Category Archives: 2025 Training (Nov-Dec 2025)

Medical Device Change Control

DATE: 3-4 December  2025

TIME: 9.00am – 5.15pm

VENUE: Ascott Gurney 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 change control for medical
devices.

COURSE OUTLINE
1. Introduction to medical device change control
2. Change control – ISO and regulatory requirements
3. Changes/ modification to medical devices
4. Medical device change control and risk management
5. Implementing change control process
6. Good documentation practices

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

Failure Mode and Effects Analysis (FMEA) in Medical Device Manufacturing

DATE: 1-2 December 2025

TIME: 9.00am – 5.15pm

ONLINE via Zoom

DURATION: 2 full-day course

COURSE OBJECTIVES

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

• Learn the practical methodologies for applying reformed Failure Mode and Effects Analysis (FMEA) techniques in diverse business scenarios.
• Gain a deep understanding of the integrated risk landscape and its implications for compliance.
• Learn how to develop a rating table that addresses all pillars of risk.
• Use advance FMEA to determine Critical Product Attributes and Critical Process Attributes for subsequent validation and control activities.
• Develop the ability to identify, assess, and prioritize risks within a unified criteria framework.

COURSE OUTLINE

1. The history, benefits and challenges of FMEA
2. When FMEA is needed?
3. Type of FMEAs
4. Design FMEA vs Process FMEA
5. Steps in FMEA process
6. Input for DFMEA & PFMEA
7. Process flowchart / map
8. Conventional FMEA weakness
9. Advance FMEA (AFMEA)
10. Understanding & filling of FMEA template
11. FMEA rating & acceptance criteria: Conventional vs True
12. Pillar of risk – Integrated risk compliance to ISO 13485:2016, ISO 14971:2019, FDA QSR & EUMDR
13. Investigation tools
14. Top 10 mistakes made when apply FMEA
15. Relationship between FMEA vs Validation vs Control Plan
16. AFMEA for Critical Product Attributes and Critical Process Attributes
17. Other risk assessment tools & techniques

Technical Report Writing

DATE: 26 November 2025

TIME: 9.00am – 5.30pm

VENUE: Ascott Gurney Hotel Penang

DURATION: 1 full-day course

COURSE OBJECTIVES
After participating in the training, you will be able to:
• Understand the planning consideration for a technical report.
• Knowledgeable of the normative contents in a technical report.
• Gain an enhanced skill set to deploy when preparing technical reports.

COURSE OUTLINE
1. Guidelines on Objective and Scope
2. Content selection for the intended reader(s)
3. Systematic structural presentation of Findings with clarity
4. Literature review: Its requirements and guidelines
5. The Methodology contents presentation
6. Importance of writing an accurate, concise, impartial, straightforward report
7. Non-text infographics: Types, purposes and labelling
8. References and its effective annotation methods to appendices
9. Summaries and Abstract: Content and guidelines
10. How to write a good Conclusion & Recommendation
11. Proof reading: Methods and guidelines
12. Best practices for technical reports

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

Medical Device Design Control

DATE:   19-20 November 2025

TIME: 9.00am – 5.15pm

VENUE: Ascott Gurney 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
4. Validation system
5. Statistical tools and techniques
6. Design control – Quality system inspection technique

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

NCR/ CAPA/ Complaint Handling

DATE: 17-18 November 2025

TIME: 9.00am – 5.15pm

VENUE: Ascott Gurney Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
This course introduces the concepts needed to understand the requirements of nonconformance
(NCR), corrective action preventive action (CAPA) & complaint handling under ISO 13485:2016 QMS
and US FDA Quality System Regulation (21 CFR Part 820). It also provides guidance on how to address
each of them effectively with a step-by-step process.

COURSE OUTLINE
1. Standard and regulatory perspective on NCR, CAPA and Complaint Handling
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

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