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Quality Documentation, GMP and Data Integrity (Certificate, L7, 20 ECTS)

  • Location: Online

  • years: 1

  • Level 7

  • Course Type Flexible and Professional Learning

  • Study Mode Part Time

  • Department Applied Science

  • Start Date 02/09/2026

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.







More Information

  • 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

  • (a) QQI Level 6 award, or equivalent qualification in business/engineering or science, and/or relevant life and work experience.

    Or

    Recognition of Prior Learning (RPL) 
    If you do not meet the academic entry requirements listed above but would like your application assessed under RPL please select YES on the online application. Please include details of any relevant work experience/further information relevant to your application.

    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. Please note that we do not request proof of English language qualification or proficiency.

  • Student Induction will take place online on the evening of Wednesday 2nd September 2026.

    Programme delivery will commence the following week.

    Modules are to be delivered over one year in an online learning format.

    Mondays & Wednesdays

    Semester 1: 7.30pm-9pm

    Semester 2: 7.00pm-10 pm

    Proposed delivery schedule is subject to change.

  • 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.

  • Assessments are online via continuous assessments (MCQ, reports, presentations) and/or final online exam.

  • Certificate in Quality Documentation, GMP and Data Integrity (L7, 20 ECTS)

  • €2,000* Springboard funded.

    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.

  • *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.

    Programmes run subject to viable numbers.