Quality Documentation, GMP and Data Integrity

Program Overview

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.

Course Details

Level

• Level 7

Course Type

• Flexible and Professional Learning

Study Mode

• Part Time

Department

• Applied Science

Start Date

• 03/09/2025

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.

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.

Course Content

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
• GMP
  • The principles of GMP, cGMP, Regulations for the pharma, biopharma & medical devices sectors.

Delivery

• 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

Time Commitment

• 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.

Assessment

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

Qualification

• Certificate in Quality Documentation, GMP and Data Integrity (Special Purpose Award, Level 7, 20 Credits)

Fees

• 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.

Application Deadline

• 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.

Program Outline

It aims to equip participants with the skills necessary to work in quality control, quality assurance, manufacturing, and auditing within the pharmaceutical, biopharmaceutical, medical device, and related industries. The program targets individuals seeking to upskill or cross-skill in GMP, quality documentation, and data integrity to maintain a compliant system throughout the product lifecycle.

Outline:

Semester 1:

• Quality Documentation: Covers Good Documentation Practice (GDP), document control, and Electronic Document Management Systems.
• GMP: Explores the principles of GMP, cGMP, and regulations for the pharmaceutical, biopharmaceutical, and medical devices sectors.

Course Schedule:

• Semester One: 15 weeks, September 2024 – December 2024, Mondays 7:30pm - 9:00pm and Wednesdays 7:30pm - 9:00pm.
• Semester Two: 15 weeks, January 2025 – April 2025, Mondays 7:00pm - 10:00pm.

Delivery:

The program is delivered entirely online with a combination of live and pre-recorded lectures available on the virtual learning platform Moodle. Participants will be introduced to Moodle, MS Teams, Zoom, and other college-specific resources during induction.

Time Commitment:

Each 5 credits typically equates to approximately 100 Total Learning Hours, including class time and independent work. The workload may increase at specific times, such as when assignments are due.

Assessment:

Assessments are conducted online through continuous assessments (MCQ, reports, presentations) and/or a final online exam.