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

  • Status: Register Your Interest

  • Campus: Online

  • years: 1

  • Fees: €1,900* See FEES section below for funding options


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.







Please visit springboardcourses.ie/eligibility for information on eligibility requirements.  This programme is Springboard+ funded in 2023. Successful applicants in employment qualify for 90% Springboard+ Funding and will be liable for the balance of 10% fee of €190. Successful applicants on a qualifying DSP payment qualify for 100% funding. 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. It is also supported by the European Year of Skills 2023. 

Contact Details

General Queries

Flexible Learning Office

Email: springboard.midwest@tus.ie

Telephone: (061) 293802

Academic Queries

Dr. Tracey Larkin

Email: Tracey.Larkin@tus.ie

Academic Queries

Siobhan Curtin

Email: siobhan.curtin@tus.ie

What are the entry requirements?

Applicants should have a Higher Certificate in Business, Engineering or Science at level 6. Applicants may also apply for Recognition of Prior Learning.

or

Recognised Prior Learning (RPL): Prospective applicants who do not meet the academic entry requirements should submit their application online and then email springboard.midwest@tus.ie to request assessment via 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

  • 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.

  • Data Integrity

    Data integrity principles, standards and control for physical and electronic data management systems

More Information

  • This course is delivered entirely online with a combination of live and pre-recorded lectures all available on our virtual learning platform-Moodle. As part of induction all participants will become familiar with Moodle, MS Teams, Zoom and any other college specific resources.

     

  • 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 (Special Purpose Award, Level 7, 20 Credits)

  • This programme was Springboard+ funded in 2023. Successful applicants in employment qualified for 90% Springboard+ funding & were liable for the balance of the 10% fee of €190. Successful applicants on a qualifying DSP payment qualified for 100% funding.

  • TBC for 2024-2025 Academic Year