Program Overview
The MSc in Product Design Control is a one-year program designed to equip learners with the skills and knowledge necessary to excel in product development within regulated environments. The program focuses on the concepts of product design control and emphasizes the importance of intended use, user needs, design input, design verification, design validation, and design transfer. Graduates are equipped to work in regulatory affairs, quality, engineering, and science environments in various industries. The program is designed in conjunction with industry, and work placement opportunities may be available subject to availability.
Program Outline
Degree Overview:
The MSc in Product Design Control is a one-year, full-time postgraduate program designed to equip learners with the skills and knowledge necessary to excel in product development within regulated environments. The program focuses on the ever-changing landscape of Product Design Control in industries such as Medical Devices, Pharmaceuticals, Automation, Automotive, Food, and Drink. The program aims to provide learners with the competence to understand the primary concepts of product design control and the necessary skills to succeed in product development in a regulated environment. It emphasizes the importance of intended use, user needs, design input, design verification, design validation, and design transfer. Learners will gain the knowledge and skills to manage and contribute to each design stage, including:
- Development planning
- Identifying design inputs
- Developing design outputs
- Verifying that design outputs meet design inputs
- Validating the design output meets user needs
- Reviewing and approving design changes
- Participating in design reviews
- Writing and approving design verification/validation plans, protocols, and reports
- Transferring the design to production
- Maintaining the product while meeting quality and regulatory standards The program also emphasizes the importance and role of Risk Management throughout the design development process.
Outline:
The program is structured over two semesters, with a total of 14 hours of instruction per week.
Semester 1:
- Product Design Control (10 Credits): This module covers the importance of achieving user needs and the linkage between each stage of the Design Control process, including Design Input, Design History File, Design and Development Planning, Product Risk Management, Human Factors and Usability Engineering, Design Review, Design Output, Design Validation/Verification, Design Change, and Design Transfer.
- Quality Management (10 Credits): This module draws from International Standards for Quality Management, teachings of various quality gurus, National and International Quality Awards, and self-assessment models. Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques, developing as quality management professionals in the service and manufacturing industry.
- Project Management (10 Credits): This module introduces formal project management methodologies and the project management environment. Learners will develop skills and knowledge in the tools and techniques documented in the Project Management Body of Knowledge (PMBOK). The module also adopts theoretical and active learning, as the learner will be required to identify and complete an individual industry-based project.
- Dissertation (Year-Long Module, 30 Credits): This module focuses on preparing a research proposal and applying the findings from the literature review to the design, testing, and execution of an in-depth research study. It emphasizes interpretation, reporting of findings, and formulating justified conclusions that address the research's original aims and objectives.
Semester 2:
- Process Design Standards and Regulatory Affairs (10 Credits): This module provides learners with a fundamental understanding of EU and international regulatory systems required during process design. It covers the role of regulatory affairs, classification, regulatory structure, and the impact of various regulated industry submission pathways, such as medical devices, pharmaceuticals, biopharmaceuticals, and Food manufacturers.
- Design Verification and Validation (10 Credits): This module evaluates design verification and validation approaches, models, development, implementation, testing, and maintenance of a product. It defines and evaluates the importance and application of design verification and validation management, reporting, and risk management in the product lifecycle.
- Product Risk Management (10 Credits): This module equips learners with the ability to estimate and evaluate associated risks, control the risk, verify the control's effectiveness, and understand each element of risk management. Learners will work within risk management teams in planning, managing, and developing design failure mode analysis, ensuring that safe and effective products are delivered to the customer.
- Dissertation (Year-Long Module, 30 Credits): This module focuses on preparing a research proposal and applying the findings from the literature review to the design, testing, and execution of an in-depth research study.
Careers:
The program is designed to enhance a learner's career in manufacturing, R&D, and regulated companies by developing increasing levels of competence, professionalism, critical thinking, problem-solving, and decision-making skills necessary to work in the regulated industry. Graduates are equipped to work in regulatory affairs, quality, engineering, and science environments. Potential roles include:
- Product Design Control
- Design Control
- Product Risk Management
- R&D Engineer
- Design Assurance Engineer
- Product Manager
- Regulatory Engineer
- Validation Engineer
- Quality Engineers
- Quality Control
- Quality Management
- Regulatory Affairs Management
- Project Engineer
- Product Management
- Process Engineer
Other:
The program is designed in conjunction with industry, and various companies may provide work placement for students on the program (subject to availability). The work placement is optional and not a mandatory requirement for students to take up. The program runs over 2.5 days, with students attending classes two to three days a week. The remaining four hours of instruction are delivered online on Monday.
