Course Information
Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect QRM to be inherently built into the backbone of the Quality Management System (QMS) by using a product lifecycle approach to implement risk management tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.
This course is suitable for persons involved in:
- Process Development Engineer
- QC/QC Specialist
- Quality Control Lab Analyst/Chemist
- Production Engineer/Biotechnologist/Supervisor
- Manufacturing Associates
- Internal Auditors
- Regulatory Affairs Associates
Those with limited quality risk management experience who wish to better understand the science and risk-based principles covered in ICH Q9 will also benefit from this course.
Learning Outcomes
- The regulatory drivers for QRM
- Process of quality risk management
- Principles of QRM as defined in ICH Q9
- Common tools of QRM
- The importance of QRM documentation and Risk Registers
Course
Schedule
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Course Date: TBC
Application Period:TBC
Duration: 1 day
Time: 8.30am to 5.30pm
Delivery Mode: Classroom
Venue: Ngee Ann Polytechnic
This course may be conducted online subject to Covid-19 guidelines.
Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.
Lesson Plan
Course participants will be able to implement risk management tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.
Certification
Certification
A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).
Entry Requirements
Course Fees
SkillsFuture Credit
All Singaporeans aged 25 and above can use their $500 SkillsFuture Credit from the government to pay for a wide range of approved skills-related courses. Visit the SkillsFuture Credit website to choose from the courses available on the Training Exchange course directory.
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.
(Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.)
| Applicants / Eligibility | Fees |
|---|---|
| Full course fees | $411.95 |