Validation Science

Overview

This Special Purpose Award in Validation Science provides an accredited level 7 qualification in validation science over one year for individuals who are seeking to up-skill or cross-skill in order to gain suitable employment in sectors such as biopharmaceutical, pharmaceutical and medical device industries. This course is endorsed by Engineers Ireland as a Continuing Professional Development (CPD) training course.

This programme has been developed in response to the requests from the industrial participants in the South Western Skills Forum.  The programme targets employment roles in production/ manufacturing, quality assurance, regulatory affairs, commissioning, qualification, validation and operation roles within pharmaceutical/biotechnology/medical device manufacturing companies.

An innovative and key feature of this programme is the involvement of industry champions who deliver workshops, webinars and case studies that reinforce the fundamental content delivered by the academic lecture team, shaping the student’s knowledge on validation in the industrial workplace. Industrial collaborators include Janssen, DPS Engineering, PM group, Alcon, Boston Scientific, AbbVie, ThermoFisher, MSD and Astellas.

Course Start Date

25th September 2024

Course Delivery

The programme is delivered over two semesters of 13 weeks by online delivery and an online assessments/submissions.

Semester 1

Industry Workshops 4 times over the semester, 6pm – 9pm on Wednesdays.

You will be given more information on the specific Wednesdays once the programme commences in September. Online presentations and webinars to be taken at your own time throughout the semester.

Semester 2

Industry Workshops 4 times over the semester, 6pm – 9pm on Wednesdays.

You will be given more information on the specific Wednesdays once the programme commences in September. Online presentations and webinars to be taken at your own time throughout the semester.

Award

Special Purposed Award - Certificate in Validation Science (Level 7, 10 ECTs, on the National Framework of Qualifications).

What will I study?

From completing this course, students will gain:

• Valuable knowledge and key skills in subject areas pertinent to working in highly regulated manufacturing environments such as GMP, QA, QC and Validation. 
• Knowledge and understanding of the principles of quality regulation as required by the principles of current Good Manufacturing Practice.
• An understanding of the importance of validation of equipment, plant, utilities, processes and procedures in industry will be shown to be an essential approach to consistently producing products of the intended quality.
• An understanding of the increasing regulatory requirements relevant to the biomedical, pharmaceutical and biopharmaceutical industry.

The proposed modules are focused not only on the biotechnological industries but also find applications into other regulatory compliant environments such as the pharmaceutical and medical technology sectors.

The programme consists of two modules: Introduction to Validation (semester one) and Validation Science (semester two). The programme uses a mixture of online multiple choice question assessments and online submission of assignments.

The first introductory module is a blended module and will consist of a mixture of online teaching, lectures and workshops. Several industry champions will deliver workshops and webinars that will reinforce the fundamental content delivered by the academic lecture team.

The second module gives the student a broad understanding of the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical and medical device industries. The principles of risk assessment techniques in validation are applied.

Industry generated case studies focusing on different aspects linked to different learning outcomes, online lectures/seminars and Industry Guest Lecturers for webinars are vital components of these two modules.

Entry Requirements

All qualified candidates are required to have a minimum of a Level 6 qualification (120 credits), or equivalent, in an engineering or science discipline. Candidates may also be interviewed for positions on the programme.

What is RPL?

Recognition of Prior Learning (RPL) is when formal recognition is given for what you already know prior to starting on a programme or module. With recognition of prior learning the focus is on learning and not on experience as such. You can apply for RPL in any MTU accredited programme or module. Programmes which are accredited by professional bodies or any external awarding bodies may have their own procedures for RPL which you should refer to.

Fees

€1,250

Please note that applicants will be required to pay an acceptance fee of €500 online if a place on a course is offered. This fee is deductible from the overall course fee. 

Note: You will not be charged for applying for the programme by clicking the 'apply now' button; you are only asked to pay an acceptance fee if a place is offered to you, and you wish to accept it.

Career options

Graduate Feedback

Following a survey of MTU graduates from the course, here are some impactful information:

• The skills and knowledge gained from the course has helped me in search of employment: 43% strongly agree; 19% agree and 38% neither agree or disagree
• Contained up-to-date, relevant and useful and knowledge for employment: 77% strongly agree; 23% agree
• Career has developed and grown since completing the course: 46% strongly agree; 15% agree and 39% neither agree or disagree.
• 100% agreed that the course met their needs and lived up to their expectations.

• 96% would recommend the course.

“This course is good to give people a flavour of different areas that need to be validated/qualified in a Biopharma/Medical Device facility to ensure regulatory & legal compliance. I was already employed in the industry while studying, and the course has been asked about at job interviews, even while still studying”.

 “The course helped me to improve my skills at my current position”

“I would strongly recommend this course to those who are considering entering manufacturing to go on this course”

“The coursework was very well structured and informative. The rate of learning and the release dates of new lectures were excellently timed and I found the format exceptional. At no point did I find it to slow or to quick. Just right!

“Online lectures were sharp, effective and efficient. Workshops were very informative with very concise speakers”