Product Design Control - Online

The majority of companies today operate in changeable industries adapting to customer needs, promoting innovation, regulatory requirements and staying competitive. Due to these challenges products, today are continually changing e.g. make it lighter, smaller, faster, smarter. This has increased the demand for people working in product development such as engineers (mechanical, reliability, human factors, software), product/project managers, quality, risk management and regulatory compliance leaders. The aim of the Level 9 Graduate Diploma in Product Design Control Management is to equip learners with competence to learn the primary concepts of product design control as well as the necessary things needed in order to be successful in product development in a regulated environment. Particular focus on intended use, user needs, design input, design verification, design validation and design transfer. Learners will have the knowledge and skills to be able to manage and contribute to each stage of the design, development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design output meets the user needs, review and approving design changes, participating in design reviews, writing and approving design verification/validation plans, protocols and reports and finally transferring the design to production, maintain the product while meeting quality and regulatory standards. While also understanding the importance and role of Risk Management through each stage of the design development process. The programme will develop the 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.

Critical thinking, problem-solving, decision-making, professionalism, and management techniques will be key areas covered by the programme.

As assessments will be mainly industry-based, learners are required to engage with industry and industry representatives in various cross disciples through continuous assessment and industry-based projects. This will prepare learners to be industry ready and apply the transferable skills gained through module content, industry engagement, and strengthened by industry-based assessments.

What will the time commitment be?
Each 5 credits will normally equate to approximately 100 Total Learning Hours. Total Learning Hours includes the time you spend in class (lectures, tutorials, practical elements) and the time you spend completing work outside of college. The balance between these two varies by discipline, and by level of study. You should bear in mind that the workload will increase at particular times e.g. when assignments are due.

What modules will I study?
Product Risk Management: Aims to provide learners with a fundamental understanding of product Risk Management as part of the Design Control process. The module will give the learner the ability to estimate and evaluate associated risks, controlling the risk, and verifying the effectiveness of control. The learner will fully understand each element (Risk Management Plan, Risk (Hazard), Risk Management Report, and Design FMEA) of the Risk Management File which allows them to develop and maintain the file throughout the Design Control process. This module will help the student develop a number of Professional Transferable Skills, such as working within Risk Management teams in planning, managing and development of design failure mode analysis ensuring that safe and effective products are delivered to the customer.

Product Design Control: Module aims to provide the learner with a broad overview of product Design Control elements in the product lifecycle. Covering each phase from concept through to sustaining. The learner will understand that the Design Control is an iterative process, throughout which the product design is continuously refined and changes are reviewed, documented, and approved. Through this understanding the learner will understand the importance of achieving the user needs and the linkage between each stage of the Design Control process from 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. This module will help the student develop a number of Professional Transferable Skills, such as working within teams in planning, managing and execution of design projects with the ability to be customer focused.

Project Management: Module will introduced formal project management methodologies and the project management environment. Learners skills and knowledge will be developed in the tools and techniques that are documented in the Project Management Body of Knowledge (PMBOK). A significant focus of the module will be on the application of these tools within industry.The module also adopts both theoretical and active learning, as the learner will be required to identify and complete an individual industry-based project. They will complete a set of weekly assignments on their chosen project which, when combined, will give them experience across all of the areas of the PMBOK. They will be fully encouraged to apply theory and analytical tools practically within their industry-based project.

Process Design Standards & Regulatory Affairs: Aims to provide learners with a fundamental understanding of EU and international regulatory systems required during process design. The module will cover 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 will enhance a learner's career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in industry.

Product Design Verification and Validation: The aim of the Design Verification and Validation module is to provide the learner with a broad overview of design verification and validation activities in a product's lifecycle. To evaluate 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 will be defined and evaluated. This module aims to advance the learner's transferrable skills, in order to prepare them for industry-based employment, including creative problem-solving, and technical writing.

Quality Management: will facilitate an in-depth understanding of quality and quality management, from the various definitions of quality, through to the practical application of systems and processes to manage quality. The module will draw from International Standards for Quality Management, the teachings of the various quality Gurus, National and International Quality Awards, and self assessments models. This module will help the student develop a number of Professional Transferable Skills, such as leadership, strategic direction, system approach, PDCA, and customer focus. Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

What are the entry requirements?
(a) A minimum honours bachelor degree (Level 8) in any discipline.
Or
(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work-based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning
Or
(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.0.

(d) Recognised Prior Learning (RPL) / Special Case Registrations: Prospective participants who do not meet the entry requirements for the programme detailed above, but who may qualify for admission by meeting certain other equivalent criteria, should notify the Flexible Learning Office and request consideration under RPL. Please submit your application online and then email all your supporting documents to Springboard@lit.ie

Application Deadline August 29th 2021

9 months

Delivery
This programme will run online from September 2021 to June 2022

Semester 1 Timetable:

Regulatory Affairs - Tuesdays from 7pm to 10 pm
Product design control - Wednesdays from 7pm to 10 pm
Quality Management- Thursdays from 6:30pm to 9:30 pm

Class recordings: All classes will be recorded and can be watched back

Location: Online

Are there opportunities for further study?
Graduates from the programme can progress on to the Masters in Product Design Control. Where they will be required to complete the one Dissertation Module.

What are the career prospects?
There are multiple roles a graduate from the programme can seek in disciplines such as Quality Engineering, Management, Auditing, Compliance, Legal and Regulatory affairs.

Furthermore, there are multiple roles a graduate from the programme can seek in areas such as Design manager ,Product Design Control, Product Risk Management, R&D Engineer, Design assurance Engineer, Product Manager, Regulatory Engineer, Process Engineer, Validation Engineer, Quality Engineers, Regulatory affairs Management, Process Engineering Management, Validation Management, Quality Management, Quality Management Systems, Quality Assurance, Compliance and Auditing Management, Risk Management.