Courses in

Analytical, Biopharmaceutical and Medical Science

Certificate in Quality & Regulatory Affairs (Part Time)

Applications for September 2021 are no longer being accepted.

Discipline: Analytical, Biopharmaceutical and Medical Science

Location: Galway - Dublin Road

NFQ Level: 7

Programme Duration: One year

Mode of Study: Part time

Application Route: Apply direct to GMIT

Entry Requirements: Applicants must hold a major award at Level 6 (Higher Certificate) or higher to be eligible to apply.

Places: 30


€800 for Regulatory Affairs & Compliance Auditing
€400 for Cleanroom Management
€400 for Validation

Why Study?

Programme Modules

Follow-on Studies: 

Essential Information: 


• The Certificate commences in September 2021.
• Regulatory Affairs & Compliance Auditing  -  Monday evenings, from 6.30pm-9.30pm, from September 2021 to May 2022.
• Cleanroom Management -  Wednesday evenings, from 7pm to 10pm, from January 2022 to May 2022.
• Validation -  Wednesday evenings, from 6.00pm-9.00pm, from September 2021 to December 2021.

For an overview of the Special Purpose Awards in Quality please see here

Eligibility for the full Level 7 degree:

To do the full Level 7 degree in Quality for Industry, you need to hold a Level 6 award in Science, Business or Engineering.  If you have foreign qualifications, please send an official transcript (with English translation if necessary) to so that we can map your award to the Irish system.

Recognition of your experience in industry (also known as recognition of prior learning (RPL):

If you don’t hold a Level 6 award, but you have significant experience in industry (medical device, or pharmaceutical industry), then you can apply to GMIT to review your work experience to determine if your work experience can be accredited as equivalent to a Level 6 award. To apply for a review or for more information go to


Application Process
***Applications for September 2021 are no longer being accepted.***  


Please refer to this FAQ which may address any specific questions relating to the Quality Special Purpose Awards.


Recognition of Prior Learning may be used to gain access to this programme in accordance with GMIT’s Recognition of Prior Learning policy. For more information on the RPL policy, please visit 


Student Cards

Students who enrol for this Certificate will qualify for issuing of a GMIT Student ID Card. 

Download Document(s): 

Contact Us

Course details

Michelle Healy
Department of Graduate Studies and Professional Development
Dublin Road, Galway

Tel: 091 742452