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Process Validation and Regulatory Affairs - MSc

Status:


Level

9

Duration

1 Year

Department

Mechanical & Automobile Engineering


Start Date

04/09/2023

Course Type

Postgraduate Taught courses

Location

Limerick

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 Masters of Science in Process Validation and Regulatory Affairs 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. 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 learners will develop skills to address and prepare for the ever-changing environment of regulatory affairs in medical device, pharmaceutical and food and drink sectors.

What are the entry requirements?

A minimum honours bachelor degree (Level 8) in any discipline, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.

Or

A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.

Or

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. Applicants may be required to attend TUS for an interview. Zoom interviews may be arranged for international students.

Who can I contact?

What modules will I study?

  • Semester 1

    Title: Advanced Process Engineering

    Credits: 10

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    This module provides the student with the skills in areas such as entity modelling, normalisation and database design. In addition, significant time will be devoted to utilising the SQL language to operationalise the output of the design process, manage data and manage security in a modern relational database management system.


    Title: Process Validation

    Credits: 10

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    The aim of this module is to provide the learner with a broad overview of process and product validation in a manufacturing environment. To evaluate process validation approaches, models, development, implementation, testing and maintenance of a validated process and product. The importance and application of validation management, reporting and risk management in a manufacturing environment will be defined and evaluated.

    This module will help the student develop a number of Professional Transferable Skills, such as critical thinking, problem solving, innovation, and customer focus.


    Title: Quality Management

    Credits: 10

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    This module 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.


    Title: Regulatory Affairs (Food and Drink):

    Credits: 10

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    This module in Food Regulations aims to provide learners with a fundamental knowledge and understanding of EU food legislations, food codes and regulations relevant to food, nutrition and the food Industry. 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 food and drink. This module will enhance a learners career in regulatory affairs by developing increasing levels of competence and professionalism by obtain a formal qualification in the food and drink industry.


    Title: Regulatory Affairs (Medical Device)

    Credits: 10

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    This module in Regulatory Affairs (Medical Device) aims to provide learners with a fundamental understanding of EU regulatory systems in the medical device field. 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 EU market. This module will enhance a learners career in regulatory affairs by developing increasing levels of competence and professionalism by obtain a formal qualification in the medical device regulation industry.


    Title: Regulatory Affairs (Pharmaceutical)

    Credits: 10

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    This module in Pharmaceutical Regulations aims to provide learners with a fundamental understanding of EU regulatory systems in the Pharmaceutical and BioPharmaceuticals fields. 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 pharmaceutical and biopharmaceutical products in the EU market.This module will enhance a learners career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the pharmaceutical and biopharmaceutical industries.


  • Semester 2

    Title: Advanced Regulatory Affairs (Food & Drink)

    Credits: 10

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    The module in Advanced Food and Drink Regulatory Affairs (Food Processing Regulations) aims to give students knowledge and understanding of EU food legislation related to general food processing stages. This module will enhance a learners career in regulatory affairs in the application of suitable legislation within the food chain for selected food and food products.


    Title: Advanced Regulatory Affairs (Medical Device)

    Credits: 10

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    This module in Advanced Regulatory Affairs (Medical Device) aims to provide learners with a fundamental understanding of  regulatory systems in the medical device field outside of the EU (USA and Other Jurisdictions). The module will cover the role of regulatory affairs, classification, regulatory structure with respect to the US Food and Drug Administration (FDA), regulatory bodies in Canada, Australia, Japan, and other jurisdictions. This module will enhance a learners career in regulatory affairs by developing increasing levels of competence and professionalism by obtain a formal qualification in the medical device regulation industry in jurisdictions pertinent to the medical device field (Key Markets). Further to this, the module will teach learners about appropriate writing styles and technical writing for regulatory affairs.


    Title: Advanced Regulatory Affairs (Pharmaceutical)

    Credits: 10

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    This module in Advanced Pharmaceutical Regulations aims to provide learners with a fundamental understanding of regulatory

    systems outside of the EU. (USA and Other Jurisdictions) in the Pharmaceutical field. The module will cover the role of regulatory affairs, classification, regulatory structure with respect to the US Food and Drug Administration (FDA), regulatory bodies in Canada, Australia, and Japan.This module will enhance a learners career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the Pharmaceutical regulation industry in jurisdictions pertinent to Pharmaceutical product (Key Markets).


    Title: Auditing and Risk Management

    Credits: 10

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    The aim of this module is to provide learners 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 also 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).


    Title: Computer Systems Validation

    Credits: 10

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    The aim of this module is to provide the learner with a broad overview of 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.

    This module will help the student develop a number of Professional Transferable Skills, such as critical thinking, problem solving, and customer focus.


    Title: Dissertation

    Credits: 30

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    This is a capstone module which draws from modules delivered throughout the programme. The aim of the module is to encourage learners to develop integrative learning and critical reflection as they bring together a range of concepts, theories, frameworks and practices within a research setting.

    The module focuses on the preparation of a large-scale research proposal; analysis and synthesis of extant literature at the forefront of the candidates research interest; application of the findings from literature review to the design; testing and execution of an in-depth; primary research study; interpretation and reporting of findings to supervisor, and the application of both secondary and primary findings to the preparation of clear, well justified conclusions which address the original aims and objectives of the research.

    The learner can opt to take a tradition dissertation or an alternative consultancy dissertation allowing them to work directly with a company on real -word problems applying knowledge from associated modules thus directing their learning to suit their future career objectives.


Are there opportunities for further study?

Students can progress to an appropriate Masters or PHD

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 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 offered by Master of Science in Process Validation & Regulatory Affairs:

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.