Course Summary
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.
College Link
Career Sectors
This course prepares you for working in the Career Sectors below. Follow the links to get a fuller understanding of the sectors you are preparing for.
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.
Application Details
Application Deadline: TBC
Register Your Interest: https://lit.ie/Interest-Registration-Dual-Options?coursecode=LC_EPVRT_MOL
When applying, please select your preferred stream - Food & Drink, Medical or Pharmaceutical.
Start date: 01/09/2023
Location: Online
Fees
Register Your Interest: https://lit.ie/Interest-Registration-Dual-Options?coursecode=LC_EPVRT_MOL
When applying, please select your preferred stream - Food & Drink, Medical or Pharmaceutical.
The Student
Career Interests
This course is typically suited for people with the following Career Interests. If these interests do not describe you, this course may prepare you for work you may not find satisfying.
Administrative
Administrative people are interested in work that offers security and a sense of being part of a larger process. They may be at their most productive under supervisors who give clear guidelines and while performing routine tasks in a methodical and reliable way.
They tend to enjoy clerical and most forms of office work, where they perform essential administrative duties. They often form the backbone of large and small organisations alike. They may enjoy being in charge of office filing systems, and using computers and other office equipment to keep things running smoothly. They usually like routine work hours and prefer comfortable indoor workplaces.
Investigative
The Investigative person will usually find a particular area of science to be of interest. They are inclined toward intellectual and analytical activities and enjoy observation and theory. They may prefer thought to action, and enjoy the challenge of solving problems with sophiscticated technology. These types prefer mentally stimulating environments and often pay close attention to developments in their chosen field.
Career Progression
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.
Duration
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)