Regulatory Affairs and Quality (Certificate, L7, 20 ECTS)

Quality Assurance and Validation (5 ECTS)

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 (5 ECTS)

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.

Regulatory Affairs and Compliance Auditing (10 ECTS)

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.

(a) 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 TUS Recognition of Prior Learning procedures.

Or

Recognition of Prior Learning (RPL) 
If you do not meet the academic entry requirements listed above but would like your application assessed under RPL please select YES on the online application. Please include details of any relevant work experience/further information relevant to your application.

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 score of 5.5 in an IELTS or equivalent exam is required. For postgraduate courses, a score of 6.0 in an IELTS or equivalent exam is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements. Please note that we do not request proof of English language qualification or proficiency.

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 (Level 7, 20 Credits)

€2,000* Springboard funded.

Successful applicants in employment will qualify for 90% Springboard+ funding & will be liable for the balance of the 10% fee of €200.

Successful applicants on a qualifying DSP payment will qualify for 100% funding.

*Limited Places*

Places are allocated on a first come first served basis, prioritizing unemployed and returning applicants.

The programme will close once the maximum number of applicants is reached.

Final closing date for any unfilled places will be the 19th July 2026.

Programmes run subject to viable numbers.