SPECIALIST DIPLOMA IN BIOMEDICAL & PHARMACEUTICAL ENGINEERING (ALUMNI)

SPECIALIST DIPLOMA IN BIOMEDICAL & PHARMACEUTICAL ENGINEERING (ALUMNI)

About the Course

The biomedical manufacturing sector is one of the pillars of manufacturing in Singapore. This sector includes medical technology and pharmaceutical segments. According to the Ministry of Trade and Industry, it is a fast growing sector and will continue to drive manpower demand in skilled workforce to support its growth in this highly regulated sector. This sector also emphasizes on staff training and skills upgrading as required by regulations. The SkillsFuture Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering) course aims to train Professionals, Managers, Executives and Technicians (PMET) in various functions such as production, project management, quality assurance, regulatory compliance and supply chain management in biomedical manufacturing sector. The course is designed in collaboration with the industry to ensure that skillsets are relevant to employers while providing participants a seamless continuation from their discipline of study to meet a cluster of job roles in biomedical manufacturing sector. The 300-hour Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering) comprises of two 150-hour Post Diploma Certificates (PDCs):?PDC in GxP* of Operations Management (OM)?PDC in GxP of Quality Assurance & Compliance (QAC) *GxP is a general term for good practice quality guidelines and regulations. These guidelines are used in biomedical, pharmaceutical and food industries.
  • Course Aim

    The SkillsFuture Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering) aims to train participants in various functions such as production, project management, quality assurance, regulatory compliance and supply chain management and to deepen their knowledge and skills in good practices of operations management, quality assurance and regulatory compliance in biomedical manufacturing sector. It focuses on integrating knowledge with practice through case-based study in class, and self-directed eLearning. Upon completion of this Work-Study Post-Diploma, participants will be able to: Apply Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) knowledge in the manufacturing value stream of medical devices or combination products Employ Good Engineering Practice (GEP) and ?risk-based approach? in project management within biomedical industry Use productivity tools and analytical skills in process improvement and trouble-shooting Manage Corrective Action/Preventive Active (CAPA) and apply Quality Risk Assessment (QRM) in compliance to various regulatory requirements Conduct quality internal audit and comply with safety requirements, Work Safety and Health Act (WSHA) at work Integrate knowledge and practice to develop professional competencies in operations management, quality assurance and regulatory compliance within biomedical industry Apply professional competencies in GxP in related industries
  • Course Outline

    Specialist Diploma in Biomedical and Pharmaceutical Engineering (SD-BPE): PDC in GxP of Operations Management (OM) This course provides participants with an in-depth knowledge and good practices for Good Manufacturing Practice (GMP) related manufacturing activities of medical devices and combination products with chemicals or biologics. The course will use standards from US FDA and European Union as the basis for discussions in regulatory compliance pertaining to operations management. PDC in GxP of Quality Assurance & Compliance (QAC) This course provides participants with an in-depth knowledge of Good Laboratory Practice (GLP) with hands-on practices in quality control of medical devices and combination products. The course will use US FDA standards such as 21CFR Part 820 and European Union regulations specifically ISO 13485 as the basis for discussions in quality assurance and regulatory compliance pertaining to laboratory operations.
  • Target Participants

    For the Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering): Local polytechnic graduates (Singapore Citizens, Singapore Permanent Residents) within 5 years from their graduation or from their National Service Operationally Ready Date (ORD). Pre-NS enlistees may now apply to seek provisional acceptance into the programme. For Public: Fresh University or Polytechnic graduates aspiring to build a career in the Biomedical Manufacturing Sector. In-employment participants aiming to deepen their knowledge and skills for career advancement. PMET aiming to reskill and starting new careers in a fast-growing MedTech, biomedical and pharmaceutical industries. (Apprenticeship scheme with allowance available for public candidates without fulltime employment ? subjected to participating companies? interview & selection criteria)
  • Certification

    Participants will receive a Post-Diploma Certificate (PDC) upon successful completion of each semester. Participants will be awarded the?Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering) upon successful completion of both PDCs
  • Admission Requirements

