Postgraduate Diploma in Science in Process Validation and Regulatory Affairs (Medical)
Status: Opening June 21
Mechanical & Automobile Engineering
Flexible & Professional
*** This programme will open in June 2021 for online applications. Please email Springboard@lit.ie to be added to the Interest List and you will receive an email alert when we open for applications. **
Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing. The aim of the Graduate Diploma in Process Validation and Regulatory Affairs (Medical) is to equip learners with the knowledge, skills and insight required to be effective leaders in manufacturing and regulated industries.
This programme will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. The programme will enable understanding of all current applicable regulations, quality management systems and effective process validation requirements.
Learners will have the knowledge and skills to be able audit all, or part of, organisation's formal Quality Management systems. Acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes; ensuring that learners will develop skills to address and prepare for the ever-changing environment of regulatory affairs.
Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.
What are the entry requirements?
a) A minimum honours bachelor degree (Level 8) in any discipline with minimum two years relevant work based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning
(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three years relevant work based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning
(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International
frameworks will also be considered. International students must evidence a proficiency in English language for
example IELTS 6.0
(d) Recognised Prior Learning (RPL) / Special Case Registrations: Prospective participants who do not meet the entry requirements for the programme detailed above, but who may qualify for admission by meeting certain other equivalent criteria, should notify the Flexible Learning Office and request consideration under RPL. Please submit your application online and then email all your supporting documents to Springboard@lit.ie
What modules will I study?
Quality Management: This module facilitates an in-depth understanding of quality, quality management and systems
Auditing and Risk Management: Knowledge and skills to be able audit organisation's formal Quality Management systems.
Process Engineering Management: Process management together with tools and techniques used in the manufacturing environment.
Process Validation (Elective): Provide the learner with an overview of process and product validation in manufacturing environments
Computer Systems Validation (Elective): An overview of software validation in a manufacturing or software environment.
Regulatory Affairs (Medical): Provide learners with an understanding of EU regulatory systems in the medical device field.
Advanced Regulatory Affairs (Medical): Understanding of the utilisation of standards, FDA and other jurisdictions guidance documents and technical writing.
This programme will run online from September 2021 to December 2022
8 hours per week. Exact timetable TBC.
Lectures will be delivered 100% online via Moodle. Lectures will be recorded and available to watch back.
What will the time commitment be?
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. The balance between these two varies by discipline, and by level of study. You should bear in mind that the workload will increase at particular times e.g. when assignments are due.
This programme will be assessed through 100% continuous assessment.
Postgraduate Diploma in Science in Process Validation and Regulatory Affairs - Medical. (Level 9, 60 ECTS)
For queries relating to the course
Contact: Department of Flexible Learning
LIT Moylish, Tel: 061 293055
€675 is the subsidised fee for employed applicants. This programme is 90% Springboard funded for employed applicants and 100% Springboard funded for unemployed applicants.
Springboard+ is co-funded by the Government of Ireland and the European Social Fund as part of the ESF programme for employability, inclusion and learning 2014-2020.
Human Capital Initiative Pillar 1 is funded by the National Training Fund.