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

Program Overview

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

Course Overview

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.

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 TUS Recognition of Prior Learning procedures.
• Recognised Prior Learning (RPL) – Assessment: Please review the academic entry requirements for this programme. If you do not hold these qualifications but would like your application to be assessed under RPL please select YES on the online application form.
• 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.

Course Content

Semester 1

• 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.
  • Semester 1: 7.30pm-9.00pm
• 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

• 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 2: 7.00pm-10.00pm

More Information

Delivery

• Student Induction will take place on the evening of Wednesday 3rd September 2025.
• Classes will commence on week commencing 8th September 2025.
• Online
• 2 Semester
• Monday; Wednesday;
• Semester 1: 7.30pm-9.00pm
• Semester 2: 7.00pm-10.00pm
• Live online classes will be recorded and available to watch back
• Proposed Delivery Schedule is Subject to Change.

Time Commitment

• 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.

Assessment

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

Qualification

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

Fees

• This programme is Springboard+ funded in 2025. 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.

Application Deadline

• Limited Places
• Places are allocated on a first come first served basis, prioritizing unemployed and returning applicants.
• The programme will be closed once the maximum number of applicants is reached.
• Final cut off for applications, if spaces are still available, will be Friday 18th July 2025.
• Programmes run subject to viable numbers.

Program Outline

Degree Overview:

The Certificate in Regulatory Affairs and Quality aims to equip students with the fundamental skills required for working in Quality Assurance, particularly in Regulatory Affairs within the (Bio) Pharmaceutical/Medical devices and related industries. It serves as an upskilling opportunity for quality personnel and enables cross-skilling for production personnel seeking a career in Quality Assurance. This certificate is delivered online.

Outline:

• Semester 1:
• Quality Assurance and Validation:
This module delves into the core principles of a quality assurance system within a cGMP environment. It explores the significance and relevance of validation, along with key tools and techniques.
• Cleanroom Management: This module examines the key principles of cleanroom management, including contamination sources, methods for minimizing contamination, cleanroom operation, and differentiation between cleanroom classes (based on FDA, EU, and ISO cGMP standards).
It also explores the principles of cleaning validation.
• Semester 2:
It also discusses ethical issues and vigilance. Students will independently plan, conduct, analyze, and report an audit in accordance with ISO standards.
• Delivery Schedule:
• Semester 1:
Tuesdays and Thursdays, 7:30 PM to 9:00 PM.
• Semester 2: Mondays, 7:00 PM to 9:00 PM.
• Time Commitment:
• Each 5 credit module typically equates to approximately 100 Total Learning Hours.
This includes time spent in class (lectures, tutorials, practical elements) and time spent completing work outside of college. The balance between these varies by discipline and level of study. Students should be aware that the workload will increase at certain times, such as when assignments are due.

Assessment:

• Modules in both semesters are assessed through a combination of Continuous Assessment and Final Examination papers, delivered online.