    For the Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering): Local Polytechnic graduates with less than 5 years of graduation or ORD Work-&-study at WSP participating companies with salary Singapore Citizen or PR For Public: A relevant university degree or Polytechnic Diploma Applicants who do not meet the entry requirements may be considered for admission to the course based on Recognition of Prior Learning (RPL) (suitable applicants who are shortlisted may be subjected to an interview and/or entrance test. The Polytechnic reserves the right to shortlist and admit applicants)
  • Course schedule (conducting days & time)

    PDC in GxP of Quality Assurance & Compliance:Every Friday 1000 to 1700 (about 20 weeks) PDC in GxP of Operations ManagementEvery Friday 1000 to 1700 (about 20 weeks) Two intakes per academic year: Apr to Mar, Oct to Sep Conducting days and time: 10am-5pm (Fri)
  • What You'll Study

  • Key benefits of programme

    Feedbacks from graduates: ?I have moved on to a work-&-study degree course.? ?The course has made my career switch from semiconductor industry to a MedTech company seamless.? ?I received offer to study degree course from NTU.? ?I received pay increment upon graduation from the course.? ?I learnt useful skills that could be applied at work.???,etc.
  • Programme structure

    The 300-hour Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering) comprises of two 150-hour Post Diploma Certificates (PDCs):?PDC in GxP of Operations Management (OM)?PDC in GxP of Quality Assurance & Compliance (QAC) PDC in Module Code Module Name GxP of Operations Management EG131E GMP@Production EG132E GxP Project Management EG133E Computer System Validation EG134E Integrated-Work-Study Project 1 in Operations Management EG135E Integrated-Work-Study Project 2 in Operations Management Elective Module A (select 1) EG136E Process Optimisation & Operations Excellence EG137E Good Distribution Practice (GDP) & Cold Chain Management PDC in Module Module Name GxP of Quality Assurance & Compliance EG231E GLP@Laboratory EG232E Industrial Safety & WSHA EG233E CAPA & Risk Assessment EG234E Integrated-Work-Study Project 3 in Quality Assurance & Compliance EG235E Integrated-Work-Study Project 4 in Quality Assurance & Compliance Elective Module B (select 1) EG236E Regulatory Compliance & ISO 13485 EG237E Good Laboratory Practices (GLP) & ISO 17025
  • List of participating companies

    The course has received good feedbacks and supports?from the following participating comapnies: Edwards Lifesciences (Singapore) Pte. Ltd. JMS Singapore Pte. Ltd. CIBA Vision Asian Manufacturing & Logistics Pte. Ltd. Fong's Engineering & Manufacturing Pte. Ltd. Sanmina-SCI Systems Singapore Pte. Ltd. Covic Asia Pacific Pte. Ltd. Erbe Singapore Pte. Ltd., etc.
  • Course delivery methods and assessments

    Course is delivered via Face-to-face lectures &/or practical Blended learning with interactive self-directed eLearning (SDL) & case studies Applied learning?via real cases or situated case studies Situated learning by participating in group discussion & sharing of experience Group &/or individual projects, etc. Skills-Based Competency Assessments: No exam In-class assignments Quizzes Projects/presentation Practical Class performance, etc
  • Course Fees and Funding

    Full Time Diploma Graduates from the Class of 2021 and 2020 and graduates who complete their National Service in year 2021 and 2020 can sign up for one free Specialist Diploma course offered by NYP

  • Contact for course enquiries

    Ms CHONG KALLEN, kallen_chong@nyp.edu.sg, Tel No:65500485
    Mr NEO POH HOCK, neo_poh_hock@nyp.edu.sg, Tel No:65500650
    Ms ONG HUI YNG, ong_hui_yng@nyp.edu.sg, Tel No:65500652
  • Remarks

    (1) Work-Study intake online application (2) Non-Work-Study (Public) intake online application * NYP reserves the right to reschedule/cancel any course and amend the fees/info without prior notice.
  • Attachments