Regulatory Affairs & Quality (L7, 20 ECTS)
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.
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.
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?
This Certificate, along with Certificate in Quality Management & Statistics and Certificate in Quality Documentation, GMP and Data Integrity can be combined to make up the add on Bachelor of Science in Quality (Level 7).
Online delivery 1 evening per week (TBC), 3 hours per week
6.30pm - 9.30pm
30 weeks (September 2021 to May 2022)
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)
22nd July 2021
For queries relating to the course
For academic queries
Contact: Siobhan Curtin
Full fees: €1,800
This programme is Springboard funded in 2021 and the fee for employed applicants is €180.
Please see here for eligibility criteria details.
Please see this link for full course information: https://springboardcourses.ie/details/9113
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.