Implementing ICH Q10 Pharmaceutical Quality System

Short Course / 2.5 days

Course Information
Learning Outcomes
Course Schedule
Lesson Plan
Trainer Profile
Certification
Entry Requirements
Course Fees

Course Information

ICH Q10 Pharmaceutical Quality System is a harmonized system with emphasis on integrated approaches based on science and quality risk management. It aims to promote a paradigm shift from discrete GMP compliance procedures at each stage of the product lifecycle to a comprehensive quality system approach.

Implementation of ICH Q10 throughout the product lifecycle will facilitate innovation and support continual improvement by strengthening the links between pharmaceutical developments and manufacturing activities.

This course is suitable for persons involved in:

  • quality management
  • regulatory affairs / auditors
  • product development
  • process development
  • excipient supplies

Learning Outcomes

Course participants will be able to implement ICH Q10 Pharmaceutical Quality System using the product lifecycle approach to continually strengthen the links between pharmaceutical developments and manufacturing activities.

Course 
Schedule

Application Period: TBC
Course Date: TBC
Day & Time: 2.5 days (Wednesday – Friday), 9am to 1pm

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:

  • ICH Q10 Pharmaceutical Quality System
  • Product Life cycle approach to managing quality system
  • Relationship of ICH Q10 to GMP requirements and ISO Standards
  • Common Technical Document (CTD) for regulatory submissions
  • Post-approval Change Management
  • Continual Improvement and CAPA
  • Knowledge Management and Risk Management
  • Supplier audits and GMP inspections
  • Management Responsibility and Quality Policy & Planning

Trainer's Profile

John Lee

Mr John Lee has more than 35 years of working experience in pharmaceutical industry. He had assumed various senior positions in leading pharmaceutical companies including GSK, Baxter, Eli Lilly and Wyeth. He has many years of training and consultancy experience and is currently working as regulatory consultant.

John holds a M.Sc. degree by research from the University of Birmingham and a B.Sc. (Hons) degree in Chemistry from the University of Singapore. John also has an Advanced Certificate in Training & Development (ACTA).

Certification

A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).


Entry Requirements

Applicants with any of the following qualifications are invited to apply for the course:

Applicants should have at least 1 year of working experience in pharmaceutical or biomedical science industry

Course Fees

Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.
The course is eligible for SkillsFuture Credit. For more information on the SkillsFuture Credit click here.
For enhanced training support, enter SME in the promo code during course application.

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$192.60
Singapore Citizens (SC) aged 40 and above$72.60
Singapore Permanent Residents (PR)$192.60
Enhanced Training Support for SME Scheme (for SC & SPR)$72.60
Others (and Repeat Students)$642.00
Full Course Fee$642.00