Quality Management and Regulatory Systems (2 Credit Hours)
COURSE DATE: 25 SEPTEMBER 2024
Laboratories and manufacturing facilities operate under strict regulatory environments to produce reliable, safe and accurate results. Adoption of the quality management system (QMS) in compliance with regulatory systems is crucial in achieving these goals. QMS is a formalised system that documents processes, procedures and responsibilities for achieving quality policies and objectives to meet the customer requirements and their satisfaction. Therefore, knowledge in QMS and regulatory systems is essential in industries and approved laboratories in improving their quality management systems. The micro – credential course in Quality Management and Regulatory Systems provides learners with the foundation in this topic and is suitable for beginners with minimal knowledge in this area.
The micro – credential course will be delivered as 100% online via asynchronous mode so t hat learners can access the course anytime from anywhere. Learners who successfully complete this micro – credential course is eligible to receive credit for, or exemption into the IMU MSc in Analytical and Pharmaceutical Chemistry programme .
Mode of Delivery / Credit Hours
- Synchronous = 0 ( %)
Asynchronous = 100 ( %)
- Credit Hours: 2
- Evaluate, criticise and defend appropriate regulatory guidelines in industries
- Evaluate, criticise and defend the processes in quality management systems
- Quality Management Systems
- Six Sigma Approaches
- Quality Systems and Risk Management Approaches
- Equipment Qualification
- Standard Operating Procedures
- Calibration and Verification
- Process Protocols
- Quality Audits
- Undergraduate students, fresh graduates, young professionals
- Dr Irene See
R&D Associate at Reckitt (Thailand)
Dr Irene See is an experienced researcher with almost 3 years of working experience in natural product manufacturing industry and 8 years of research experience in natural product chemistry field. Her past working experience include s conducting in – house manufacturing training to ground staffs, product training to both overseas and local customers in various languages, designing and setting up l ab and GMP manufacturing facility and follow through with conducting research and manufacturing the end product. Dr Irene is currently working at Reckitt (Thailand) as R&D Associate, where she involves in research and development of medical devices product .
- Dr Tan Poh Lee
R&D manager at Furley Bioextracts Sdn Bhd
Dr Tan Poh Lee has more than 10 years of industry experience in the area of research & development (R&D) at Furley Bioextracts Sdn Bhd. She is currently the R&D manager at the company. Furley Bioextracts is a recognised industry leader of Biotechnology in Malaysia. Dr Tan leads the R&D team in tasks which include creating customised testing, product development, produc t prototyping, process optimisation and regulatory affairs.
REGISTRATION FEE (inclusive of SST)
|General / Public||RM1600|
|Students & Alumni||RM1200|