Course Code: CPD/O/02/2021
CPD Hours: 14
Quality Risk Management (QRM) offers a systematic, science-based approach to identifying, evaluating, and controlling risks that may affect patient safety, product quality, or regulatory compliance. Regulatory authorities increasingly expect QRM to be fully integrated into the Quality Management System, using appropriate formal and informal tools in line with ICH Q9 principles, including risk assessment, risk control, risk review, communication, and acceptance of residual risk.
This training uses real-world case studies to enable participants to apply QRM concepts confidently to quality system challenges and manufacturing processes. Through interactive exercises, participants will gain hands-on experience in selecting suitable risk tools, performing risk assessments, and interpreting results to support sound, defensible decision-making.
Day 1 — QRM in Quality & Compliance
Quality systems rely on well-informed, evidence-based decisions. Whether addressing customer complaints, deviations, audit findings, or CAPA, a structured risk assessment process strengthens compliance and supports consistent product quality. Day 1 focuses on applying QRM tools within key GxP processes and improving the quality of compliance-related decisions.
Topics include:
- QRM framework and core concepts
- How risk supports GMP compliance and decision-making
- Applying risk assessments within key quality systems:
- Audits
- Change Control
- Complaints & Adverse Events
- Deviations & Non-conformances
- CAPA
Day 2 — QRM for Manufacturing & Process Risk
QRM has become integral to pharmaceutical manufacturing since its adoption into GMPs. Day 2 provides a practical understanding of when and how to use the right tools, ensuring risk assessments add real operational value. Participants will learn how to evaluate process risks, identify controls, and build risk-based justification for manufacturing decisions.
Topics include:
- Understanding process risks and critical factors
- Overview of GMP expectations for process risk assessments
- Selecting from the QRM toolbox: choosing the right tool for the problem
- Practical application of key tools:
- Preliminary Hazard Analysis (PHA)
- Hazard Analysis & Critical Control Points (HACCP)
- Failure Mode & Effects Analysis (FMEA)
Participants
This course is designed for both personnel new to process risk assessment as well as more experienced QRM practitioners. You will benefit from this course if you have a simple interest in or have any level of responsibility for risk assessments of quality compliance and/or manufacturing processes.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 full day sessions with breaks.
PDF Certificates will be provided to participants electronically.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
Participants will attend both full-day sessions.
| Sessions | Dates | Times |
| Day 1 | 15 April 2026 | 9:00am-5:00pm |
| Day 2 | 16 April 2026 | 9:00am-5:00pm |
Seats are limited: Only 25 participants per class
Fee
- HKD $4320 per participant
Course Registration and Payment
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Contact us to discuss your interest in a public or private delivery of this course.
