Admissions & Support
Admissions & Support
Status: Register Your Interest
Fees: €1,900* See FEES section below for funding options
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.
Please visit springboardcourses.ie/eligibility for information on eligibility requirements. This programme is Springboard+ funded in 2023. Successful applicants in employment qualify for 90% Springboard+ Funding and will be liable for the balance of 10% fee of €190. Successful applicants on a qualifying DSP payment qualify for 100% funding. 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. It is also supported by the European Year of Skills 2023.
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.
Recognised Prior Learning (RPL): Prospective applicants who do not meet the academic entry requirements should submit their application online and then email email@example.com to request assessment via RPL.
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.
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.
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
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.
Semester 1: Tuesday & Thursday – 7.30pm to 9pm.
Semester 2: Monday – 7pm to 9pm
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)
This programme was Springboard+ funded in 2023. Successful applicants in employment qualified for 90% Springboard+ funding & were liable for the balance of the 10% fee of €190. Successful applicants on a qualifying DSP payment qualified for 100% funding.
TBC for 2024-2025 Academic Year