Certificate in Quality & Regulatory Affairs (Part Time)Opening for Applications in January 2018
Discipline: 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: None
See Other Essential Information
CAO Round 1 Points: Not Applicable
The purpose of the Certificate in Science in Quality & Regulatory Affairs is to provide students with the basic skills necessary to work in the area of Quality within the pharmaceutical / medical device industries, specifically the Regulatory Affairs aspects of those industries.
This Certificate, along with the Certificate in Science in Quality for Industry - Statistics & Management and the Certificate in Science in Quality, make up the add-on Bachelor of Science (Ordinary) Degree in Quality for Industry.
It is possible to complete this Certificate in Quality & Regulatory Affairs and the Certificate in Quality within two academic years.
Students who pass the assessments for the three modules, or who gain exemption from a module(s) with this Certificate (under GMIT's Recognised Prior Learning process) will obtain the Certificate. The add-on Bachelor of Science (Ordinary) Degree in Quality for Industry is an add-on degree.
You can undertake any/all individual module(s) and you can obtain any/all three Certificates. But to obtain the Bachelor of Science (Ordinary) Degree in Quality you must already hold a Higher Certificate (Level 6, 120 credits) in Business, Engineering or Science.
The makeup of the Certificate in Science in Quality & Regulatory Affairs is:
- Regulatory Affairs & Compliance Auditing (10 Credits Level 7)
- Cleanroom Management (5 Credits Level 7)
- Validation (5 Credits Level 7)
Regulatory Affairs & Compliance Auditing
- Interpret the EU and FDA GMP guidelines and relevant ISO standards.
- Explain the legislative requirements during the various drug development and medical device development phases.
- Explain how a marketing authorization for pharmaceuticals and medical devices is obtained in the EU and the US.
- Detail the various approaches taken to compliance auditing.
- Detail a system for investigation of non-conformances, identification of root cause and corrective / preventive actions.
- Participate in an audit by interpreting relevant legislation and guidelines, identifying any non-conformances and recommend relevant corrective / preventive actions.
- Identify the common sources of contaminants.
- Apply the fundamental steps of aseptic practice.
- Use a wide range of cleaning agents and know when to apply them.
- Define and apply the basis of cleaning validation.
- Work in a clean-room environment.
- Describe the basis of clean-room operation.
- Monitor the clean-room environment.
- Decontaminate the clean-room.
- Explain the role of validation within Good Manufacturing Practice.
- Identify and apply the various validation guidelines and standards in use.
- Apply risk management tools as part of a validation exercise.
- Prepare a validation document in accordance with regulatory guidelines.
- Describe the major steps involved in the validation of critical pharmaceutical and medical device manufacturing operations.
- Describe the approach taken to analytical method validation.
- Complete various validation exercises.
Regulatory Affairs & Compliance Auditing
- Pharmaceutical and Medical Device regulatory affairs - legislation and guidelines.
- Quality Management systems that ensure compliance with relevant legislation and guidelines.
- Marketing authorization processes for medical devices and pharmaceuticals.
- Audit methodologies and tools.
- Interpretation of GMP and ISO guidelines.
- Case studies - performance of audits, audit reporting.
- Actions to rectify non-conformances - identification of root cause, corrective actions, preventive actions.
- Clean-room classifications and standards. Types of clean-rooms, their location within buildings and their various applications in the pharmaceutical industry. Analysis of the fundamentals of air filtration: principles of HEPA filtration and design of HEPA systems and ventilators. Systems of air classification: Federal Standard 209. B.S. 5295. ISO standards etc.
- Selection of walls, ceilings, floor material and equipment. Barrier/Isolator technology. Air showers, weighing cabinets and material pass-through corridors.
- Clothing and housekeeping practices for the clean room staff and maintenance contractors. Critical control of clean-room entrance practices. Standard Operating Procedures for clean-room work.
- Monitoring the quality of materials entering the clean-room. Monitoring air and surface quality in clean-rooms. Monitoring decontamination procedures used in clean-rooms. Clean-room standards for designating normal, alert and alarm levels.
