Specialist Diploma in Biomedical and Pharmaceutical Engineering

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.

This Part-time 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.

This Specialist Diploma is offered in two modes: (a) Day Class, (b) Evening Class.

The 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 Aims

This course aims to train learners in various functions such as Quality Assurance Officer, Operation Technician, Quality Control Technician, GMP Trainer, Product Specialist, Regulatory Associate, Assistant Validation Engineer, Production Supervisor, Technical Trainer, Trainee Technical Specialist, Lab Analyst, etc. in good practices of operations management, quality assurance and regulatory compliance in biomedical manufacturing sector.

Upon completion of both PDC in GxP of Operations Management & PDC in GxP of Quality Assurance and Compliance, participants will be able to:

(a) Apply current Good Manufacturing Practice (cGMP) and Good Distribution Practice (GDP) in production operations and supply chain of medical devices or combination products according to regulatory requirements;

(b) Implement Good Engineering Practice (GEP) and Good Automated Manufacturing Practice (GAMP) and “risk-based approach” to design, plan, execute, control, validate and review a project using industry best practices;

(c) Manage various productivity and analytical tools in operational excellence in compliance to regulatory requirements;

(d) Apply Good Laboratory Practices (GLP) in laboratory management in compliance to regulatory requirements;

(e) Evaluate Corrective Action/Preventive Active (CAPA) and Quality Risk Assessment (QRM) in compliance to regulatory requirements;

(f) Manage internal quality audit according to regulatory requirements at workplace.
Target Participants
This course is suitable for:
- 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)

What You'll Study

Post Diploma Certiﬁcate in GxP of Operations Management

GMP@Production [30 hours]

Good Manufacturing Practices (GMP) are important to ensure products consumed by patients are produced according to strict regulatory requirements. Learners will be equipped with an in-depth current Good Manufacturing Practice (cGMP) knowledge in the production of medical devices and combination products. Learners will deepen skills in cGMP applications by interpreting and applying regulation guidelines from Singapore, USA or European Union (EU) in addressing warning letters from regulatory agencies or nonconformance records at workplace. Learners will be able to apply validation skills at a GMP-compliant facility.

GxP Project Management [15 hours]

GxP is a term for good practice quality guidelines and regulations used in medical devices, biologics, pharmaceutical and food industries. Learners will learn major processes, tools and techniques used to design, plan, execute, control, validate and review a project to meet project objectives and its intended purpose. Learner will be able to apply GxP project life cycle management tools from concept study phase to validation completion according to regulatory requirements.

Computer System Validation [15 hours]

Data integrity and compliance with current Good Manufacturing Practice (cGMP) are critical to ensure regulatory compliance, product quality and patient safety in biomedical and healthcare industries. In this module, learner will learn the Computer System Validation (CSV) approach in meeting regulatory requirements. They will learn Good Automated Manufacturing Practice (GAMP) and interpret the guidelines under USA FDA and EU Annex 11 for computerized systems. Learners will use workplace case studies to deepen knowledge and skills in CSV.

Integrated-Work-Study Project in Operations Management [30 hours]

In this Integrated-Work-Study Project (IWSP) module, learners will be able to integrate the knowledge and skills they have acquired from the course to develop solutions for workplace problems or real-life applications in operations management. IWSP is delivered via On-The-Job (OJT) at learners’ workplace. IWSP allows learners to integrate theory and practice to develop deep specific professional competencies in their career field, which may lead towards professional advancement. Option is available for public mode learners to complete this module via in-house project with scope relevant to real work problems or applications in operations management.

Process Optimisation & Operations Excellence [15 hours]

Operations personnel need to deal with challenges and opportunities in complex manufacturing activities. In this module, learners will learn various productivity tools and the principles of lean manufacturing in waste elimination and value stream management. They will be able to use productivity tools for process improvement to reduce or eliminate resource wastage using commercial-of-the-shelf software.

Good Distribution Practice (GDP) & Cold Chain Management (CCM) [15 hours]

Effective Supply chain management is critical to ensure effective supply of safe and quality products to patients. In this module, learners will learn the principles of Good Distribution Practice (GDP) and Cold Chain Management (CCM) for biomedical and healthcare industries. Learners will be able to interpret the requirements of GDP and CCM compliance by Singapore Health Sciences Authority in relation to the storage and distribution of biomedical and healthcare products for human use.

Elective Module (Select Two):

GMP Audit Management [15 hours]

In this Project-Based Learning (PBL) module, learners will be able to gain knowledge and skills by working for an extended period to investigate and respond to an engaging and complex question or problem in the context of current Good Manufacturing Practice (cGMP) audits at workplace. Learners will apply and assimilate the knowledge and skills acquired in the course to practise the role of GMP auditor or Quality Assurance Lead in a project scope provided by school. This module will prepare learners holistically in both technical and critical core skills to solve real work problems in cGMP related activities.

Automated Process Design [15 hours]

In this Project-Based Learning (PBL) module, learners will be able to gain knowledge and skills by working for an extended period to investigate and respond to an engaging and complex question or problem in the context of automated process design at biomedical manufacturing facilities. Learners will apply and assimilate the knowledge and skills acquired in the course to practise the role of process or automation engineer in a project scope provided by school. This module will prepare learners holistically in both technical and critical core skills to execute real work projects in ensuring regulatory compliance while implementing digitalization or automation at workplace.

