Postgraduate Diploma in Science in Process Validation and Regulatory Affairs (Medical) (Limerick) (Limerick - September 22)

Technological University of the Shannon: Midlands Midwest (Limerick-PVRAMED-L9-60)
Key Programme Details
Award

Postgraduate Diploma in Science in Process Validation and Regulatory Affairs (Medical)

NFQ Level

Level 9 About NFQ

Delivery Method

Online

Mode

Full Time

ECTS Credits

60

Department

Department of Mechanical & Automobile Engineering

General Information
Contact

Nicola Kelly

Email

Springboard@lit.ie

Phone

061-293094

Address

*** The Department of Flexible Learning & Springboard+ Team in TUS Midwest request that all supporting documents be uploaded to your online application. Thank you.***

Important Dates
Application Deadline

14/08/2022

Start Date

12/09/2022

End Date

18/12/2023

About this Course

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.

Entry Requirements

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
Or
(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
Or
(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

AND

1. Current CV *must be up to date
2. Proof of existing level 8 educational qualification or equivalent

Please note that successful applicants may be required to provide below supporting documents closer to programme start date. TBC by Springboard HEA.

3. Proof of nationality ie. passport
4. Proof of PPS/employment/social welfare/returner status dated within the last month
5. Proof of Residency (2019, 2020, 2021)

ASSESSMENT: As assessments will be 100% Continuous Assessment and mainly industry based, learners are required to engage with industry and industry representatives in various cross disciples through continuous assessment and industry-based projects. This will prepare learners to be industry ready and apply the transferable skills gained through module content, industry engagement, and strengthened by industry-based assessments. Students will be assessed on their learning by a variety of strategies including:
The use of continuous assessment through projects, coursework, multiple choice questions, e-tivities, presentations and assignments. 100% Continuous assessment i.e. NO terminal examinations.

ENGLISH LANGUAGE:
Applicants who do not have English as their first language must ensure they satisfy English Language requirements. For entry to undergraduate courses, a minimum score of 5.5 in an IELTS exam is required. For postgraduate courses, a minimum of 6.0 is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements. We do not require proof of IELTS however, each applicant must ensure that their English is to above standard and they will be able to participate without any language barrier.

FEES: The overall fee for this programme is €6,750. Applicants in employment/recent graduates will qualify for 90% Springboard+ funding and the 10% fee to be paid will be €675. Please note that this 10% fee is non-refundable and must be paid in full before you commence your programme of study. Applicants on a qualifying DEASP payment for 9 of the previous 12 months / returners will qualify for 100% funding.

This course will be Springboard funded for 22-23 academic year only. Applicants must complete this programme within this academic year. It is not possible to defer your place to the following academic year as we cannot guarantee that this course will run or be funded again. We would also advise you to review Former Springboard+ Participant guidelines, please copy & paste into your browser: https://springboardcourses.ie/pdfs/Guidelines%20on%20applications%20from%20previous%20Springboard%20participants%202019.pdf

TUS Flexible Learning Policies & Procedures are available through below link. Please copy & Paste into your browser:
https://lit.ie/en-ie/study-at-lit/course-information/flexible-learning-professional-courses/policies-and-procedures

Successful Springboard applicants will be required to complete registration via the Springboard portal throughout the academic year to secure funding for their place.***IMPORTANT NOTE: If your employment status changes during the application process this may affect your fees and Springboard funding. It is your responsibility to inform us by email to Springboard@lit.ie and to provide proof of new status***

Long Description

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.

Semester 1: September 2022 - December 2023

Quality Management - Mondays 6.30pm-9.30pm

The aim of this module is to facilitate an in-depth understanding of quality and quality management, from the various definitions of quality, through to the practical application of systems and processes to manage quality. Learners will be equipped with the knowledge and skills to be able audit all, or part of, organisation's formal Quality Management systems against defined criteria such as ISO 13485, ISO 9001 or 21 CFR Part 820. Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

Regulatory Affairs (Medical) - Wednesdays 7pm-10pm

Provide learners with an understanding of EU regulatory systems in the medical device field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the EU market. This module 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. This module will enhance a learner's career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the medical device regulation industry.

Semester 2: January 2023 - May 2023

Auditing and Risk Management - Mondays 6.30pm - 9.30pm

Learners will gain an in-depth understanding of the application of Risk Management within organisational Quality Management Systems. Learners will 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. There will also be a focus on managing external audits by second and third parties (customers and regulators/notified bodies). Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

Advanced Regulatory Affairs (Medical) - Wednesdays 7pm - 10pm

Understanding of the utilisation of standards, FDA and other jurisdictions' guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the world market.

Computer Systems Validation (Elective) - Thursdays 7pm-10pm

An overview of software validation in a manufacturing or software environment. The focus will be on software validation in a manufacturing or software environment. To evaluate software validation approaches, models, development, implementation, testing and maintenance of validated software. The importance and application of validation management, reporting and risk management in a manufacturing/software environment will be defined and evaluated.

