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Quality Documentation, GMP & Data Integrity (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
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
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.
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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 Documentation
Good Documentation Practice (GDP), document control and Electronic Document Management Systems
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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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The proposed delivery schedule is subject to change.
Semester One
15 weeks
Sept ’24 – Dec ’24
Mondays 7.30pm -9:00pm
Wednesdays 7.30pm-9:00pmSemester Two
15 weeks
Jan ’25 – Apr ’25
Mondays 7:00pm -10:00pmThis 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.
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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 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.