Category Archives: 2026 Training (Feb – May)

FDA QSR to QMSR: Understanding FDA’s New Requirements & Inspection Expectation

DATE: 14 & 15 December 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
The U.S. FDA has introduced the Quality Management System Regulation (QMSR) to modernize medical device quality system requirements and align them more closely with ISO 13485. This regulatory transition marks a significant shift from the traditional Quality System Regulation (QSR) framework and will directly impact how manufacturers design, implement, and demonstrate compliance during FDA inspections.

This training provides a structured and practical understanding of the QSR-to-QMSR transition, highlighting key regulatory changes, inspection focus areas, and compliance expectations. Participants will gain clarity on what has changed, what remains, and how to prepare their quality systems and organizations for FDA inspections under the new QMSR environment.

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

• Understand the regulatory intent and structure of FDA’s Quality Management System Regulation (QMSR).
• Explain the key differences and alignments between legacy QSR (21 CFR 820) and QMSR.
• Identify new and modified FDA requirements resulting from ISO 13485 incorporation.
• Interpret FDA inspection expectations under QMSR.
• Assess the impact of QMSR on existing quality system processes.
• Recognize common inspection risks and compliance gaps during the transition period.
• Prepare an effective QMSR transition and inspection readiness strategy.

COURSE OUTLINE
1. 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

2. Quality Management System Regulation

• Introduction
• Overall highlight of main changes
• Summary of key changes
• QSR vs QMSR section comparison
• QMSR section by section requirements interpretation

3. FDA inspection

• Introduction
• FDA inspection flow
• QSIT (Quality System Inspection Technique)- How FDA traditionally inspected (Pre-February 2026)
• The new QMSR inspection era: What replaced QSIT (Post-February 2026)
• What’s changing in QMSR inspection
• Key QMSR requirements with inspection implications
• Expectation and preparation: Pre-inspection & during inspection (do’s & don’ts)
• FDA inspection outcome
• Response to FDA observations/ Form 483

4. Executive summary for medical device manufacturer

5. Extra information

• Gap analysis – Identification of current QSR documentation to be removed & maintained under the new QMSR framework.
• Gap analysis – FDA QSR vs. FDA QMSR vs. ISO 13485:2016
• FDA QMSR readiness checklist (For QSR to QMSR transition)

Lean Manufacturing

DATE: 2 & 3 November 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

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

• Understand and identify the key principles of Lean Manufacturing.
• Understand and identify the 7 Wastes.
• Develop SIPOC and Value Stream Mapping.
• Utilize the Lean Best Practices to improve productivity.
• Engage your staff or teammates through process values stream mapping, analysis and improvement.
• Differentiate between Lean project and Lean management implementations.

COURSE OUTLINE
1. Introduction to Lean Manufacturing
2. The Operational ‘Waste’ (The 7 Lean Wastes)
3. Value stream map, bottleneck and constraint
4. Lean Best Practices: Takt Time, Kanban, Cell Layout, Schedule Board, Pull, Visual Management and 5S
5. Flow management technique

PREREQUISITE
For effective learning, participants are required to attend the Process Mapping training before attending this Lean Manufacturing training. We will use the data from Process Mapping for Lean Manufacturing.

Process Mapping

DATE: 22 October 2026 (Thur)

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 the differences between process, major steps and activities.
• Map macro process model and detailed process map.
• Understand the principles of value-adding to customers.
• Systematically identify mistake risks in the business process.
• Improve cost, delivery and quality.

COURSE OUTLINE
1. Introduction to process and process mapping
2. Process mapping tools such as SIPOC and Cross Functional Process Map
3. Process analysis tools such as value adding analysis and risk analysis
4. Features of an ideal process
5. Strategies to improve current ‘as is’ process
6. Process management method and tools