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

  • Status: Register Your Interest

  • Campus: Online

  • years: 1.5

  • Fees: €7,000* See FEES section below for funding options


Course Overview

Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing. The aim of the Level 9 Taught Graduate Diploma of Science in Process Validation and Regulatory Affairs (Medical) is to equip learners with competence in the appropriate legal, compliance and industry operational standards.

The programme will enable understanding of all current applicable regulations, quality management systems and effective process validation requirements. Learners will have the knowledge and skills to be able to audit all, or part of, organisation’s formal 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; ensuring that they will develop skills to address and prepare for the ever-changing environment of regulatory affairs in the Medical Device sector.

This Graduate Diploma of Science is delivered online and designed as an innovative multi-tiered programme to address the needs and requirements of industry-based learners and making education more accessible. It is designed so that learners can opt to select the module streams individually as Special Purpose Awards (six), complete three of the module streams to attain a Level 9 Graduate Diploma or opt for the Level 9 Masters of Science.

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






For full information on this programme please click here. Click here for all Flexible Learning Policies & Procedures Springboard+ is co-funded by the Government of Ireland and the European Social Fund as part of the ESF programme for employability, inclusion and learning 2014-2021. It is also supported by the European Year of Skills 2023.

Contact Details

General Queries

Flexible Learning Office

Email: springboard.midwest@tus.ie

Telephone: (061) 293802

Clodagh Moore

Clodagh Moore

Email: Clodagh.Moore@tus.ie

What are the entry requirements?

a) A minimum honours bachelor degree (Level 8) 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
(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three 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 6.5

or

Recognised Prior Learning (RPL): Prospective applicants who do not meet the academic entry requirements should submit their application online and then email springboard.midwest@tus.ie to request assessment via RPL.

ENGLISH LANGUAGE: Applicants who do not have English as their first language must ensure they satisfy English Language requirements. For entry to undergraduate courses, a score of 5.5 in an IELTS or equivalent exam is required. For postgraduate courses, a score of 6.5 in an IELTS or equivalent exam is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements.

Course Content

  • Quality Management

    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.

  • Regulatory Affairs (Medical)

    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.

  • Auditing and Risk Management

    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.

  • Advanced Regulatory Affairs (Medical)

    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.

  • Computer Systems Validation (Elective)

    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.

  • Advanced Process Engineering

    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.

  • Process Validation (Elective)

    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.

More Information

  • 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 may apply externally to sit the internationally recognised ISO9001:2015 Lead Auditor Exam, which equips learners 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.

  • On completing the Postgraduate Diploma, students can transfer onto the Masters in Process Validation and Regulatory Affairs to complete one 30 credit dissertation module.

  • 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.

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

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

  • This programme was Springboard+ funded in 2023. Successful applicants in employment qualified for 90% Springboard+ funding & were liable for the balance of the 10% fee of €700. Successful applicants on a qualifying DSP payment qualified for 100% funding.

  • TBC for 2024-2025 Academic Year