ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

Short Course / 1 day

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: TBC

Duration: 1 day

Time: 8.30am to 5pm

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:

  • 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

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

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

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
Full Course Fee$411.95
Singaporeans and Permanent Residents$123.59
Singaporeans qualified for SkillsFuture Mid-Career Enhanced Subsidy$46.59
Singaporeans and Permanent Residents qualified for Enhanced Training Support for SMEs$46.59