Courses
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Regulatory Affairs & Quality (Certificate, L7, 20 ECTS)
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Status: Apply Now
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Campus: Online
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years: 1
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Fees: Springboard Funded for 2024. See Fees Section below.
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.
Contact Details
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 TUS Recognition of Prior Learning procedures.
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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.
Once you have submitted your online application you will then receive an email acknowledgement with further instructions on 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.
Course Content
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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.
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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.
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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.
More Information
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The proposed delivery schedule is subject to change.
Semester 1: Tuesday & Thursday – 7.30pm to 9pm.
Semester 2: Monday – 7pm to 9pm
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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.
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The modules in semester 1 and semester 2 will be assessed by a combination of Continuous Assessment and Final Examination papers Online.
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Certificate in Regulatory Affairs & Quality (Special Purpose Award, Level 7, 20 Credits)
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This programme is Springboard+ funded for 2024. Successful applicants in employment will qualify for 90% Springboard+ funding & will be liable for the balance of the 10% fee of €190. Successful applicants on a qualifying DSP payment will qualify for 100% funding.
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11 August 2024. Places are allocated on a first come first served basis, prioritizing unemployed and returning applicants. Course will be closed once the maximum number of applicants is reached. Courses run subject to viable numbers.