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Regulatory Affairs & Quality (L7, 20 ECTS)

Status: Register Your Interest (Sept-23)




1 Year


Applied Science

Start Date


Course Type

Flexible & Professional



The aim of the Certificate in Regulatory Affairs and Quality is to provide the basic skills necessary to work in the area of Quality especially regulatory affairs within the (bio) pharmaceutical/medical devices and other related industries. It provides an ideal upskilling opportunity for quality personnel and also enables cross-skilling of production personnel planning for a career in quality assurance. This certificate will be delivered online.

What are the entry requirements?

QQI Level 6 award, or equivalent qualification in business/engineering or science, and/or relevant life and work experience. Applicants may also be eligible for entry according to LIT’s Recognition of Prior Learning procedures.

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 minimum score of 5.5 in an IELTS exam is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements.

Who can I contact?

What modules will I study?


The programme comprises of three modules.

Semester 1:  Sept- Dec

Quality Assurance and Validation

Key principles of a quality assurance system within a cGMP environment will be discussed. The importance and relevance as well as key tools and techniques of validation will be explored.

Cleanroom Management

Key principles of cleanroom management will be explored including contamination sources, ways to minimise contamination, cleanroom operation and differentiation between cleanroom classes (FDA, EU and ISO cGMP standards). The principles of cleaning validation will also be explored.

Semester 2:  Jan-May

Regulatory Affairs and Compliance Auditing

The regulatory framework at a national, regional and international level relating to the pharmaceutical, medical devices and allied industries will be explored. Ethical issue and vigilance will also be discussed. Finally, you will independently plan and conduct, analyse and report an audit in accordance with ISO standards.


Are there opportunities for further study?

More Information


Online delivery 1 evening per week (TBC), 3 hours per week
6.30pm - 9.30pm
30 weeks

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.


The modules in semester 1 and semester 2 will be assessed by a combination of Continuous Assessment and Final Examination papers Online.


Certificate in Regulatory Affairs & Quality (Special Purpose Award, Level 7, 20 Credits)

Application Deadline

TBC for Sept.23

For queries relating to the course


For academic queries

Contact: Siobhan Curtin


Course Fees

Full fees: €1,900. TBC for Sept.23

This programme is Springboard funded in 2022.

Please see here for eligibility criteria details.

Please see this link for full course information:

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.

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.