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

Status: CLOSED




2 Years


Mechanical & Automobile Engineering

Start Date


Course Type

Flexible & Professional



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)


(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 


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 


(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

Regulatory Affairs (Pharmaceutical / Food & Drink / Medical)

Semester 2:

Auditing & Risk Management 

Advanced Regulatory Affairs (Pharmaceutical / Food & Drink / Medical)

Computer System Validation (E)

Semester 3:


Advanced Process Engineering

Process Validation (E)

Semester 4:


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


100% Online over 2 years

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


- 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.


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.


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

For queries relating to the course

Contact: Department of Flexible Learning


Academic Queries


Application Deadline

29th August 2021

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



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