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
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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
Certification
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
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.
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 |