- Introduction to specialized methods of cleaning and decontaminating clean-rooms. Introduction to positive air pressure environments and their use in segregating working areas within clean-rooms. Review of personal behaviour in clean rooms and how this influences clean-room contamination.
- The nature of contamination; physical, chemical and biological residues. Examination of sources of residues and how residues are transported within the work environment. Problems caused by the presences of contaminating residues in pharmaceutical processes. Materials/equipment compatibility and contamination of pharmaceuticals.
- Selection of cleaning agents and items of equipment in use in the pharmaceutical manufacturing sector. Criteria used in the selection of appropriate cleaning agents and equipment.
- Principles of effective cleaning. Understanding the chemistry of cleaning. Writing standard operating procedures describing controlled cleaning practices. Disinfectant effectiveness testing, testing the effectiveness of cleaning agents. Practical monitoring the effectiveness of cleaning regimes. And disinfectants. Cleaning validation made simple.
- Review of good housekeeping practices, procedures and barrier technology used in the control of contamination in pharmaceutical manufacturing facilities. Analysis of facility design and its influence on the spread of contaminants.
- Regulatory basis for validation
- Risk management and its role in validation including review of ISO 1497
- Equipment validation - DQ, IQ, OQ, PQ.
- Pharmaceutical process validation
- Analytical method validation and Good Automated Manufacturing Practice
- Validation of medical devices including key processes including sterilisation
- Change Control
Certificate in Quality (20 Credits, Level 7)
Certificate in Quality - Statistics & Management (20 Credits, Level 7)
Bachelor of Science (Ordinary) Degree in Quality
- €800 for Regulatory Affairs & Compliance Auditing (10 Credits Level 7).
- €400 for Cleanroom Management (5 Credits Level 7).
- €400 for Validation (5 Credits Level 7).
Payment process to be advised in January 2018
Students who enrol for this Certificate will qualify for issuing of a GMIT Student ID Card.
- Regulatory Affairs & Compliance Auditing (10 Credits Level 7) - Monday evenings, from 7pm to 10pm, from September 2018 to May 2019.
- Cleanroom Management (5 Credits Level 7) - Wednesday evenings, from 7pm to 10pm, from January 2019 to May 2019.
- Validation (5 Credits Level 7) - Wednesday evenings, from 7pm to 10pm, from September 2018 to December 2018.
The Certificate commences Monday, 17th September, 2018 and Wednesday, 19th September, 2018.
There are no entry requirements to undertake this Certificate. But if having completed this and the other two Certificates in Quality you wish to obtain the add-on award, Bachelor of Science in Quality, you must hold a Higher Certificate in Business, Science or Engineering. Places will be awarded on a first-come first-served basis for fully completed applications.
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 contact QQI / NARIC website (http://qsearch.qqi.ie/WebPart/Search?searchtype=recognitions) which may be able to map your foreign 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, and if you have significant experience in industry (medical device, or pharmaceutical industry), then you could apply to GMIT to review your work experience to see if your work experience can be accredited as being the same as a Level 6 award. This is called the Recognition of Experiential Learning or Recognition of Prior Learning (RPL). If you wish to apply for recognition of experiential learning, please contact the l You can apply before you start your studies or during your studies but only applications received before the end of April 2018 will be processed before the course begins in September 2018
Applying to study individual certificates or individual modules:
Students who do not hold a Level 6 award, and who do not have sufficient experience to get it recognized as equivalent to a Level 6 can still do all the modules in the degree. They will not graduate with a degree, but will graduate with three separate Certificates. Alternatively, you can apply to do a particular Certificate or a particular module(s).
The course is delivered in the GMIT Galway Campus, Dublin Road, Galway. The room will be advised on the Notice Board in Reception on the first night.
Closing Date for Applications
30th August, 2018. If all places are taken on the course the status of the course will change from “Open for Applications” to “Course Full”.
You must download, complete fully and return by email (not by post) the Application Form which is in the form of a MS-Excel file. Incomplete files/ postal applications will be returned.