Quality Risk Management in the Pharmaceutical Industry

Short Course / 1 day

Course Information
Learning Outcomes
Course Schedule
Lesson Plan
Certification
Course Fees

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

Application Period: TBC
Course Date: TBC
Duration: 1 day
Time: 8.30am to 5.30pm
Venue: Ngee Ann Polytechnic

Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.

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

Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.

Union Training Assistance Programme (UTAP)
NTUC members enjoy 50% unfunded course fee support for up to $250 each year (or up to $500 for NTUC members aged 40 years old and above) when you sign up for courses supported under UTAP (Union Training Assistance Programme). Please visit e2i’s website to find out more.

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