Product Design Control (Postgraduate Diploma, L9, 60 ECTS)

Program Overview

The Postgraduate Diploma in Product Design Control from TUS equips learners with the knowledge and skills to manage and contribute to all stages of the product design process within a regulated environment. The program emphasizes the importance of Risk Management and prepares learners for careers in sectors such as Medical Device, Pharmaceutical, and Food and Drink. Delivered online over 12 weeks per semester, assessment is continuous with no end-of-semester exams.

Program Outline

Product Design Control (Postgraduate Diploma, L9, 60 ECTS) - TUS

Degree Overview:

The Postgraduate Diploma in Product Design Control Management aims to equip learners with the competence to understand the primary concepts of product design control and the necessary skills for success in product development within a regulated environment. The program focuses on 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 stage of the design process, including:

• Design, 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 emphasizes the importance and role of Risk Management throughout the design development process. It develops learners' skills to address and prepare for the ever-changing environment of Product Design Control in sectors such as Medical Device, Pharmaceutical, Automation, Automotive, Food, and Drink.

Outline:

Semester 1:

• Quality Management: This module provides an in-depth understanding of quality and quality management, covering various definitions of quality, practical application of systems and processes to manage quality, International Standards for Quality Management, teachings of quality gurus, National and International Quality Awards, and self-assessment models.
Learners develop skills to become leaders and innovators in the application of Quality principles and techniques, preparing them for senior roles in the service and manufacturing industry.
• Product Design Control: This module provides a broad overview of product Design Control elements in the product lifecycle, covering each phase from concept to sustaining.
Learners understand that Design Control is an iterative process where the product design is continuously refined, and changes are reviewed, documented, and approved. The module emphasizes 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.
• Project Management: This module introduces formal project management methodologies and the project management environment.
Learners develop skills and knowledge in the tools and techniques documented in the Project Management Body of Knowledge (PMBOK). The module focuses on the application of these tools within industry and adopts both theoretical and active learning. Learners identify and complete an individual industry-based project, completing weekly assignments that provide experience across all areas of the PMBOK.

Semester 2:

• Product Design Verification and Validation: This module provides a broad overview of design verification and validation activities in a product's lifecycle.
It evaluates design verification and validation approaches, models, development, implementation, testing, and maintenance of a product. The importance and application of design verification and validation management, reporting, and risk management in the product lifecycle are defined and evaluated. This module advances learners' transferable skills, preparing them for industry-based employment, including creative problem-solving and technical writing.
• Product Risk Management: This module provides a fundamental understanding of product Risk Management as part of the Design Control process.
Learners gain the ability to estimate and evaluate associated risks, control the risk, and verify the effectiveness of control. They fully understand each element (Risk Management Plan, Risk (Hazard), Risk Management Report, and Design FMEA) of the Risk Management File, allowing them to develop and maintain the file throughout the Design Control process. This module develops learners' skills to work within Risk Management teams in planning, managing, and developing design failure mode analysis, ensuring safe and effective products are delivered to the customer.
• Process Design Standards & Regulatory Affairs: This module provides 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 submission pathways as they apply to medical devices, pharmaceuticals, Biopharmaceutical, and Food manufacture. This module enhances a learner's career in regulatory affairs by developing increasing levels of competence and professionalism through a formal qualification in the industry.

Course Schedule:

• Delivery: Online
• Duration: September 2024 to April 2025
• Weeks: 12 per semester
• Days/Evenings per week: 3
• Delivery Day/Evening: Monday, Tuesday, Thursday
• Hours per day/evening: 3 hours (lectures) / 1 hour (support classes)

Assessment:

• Continuous assessment (100% online): No end-of-semester exams.

Teaching:

• Delivery Method: Online
• Faculty: Clodagh Moore (Academic Queries)
• Support Classes: Optional attendance on Thursdays and Fridays

Careers:

• Potential Career Paths:
• Engineers (mechanical, reliability, human factors, software)
• Product/Project Managers
• Quality, Risk Management, and Regulatory Compliance Leaders
• Opportunities: The program prepares learners for industry-ready roles in various sectors, including Medical Device, Pharmaceutical, Automation, Automotive, Food, and Drink.

Other:

• Time Commitment: Each 5 credits equate to approximately 100 Total Learning Hours, including class time and work outside of college.
• Class Recordings: All classes are recorded and can be watched back.