision and also covers some of the commonly used risk management tools such as FMEA, FTA, etc.

 

COURSE OUTLINE
1. Introduction
2. Understanding basic principles of risk management

  • Standards & regulation
  • What is risk management
  • The importance of risk management
  • When to initiate risk management
  • Use of risk management

3. EN ISO 14971:2019/A11:2021 requirements

  • Clause 1: Scope
  • Clause 2: Normative Reference
  • Clause 3: Terms and Definitions
  • Clause 4: General Requirements for Risk Management System
  • Clause 4.1: Risk Management Process
  • Clause 4.2: Management Responsibilities
  • Clause 4.3: Competence of Personnel
  • Clause 4.4: Risk Management Plan
  • Clause 4.5: Risk Management File
  • Clause 5: Risk Analysis
  • Clause 6: Risk Evaluation
  • Clause 7: Risk Control
  • Clause 8: Evaluation of Overall Residue Risk
  • Clause 9: Risk Management Review
  • Clause 10: Production and Post-Production Activities

4. EN ISO 14971:2019 background
5. EN ISO 14971:2019 vs EN ISO 14971:2012 vs EN ISO 14971:2009 vs ISO 14971:2007
6. Differences in the structure and content of ISO 14971:2007 vs ISO 14971:2019
7. Review on EN ISO 14971:2019/A11:2021 Annex Z
8. Highlighted changes in EN ISO 14971:2019 vs EN ISO 14971:2012
9. Changes in ISO / TR 24971:2020
10. Summary of what need to be done to meet EN ISO 14971:2019/A11:2021 requirements
11. Extra information

COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 20 May 2026)

AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 21 May 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 20 May 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 21 May 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

 

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