Courses
Admissions & Support
Quality Documentation, GMP and Data Integrity (Certificate, L7, 20 ECTS)
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Status: Apply Now
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Location: Online
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years: 1
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Fees: €2000. This programme is funded by Springboard + for the 25-26 Academic Year. See Fees section below for further details.
Course Overview
Quality Documentation, GMP & Data Integrity is a 20 credit special purpose award at level 7. The aim of this Certificate is to provide the skills necessary to work in the areas of quality control, quality assurance, manufacturing and auditing within the pharmaceutical /biopharmaceutical /medical device and other related industries. It is aimed at participants who wish to upskill and/or cross skill to gain further skills and knowledge in the areas of GMP, quality documentation and data integrity to maintain a compliant system throughout the product lifecycle.
Contact Details
Academic Queries
Tracey Larkin
Email: tracey.larkin@tus.ie
Siobhan Curtin
Email: siobhan.curtin@tus.ie
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.
or
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
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Semester 1
Quality DocumentationGood Documentation Practice (GDP), document control and Electronic Document Management SystemsGMPThe principles of GMP, cGMP, Regulations for the pharma, biopharma & medical devices sectors.
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Semester 2
Data IntegrityData integrity principles, standards and control for physical and electronic data management systems -
GMP
The principles of GMP, cGMP, Regulations for the pharma, biopharma & medical devices sectors.
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Data Integrity
Data integrity principles, standards and control for physical and electronic data management systems
More Information
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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: 7.30-9.00 pm and Semester 2: 7.00pm-10.00 pm
Semester 1:
Quality Documentation
Good Documentation Practice (GDP), document control and Electronic Document Management Systems
GMP
The principles of GMP, cGMP, Regulations for the pharma, biopharma & medical devices sectors.
Semester 2:
Data Integrity
Data integrity principles, standards and control for physical and electronic data management systems”
Live online classes will be recorded and available to watch back (remove if not)
Proposed Delivery Schedule is Subject to Change.
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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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Assessments are online via continuous assessments (MCQ, reports, presentations) and/or final online exam.
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Certificate in Quality Documentation, GMP and Data Integrity (Special Purpose Award, Level 7, 20 Credits)
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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.
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*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.