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Process Validation and Regulatory Affairs (Master of Science, L9, 90 ECTS)

Status: OPEN (Full Programme Only)


Level

09

Duration

2 Years

Department

Mechanical & Automobile Engineering


Start Date

12/09/2022

Course Type

Flexible & Professional, Postgraduate Taught courses

Location

Online

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.

 

When applying, please select your preferred stream - Food & Drink, Medical or Pharmaceutical.

What are the entry requirements?

Students can transfer from the following three programmes:

Level 9 Postgraduate Diploma in Process Validation and Regulatory Affairs (Food & Drink)

Level 9 Postgraduate Diploma in Process Validation and Regulatory Affairs (Medical)

Level 9 Postgraduate Diploma in Process Validation and Regulatory Affairs (Pharmaceuticals)

OR

(a) A minimum honours bachelor degree (Level 8) in any discipline with minimum two years, relevant work 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 a minimum of 3 years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning 

Or

(d) 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

Who can I contact?

What modules will I study?

Semester 1: 

Quality Management - Mondays 6.30pm-9.30pm

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 (Pharmaceutical / Food & Drink / Medical)

Food & Drink: Tuesdays 7pm-10pm

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.

Medical: Wednesdays 7pm-10pm

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.

Semester 2:

Auditing & Risk Management - Mondays 6.30pm – 9.30pm

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 (Pharmaceutical / Food & Drink / Medical)

Food & Drink: Tuesdays 7pm – 10pm

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 learner’s career in regulatory affairs in the application of suitable legislation within the food chain for selected food and food products.

Medical Devices: Wednesdays 7pm – 10pm

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.

Advanced Pharmaceutical: Wednesdays 7pm - 10pm

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 learner’s 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)

Computer System Validation (Elective) - Thursdays 7pm-10pm

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.

Semester 3:

Dissertation - Wednesday 7:00pm to 8:00 pm

 

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.

Advanced Process Engineering - Tuesdays 7pm - 10pm

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) - Thursdays 7pm - 10pm

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.

Semester 4:

Dissertation - Wednesday 7:00 pm to 8:00 pm

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.

 

More Information

Delivery

100% Online over 2 years. 

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

This Masters 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.

Semester 1: September - December (2 evenings per week)

Number of Days/Evenings per week: 2

Delivery Day/Evening: 

- Monday – Quality Management 

- Tuesday – Product Design control 

Number of Hours per day/evening: 3

Times:

- Monday 6:30pm - 9:30pm Quality Management,

- Tuesday 7:00 pm to 10:00 pm Product Design Control 

Semester 2: January - May (2 evenings per week)

Semester 3: September - December (2 evenings per week)

Semester 4: January - May (1 evening per week)

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.

Assessment 

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.

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. No terminal examinations.

Qualification 

Masters of Science in Process Validation and Regulatory Affairs (Level 9, 90 ECTS)

For queries relating to the course

Contact: Department of Flexible Learning

Email: Flexible@lit.ie

Academic Queries

Email: clodagh.moore@lit.ie

Application Deadline

17th July 2022 (Full programme ONLY)

*There will be a separate application window for Dissertation only students transferring from Postgraduate Diploma in Process Validation & Regulatory Affairs. When registering your interest, ensure to select dissertation only.

Register your interest - Dissertation ONLY

Course Fees

€9,250 Full programme*

€2,500 Dissertation Fee* For those who have successfully completed the Postgraduate in Process Validation & Regulatory Affairs (L9, 60 ECTS)

Click here for all Flexible Learning Policies & Procedures