Cold Chain Validation [15 hours]

In this Project-Based Learning (PBL) module, learners will be able to gain knowledge and skills by working for an extended period to investigate and respond to an engaging and complex question or problem in the context of a supply chain involving biomedical products. Learners will apply and assimilate the knowledge and skills acquired in the course to practise the role of validation engineer or Quality Assurance Lead in a project scope provided by school. This module will prepare learners holistically in both technical and critical core skills to plan a cold chain validation in a real world setting while ensuring compliance to relevant regulatory requirements.

Post Diploma Certiﬁcate in GxP of Quality Assurance & Compliance

GLP@Laboratory [30 hours]

Laboratory management including personnel, instrument, materials, contract services and documentation in compliance to various regulatory guidelines is paramount for product quality and patients’ safety in biomedical and healthcare industries. In this module, learners will interpret Good Laboratory Practice (GLP) guidelines. They will be equipped with skillsets to support analytical methodology transfer and validation. Learners will practise GLP applications using workplace case studies.

Industrial Safety & WSHA [15 hours]

The safe operation of workplace that focuses on biomedical manufacturing or laboratory research is complex. In this module, learners will be equipped with knowledge and skillsets to assess and control risk at workplace in compliance to Singapore Workplace Safety and Health Act (WSHA). Learners will use case studies relevant to biomedical and healthcare industries to integrate theory and practice in industrial safety and compliance to WSHA.

CAPA & Risk Assessment [15 hours]

Corrective Action & Preventive Action (CAPA) is one of the elements included in an integrated risk management process within the quality management system of biomedical and healthcare industries. In this module, learners will learn the procedure in handling CAPA and, the principles and process of Quality Risk Management (QRM). Learners will be equipped with useful tools in handling CAPA and problem-solving according to regulatory requirements. They will be able to analyse cases reported by regulatory bodies to deepen their skills in knowledge applications.

Integrated-Work-Study Project in Quality Assurance & Compliance [30 hours]

In this Integrated-Work-Study Project (IWSP) module, learners will be able to integrate the knowledge and practise the skills they have acquired from the course to develop solutions for workplace problems or real-life applications in quality assurance & compliance. IWSP is delivered via On-The-Job (OJT) at learners’ workplace. IWSP allows learners to integrate theory and practice to develop deep specific professional competencies in their career field, which may lead towards professional advancement. Option is available for public mode learners to complete this module via in-house project with scope relevant to real work problems or applications in quality assurance & compliance.

Regulatory Compliance & ISO 13485 [15 hours]

There are various regulatory standards such as ISO 13485 specify the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet quality specifications. In this module, learners will learn how to interpret the requirements of ISO 13485, USA FDA 21CFR Part 820 and relevant EU regulations that covers regulatory controls at three key stages of the product life cycle of a medical device: pre-market, placing-on market, and post-market.

Lab Management & ISO 17025 [15 hours]

There are various international quality standards or regulatory guidelines on laboratory management. An effective laboratory management will ensure product quality and patient’s safety. In this module, learners will learn how to interpret USA FDA regulations and EU standard, ISO 17025 of testing laboratories for compliance. Learners will be able to analyse real world problems in the context of a testing lab environment according to ISO 17025 guidelines.

Elective Module (Select Two):

Quality Risk Management [15 hours]

In this Project-Based Learning (PBL) module, learners will be able to gain knowledge and skills by working for an extended period to investigate and respond to an engaging and complex question or problem in the context of Quality Risk management (QRM) throughout the whole supply chain of GMP-related products or activities. Learners will apply and assimilate the knowledge and skills acquired in the course to practise various roles in quality function with a project scope provided by school. This module will prepare learners holistically in both technical and critical core skills to identify, eliminate or control risks and Implement measures to reduce or eliminate potential risks in operations in compliance to regulatory guidelines.

Medical Device Design & Validation [15 hours]

In this Project-Based Learning (PBL) module, learners will be able to gain knowledge and skills by working for an extended period to investigate and respond to an engaging and complex question or problem in the context of medical device design and validation activities. Learners will apply and assimilate the knowledge and skills acquired in the course to practise the role of validation engineer or Quality Assurance Lead in a project scope provided by school. This module will prepare learners in both technical and critical core skills to conduct design inputs/outputs review, verification & validation of medical device in compliance to regulatory guidelines.

GLP Audit Management [15 hours]

In this Project-Based Learning (PBL) module, learners will be able to gain knowledge and skills by working for an extended period to investigate and respond to an engaging and complex question or problem in the context of Good Laboratory Practices (GLP) audit management at a quality control lab. Learners will apply and assimilate the knowledge and skills acquired in the course to practise a role of GLP auditor or auditee with a project scope provided by school. This module will prepare learners holistically in both technical and critical core skills to establish audit processes and procedures to ensure GLP audit management system are effectively implemented for continuous improvement at workplace.

Specialist Diploma in Biomedical and Pharmaceutical Engineering

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