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
Future course run
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
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 1 Jul 2023 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 to choose from the courses available on the Training Exchange course directory.
GST Increment in 2024
Please note that the GST rate will be revised to 9% with effect from 1 Jan 2024, as such any payable course fees will be subjected to the new GST rate adjustments in 2024.
Note:
- The fees below are determined based on prevailing funding policies and subject to review and revision.
- Please refer to our FAQs for more information.
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.
| Applicants / Eligibility | Fees |
|---|---|
| Full Course Fee | $419.65 |
| Singaporeans aged below 40 qualified for SkillsFuture Funding* | $125.90 |
| Singaporeans aged 40 & above qualified for SkillsFuture Mid-Career Enhanced Subsidy* | $48.90 |
| Singaporeans qualified for Enhanced Training Support for SMEs* | $48.90 |
| Singapore Permanent Residents & **LTVP+ qualified for SkillsFuture Funding | $125.90 |
| Singapore Permanent Residents & ##LTVP+ qualified for Enhanced Training Support for SMEs | $48.90 |
| Others (and Repeat Students) | $419.65 |