Process Validation and Regulatory Affairs (Medical, L9, 60 ECTS)

The aim of this module is to 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. Learners will be equipped with the knowledge and skills to be able audit all, or part of, organisation’s formal Quality Management systems against defined criteria such as ISO 13485, ISO 9001 or 21 CFR Part 820. 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.

Provide learners with an understanding of EU regulatory systems in the medical device field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the EU market. This module will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. 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 the medical device regulation industry.

Learners will gain an in-depth understanding of the application of Risk Management within organisational Quality Management Systems. Learners will acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes. There will also be a focus on managing external audits by second and third parties (customers and regulators/notified bodies). 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.

Understanding of the utilisation of standards, FDA and other jurisdictions’ guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the world market.

An overview of software validation in a manufacturing or software environment. The focus will be on software validation in a manufacturing or software environment. To evaluate software validation approaches, models, development, implementation, testing and maintenance of validated software. The importance and application of validation management, reporting and risk management in a manufacturing/software environment will be defined and evaluated.

The aim of this modules is to provide the learner with a knowledge of process engineering management in a manufacturing environment. A learner will be able to evaluate process types, designs, layouts, process analysis, forecasting of product, capacity planning while ascertaining a knowledge of current technologies and automation used in the manufacturing.

Provide the learner with an overview of process and product validation in manufacturing environments. The focus will be on Process validation with emphases on the tools and techniques that are used in the operations and manufacturing environment; to ensuring that operations are efficient in terms of using as few resources as needed, compliance with regulatory requirements and be effective in terms of meeting customer requirements.

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 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.

International Opportunities:

The content of the modules will be seen to reflect a globalised environment .This is demonstrated by the regulatory affairs module stream which focuses on EU, US and worldwide regulatory affair bodies.

This is further demonstrated through the quality management module stream as learners will receive internationally recognised award in ISO9001:2015 Lead Auditor, which equips learner to be lead auditors world-wide. Thus will be equipped with the knowledge and skills to be able audit all, or part of, organisation’s formal Quality Management systems against defined criteria such as international standards ISO 13485, ISO 9001 or 21 CFR Part 820.

Delivery

• Number of Weeks: 12 per semester
• Number of Days / Evenings per week: 3
• Number of Hours per week:  8
• Delivery Day / Evening: see below

Semester 1: September ’23 – December ’23 –  Wed & Thu 7pm – 10pm / Fri 2pm – 4pm

Semester 2: January ’24 – April ’24 – Mon & Wed 7pm – 10pm / Fri 2pm – 3pm & 4pm – 5pm

Semester 3: September ’24 – December ’24 – Mon & Thu 7pm – 10pm / Fri 3pm – 4pm & elective (either 4pm – 5pm or 5pm – 6pm)

Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.

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.

As assessments will be 100% Continuous Assessment and 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.

Students will be assessed on their learning by a variety of strategies including:

• The use of continuous assessment through projects, coursework, multiple choice questions, e-tivities, presentations and assignments. 100% Continuous assessment i.e.. NO terminal examinations.

Postgraduate Diploma in Science in Process Validation and Regulatory Affairs – Medical (Level 9, 60 ECTS)

The total fee for this programme is €7,000. This programme is funded by the National Training Fund under Human Capital Iniatitive Pillar 1 and all successful applicants will receive 90% funding for employed applicants and 100% funding for unemployed applicants.

The 10% fee to be paid will be €700 for all successful employed applicants.

Please see www.springboardcourses.ie for eligibility criteria details.

TBC