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Quality Systems Validation with Data Analytics

Introduction

The Higher Diploma in Quality Systems Validation with Data Analytics is a 60 credit, 12-month full-time programme. The course is industry focussed to address scientific skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & Healthcare sectors. The HDip is designed with Industry to upskill graduates to become specialised in the area of Validation, Quality Systems. Validation, Statistical Quality Control and Data Analytics are areas that have been identified where skilled graduates are needed.

This programme is aimed at those wishing to transition in the latest developments in data analytics and validation, providing a strong talent pipeline for industry, combining knowledge, skills and expertise. There will be a strong data integrity focus. Upon successful completion of the HDip graduates will have an expert knowledge on the methodologies to ensure quality validation and associated data analytics. The regulatory and validation sections of the course provide an overview of the ISO, INAB, FDA and European regulatory requirements for industry. This includes the requirements of regulatory bodies on validation of software systems used in industry and regulatory requirements on electronic records and signatures, Data Integrity and Quality Risk Management as applied to Computer Systems Validation. The programme places great emphasis on professional development, communication, management and leadership skills, all of which will allow students to develop their career aspirations.

Programme Structure

The programme places significant emphasis on student learning. It adopts a practical, hands-on, approach to learning, where all modules are fully assessed using continuous assessment methods. There are no formal end of semester written examinations and this ensures students will learn by doing from the first module to the last. This 60-credit programme is delivered over two 30 credit semesters. Each taught semester has a number of modules as outlined below. The Experimental Industrial Project and Regulatory Industrial Placement takes place in Semester 2 of the programme where students can be placed in industry to complete an industry related project.

Modules:

Quality Systems, LIMS and SQC (5 credits)
Validation of Quality Systems (5 credits)
Regulatory Affairs & Auditing (5 credits)
Data Analytics & Chemometrics (5 credits)
Professional Development & Communications (5 credits)
Management and Leadership (5 credits)
Regulatory Industrial Placement (10 credits)
Experimental Industrial Project (20 credits)

Department of Physical Sciences

The Department of Physical Sciences at MTU is an amalgamation of the Department of Chemistry and the Department of Physics within the Faculty of Engineering and Science. The department has been delivering major award programmes for over 20 years in the area of Quality and Analytical science. Over 60% of the department’s graduates work in the regional BioPharmaChem & MedTech sector and as a result, the department has very strong linkage within the regional industries where there are ongoing skills gaps for analytical science and quality validation roles. The Department works closely with the University’s Careers Services in development of professional CVs for students, providing both on-line and one-to-one CV preparation techniques and workshops. Interview preparation and mock interviews are also part of workshops delivered in conjunction with the Careers Services.

Delivery:

Blended. Online lectures are streamed live over the Internet and recorded to facilitate easy playback for learners. Delivery generally takes place over 2-3 afternoons/evenings per week. Students maybe required to come on campus for one afternoon per week subject to access restrictions. 

Entry Requirements:

Open to graduates and experienced personnel with a Level 8 qualification in science, life science, business, engineering or related disciplines. Applicants with a level 7 in a Science/Engineering discipline AND extensive relevant industrial experience or training may be considered via the University’s recognition of prior learning (RPL) policy and process. For further details regarding MTU's RPL process, please contact phil.oleary@mtu.ie and see further details: https://www.cit.ie/rpl

Duration:

This programme will be delivered in a blended (online & on-campus) format over two semesters starting from September 2022. Taught modules take place in semester 1 (September - December 2022) and the placement/project modules take place from January to May 2023. 

Cost:

Free or 90% Funded. Fees do not apply to applicants who meet the criteria under the Springboard+ initiative. Visit https://springboardcourses.ie/faq for eligibility criteria.

Apply:

Visit springboardcourses.ie to apply or email your query to Dr Grainne Conneely (grainne.conneely@mtu.ie) or Dr Donagh O’Mahony (donagh.omahony@mtu.ie) for further details

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