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
Monday, 9:00 am to 5:00 pm
Date: X to X 2020
Time: 9am to 5pm
Lesson Plan
This course consists of 1 modules:
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
A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).
Course Fees
| Applicants / Eligibility | Fees |
|---|---|
| Singapore Citizens (SC) below the age of 40 years | $123.58 |
| Singapore Citizens (SC) aged 40 and above | $46.59 |
| Singapore Permanent Residents (PR) | $123.58 |
| Enhanced Training Support for SME Scheme (for SC & SPR) | $46.59 |
| Others (and Repeat Students) | $411.95 |
| Full Course Fee (Before GST) | $385.00 |