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: 01 Feb 2021 to 6 March 2021_x000D_
Course Date: 25 March 2021 and 27 March 2021_x000D_
Time: 25 – 26 March 2021, 9am to 5pm_x000D_
27 March 2021, 9am to 1pm_x000D_
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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:
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- 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
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Trainer's Profile
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 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._x000D_
The course is eligible for SkillsFuture Credit. For more information on the SkillsFuture Credit click here._x000D_
For enhanced training support, enter SME in the promo code during course application.
| 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 |