ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

Offered by School of Life Sciences & Chemical Technology

Short Course / 1 day / TGS-2019507781

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

Course Information

Knowledge of ICHQ7 guidance is fundamental to the pharmaceutical industries involved in the manufacture or supply of APIs or the audits of suppliers of APIs or its intermediates.

This course can also be used by companies as a basic cGMP course for staff who are new to API manufacturing in the pharmaceutical industry.

This course is suitable for:

  • Process Development Engineer
  • QC/QC Specialist
  • Quality Control Lab Analyst/Chemist
  • Production Engineer/Biotechnologist/Supervisor
  • Validation Associates
  • Internal Auditors and Regulatory Affairs Associates
  • Manufacturing associates/ technical associates of API or API intermediate manufacturing sites

Learning Outcomes

Course participants will be able to interpret the requirements in ICH Q7 guidance document, and implement of ICH Q7 effectively in workplace.

This course is suitable for:

  • Process Development Engineer
  • QC/QC Specialist
  • Quality Control Lab Analyst/Chemist
  • Production Engineer/Biotechnologist/Supervisor
  • Validation Associates
  • Internal Auditors and Regulatory Affairs Associates
  • Manufacturing associates/ technical associates of API or API intermediate manufacturing sites

Course 
Schedule

Course Date: TBC
Application Period: Please register your interest now (https://goo.gl/forms/MUpb6vVvTpz2xdzm1)
Duration: 1 day
Time: 8.30am to 5pm
Delivery Mode: Classroom
Venue: TBC

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

  • Understand when to apply ICH Q7 guidance
  • Interpret the requirements in ICH Q7 guidance document
  • Your contribution to the GMP framework within the organization
  • Perspective of an auditor/inspector of API/API intermediate manufacturing sites
  • Implement of ICH Q7 in workplace

Trainer's Profile

Agnes Lim

Ms AGNES LIM is a master trainer with over 25 years QA/RA experience. She gained the experience from her role as the QA/RA manager in GSK, Head of Quality (Contact lens) in Alcon and then Novartis Singapore (Pharmaceutical Manufacturing).

Expert in GMP compliance, she has hosted scores of regulatory inspections from different regulatory agencies ranging from local HSA, US FDA, PMDA (Japan), KFDA (Korea)  and  Eastern  European health authorities and notified body audits for ISO13485.

She is also very well versed in the quality systems, GMP guidelines and ISO guideline eg PICs, ICH guidelines, EU GMP, ISO 13485 and ISO 14971. She is an ISO 9001 and ISO13485 auditor, has been a lead auditor in her former companies and has led and performed numerous internal and external audits.

Certification

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


Entry Requirements

Knowledge of ICHQ7 guidance is fundamental to the pharmaceutical industries involved in the manufacture or supply of APIs or the audits of suppliers of APIs or its intermediates. This course can also be used by companies as a basic cGMP course for staff who are new to API manufacturing in the pharmaceutical industry.

Course Fees

Funding period for this course is from 5 Mar 2019 to 30 Sep 2024.

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 (www.skillsfuture.sg/credit) to choose from the courses available on the Training Exchange course directory.

Enhanced training support for SMEs
For enhanced training support for SMEs, enter SME in the promo code during course application.

Long Term Visit Pass Plus (LTVP+) Holders
Please furnish the following documents to the course administrator to qualify for SSG funding:
Self-sponsored learner (**LTVP+): Copy of your green visit pass card, with the word ‘PLUS’ on the back of the card.
Co-sponsored learner (##LTVP+): Copy of valid and current Letter of Consent (LOC) from MOM

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 Fee$411.95
Singaporeans aged below 40, Permanent Residents & **LTVP+ qualified for SkillsFuture Funding$123.59
Singaporeans aged 40 & above qualified for SkillsFuture Mid-Career Enhanced Subsidy$46.59
Singaporeans, Permanent Residents & ##LTVP+ qualified for Enhanced Training Support for SMEs$46.59
Others (and Repeat Students)$411.95