The SGUS-MPT is a full-time course focusing on providing learners with skills and competencies for employment in the Biomedical Science and related areas. The course will be of particular value for persons seeking employment in biomedical manufacturing and bioanalytical services; including manufacturing of pharmaceuticals, biopharmaceuticals, medical supplies, medical devices and diagnostic devices and employment in diagnostic laboratories; for example, testing for COVID-19 and other infectious diseases.
The programme will equip trainees with essential skills and competencies for employment in pharmaceutical, biopharmaceutical, and medical device manufacturing and in bioanalytical and diagnostic services.
Trainees will learn and apply concepts in areas of molecular biology, microbiology, statistical data analysis, current Good Manufacturing Practices, quality control, quality assurance and documentation, upstream and downstream processing for biopharmaceutical manufacturing, drug formulation and pharmaceutical analysis.
This programme places a strong emphasis on laboratory practical training to provide hands-on skills for participants.
Course Start Date: 1 Jul 2021 – 31 Dec 2021
Application Period: TBC
Course Duration: 6 months
Schedule: Minimum of 60 hours per month
Practicals will be conducted in Ngee Ann Polytechnic, and lectures will be conducted online
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.
This course consists of 10 modules:
The module will provide an introduction to basic cell & molecular biology concepts. It equips students with an understanding of cell biology, including structure and function of cells and its organelles, cellular transport mechanisms, cell divisions, DNA replication, central dogma of biology, basic genetic principles, and cell development.
The module will cover the scope of microbiology including the types, classification and properties of bacteria, fungi and viruses. The laboratory sessions will equip students with essential skills in microbiology including aseptic technique, staining methods and methods for enumeration, culturing, maintenance and identification of microorganisms.
The module will cover standard methods in pharmaceutical microbiology including microbiological testing of non-sterile and sterile products, preservative testing, sterilization techniques, validation of the sterilization process, environmental monitoring and viral testing and clearance.
This short course seeks to equip participants with the ability to select and apply the correct statistical tools for the job at hand. Participants can experience hands-on practice sessions that focus on data collection, analysis, and interpretation using statistical tools of Microsoft Excel and SPSS.
The module will provide an overview of the GXP regulatory standards and requirements in the pharmaceutical industry and starting with the drug development process to the production of the finished product. This module will also provide participants with understanding of ISO 13485:2016, which provides guidance enabling medical device manufacturers to develop a quality management system for ensuring the quality, safety and effectiveness of medical devices.
The module will cover analytical techniques used for the detection, identification and quantitative determination of drugs and related substances. Techniques for the evaluation of analytical data and validation of analytical methods will be introduced as well as an overview of QC issues and regulatory requirements related to the quality of biopharmaceuticals.
The module will cover documentation and its role in Quality Assurance in pharmaceutical manufacturing. Documentation requirements under GMP, ISO Quality Management System and ICH guidelines will be compared. International quality and regulatory requirements including those of the HSA will be compared. The module will cover documentation requirements for quality events including customer complaints, out of specifications, deviation investigations, root cause analysis and corrective action preventative action. The module will also cover quality audits, regulatory inspections and interpreting and responding to FDA 483 warning letters.
The module will provide an overview of the processes involved in producing biopharmaceuticals from raw materials, using cells as biocatalysts, applications of recombinant technology, cell banking, bioreactors, bioreactor operation and factors involved in the scale up of animal cell cultures from flask to reactor. Practical sessions will include the methods of enumerating cell populations and the operation of laboratory scale bioreactors.
The module will cover the purification of recombinant proteins. Topics will include large scale cell separation and affinity, ion exchange and gel filtration chromatography. Issues relating to the packing of columns and the selection of column packings will also be covered.
The module will focus on the design and formulation of two-phase pharmaceutical products, including suspensions, emulsions and solid pharmaceutical products, particularly as they relate to the formation of sterile drugs. Topics include drug formulations, processing of sterile drug formulations, preparation of pharmaceuticals, specialized dosage forms, GMP and Validation.
Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all assessments.
Polytechnic Diploma or University Degree.
Applicants not meeting the minimum entry requirements may be considered on a case-by-case basis, based on recognition of prior learning or relevant working experience.
Trainees must fulfil minimum attendance requirements and pass assessments to qualify for course fee subsidies. Trainees who are unable to meet these requirements may be asked to return the course fee subsidies that they have received.
Full Course Fees: (including GST) $7,688
|Applicants / Eligibility||Fees|
|Singaporeans & Permanent Residents (incl. GST)||$500.00|