Semester 3: September 2023 - December 2023

Advances Process Engineering - Tuesdays 7.00pm - 10.00pm

The aim of this modules is to provide the learner with a knowledge of process engineering management in a manufacturing environment. A learner will be able to evaluate process types, designs, layouts, process analysis, forecasting of product, capacity planning while ascertaining a knowledge of current technologies and automation used in the manufacturing.

Process Validation (Elective) - Thursdays 7pm - 10pm

Provide the learner with an overview of process and product validation in manufacturing environments. The focus will be on Process validation with emphases on the tools and techniques that are used in the operations and manufacturing environment; to ensuring that operations are efficient in terms of using as few resources as needed, compliance with regulatory requirements and be effective in terms of meeting customer requirements.

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.

Career Opportunities

There are multiple roles a graduate from the programme can seek in disciplines such as Quality Engineering, Management, Auditing, Compliance, Legal and Regulatory Affairs.

Furthermore, there are multiple roles a graduate from the programme can seek in areas such as Regulatory Engineer, Process Engineer, Validation Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Validation Management, Quality Management, Quality Management Systems, Quality Assurance, Compliance and Auditing Management, Risk Management.

International Opportunities:

The content of the modules will be seen to reflect a globalised environment .This is demonstrated by the regulatory affairs module stream which focuses on EU, US and worldwide regulatory affair bodies.

This is further demonstrated through the quality management module stream as learners will receive internationally recognised award in ISO9001:2015 Lead Auditor, which equips learner to be lead auditors world-wide. Thus will be equipped with the knowledge and skills to be able audit all, or part of, organisation's formal Quality Management systems against defined criteria such as international standards ISO 13485, ISO 9001 or 21 CFR Part 820.

Students can transfer on to the Masters of Science in Process Validation and Regulatory Affairs. Holders of this Level 9 Graduate diploma will be required to complete one 30 credit Dissertation Module to obtain the L9 Masters >>> https://lit.ie/en-ie/courses/masters-of-science-in-process-validation-and-regul

Timetable Info

This programme will run online from September 2022 to December 2023
8 hours per week. Exact timetable TBC.

Semester 1: September - December

Semester 2: January - May

Semester 3: September - December

Number of Weeks: 12 per semester
Number of Days/Evenings per week: 2 evenings per week
Delivery Day/Evening: Monday and Wednesday* (*TBC Semester 1)
Number of Hours per day/evening: 3 hours
Times:6:30 pm to 9:30 pm (Mon) 7:00 pm to 10:00pm (Wed)

Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.

Delivery Location

100% Online.

Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.

Delivery Notes

This programme will run online from September 2022 to December 2023
8 hours per week. Exact timetable TBC.

Semester 1: September - December

Semester 2: January - May

Semester 3: September - December

Number of Weeks: 12 per semester
Number of Days/Evenings per week: 2 evenings per week
Delivery Day/Evening: Monday and Wednesday* (*TBC Semester 1)
Number of Hours per day/evening: 3 hours
Times:6:30 pm to 9:30 pm (Mon) 7:00 pm to 10:00pm (Wed)

Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.

Admissions Contact Details
Contact Person

Nicola Kelly

Address

*** The Department of Flexible Learning & Springboard+ Team in TUS Midwest request that all supporting documents be uploaded to your online application. Thank you.***

Phone

061-239055

Email

Springboard@lit.ie

RPL Information

Recognition of Prior Learning (RPL) may be granted based on relevant experience and training in accordance with TUS's RPL Policy.

Application Procedures

Apply online at www.springboardcourses.ie. Once you submit your application you will receive an automated acknowledgement email with a unique reference application number. Please quote this reference number when contacting Springboard TUS.

To complete your application you must upload the following Supporting Documents to your online application.

1. Current CV *must be up to date
2. Proof of existing level 7/8 educational qualification or equivalent

Please note that successful applicants may be required to provide below supporting documents closer to programme start date. TBC by Springboard HEA.

3. Proof of nationality ie. passport
4. Proof of PPS/employment/social welfare/returner status dated within the last month
5. Proof of Residency (2019, 2020, 2021)

Please note that places are LIMITED and only COMPLETE applications can be assessed. Please apply online here for your programme and ensure ALL Supporting Documents are uploaded to your application. The onus is on each applicant to ensure ALL documents are uploaded. TUS will not pursue applicants for missing documents.

This programme is 90% funded for those in employment/recent graduates who completed their studies in 2021/2022. Students who fall into this category must pay a 10% fee of €650 to secure their place on the programme. This 10% fee is non-refundable and must be paid prior to course commencement. Applicants on a qualifying DEASP payment/returners will qualify for 100% funding.

RECENT GRADUATES: Recent graduates with at least level 8 qualification in a relevant subject (2021/22) are eligible to apply and will be required to pay 10% of the tuition fee.

UNEMPLOYED: Those in receipt of an eligible payment from the Department of Employment Affairs and Social Protection (DEASP) must be in receipt of this payment for 9 of the previous 12 months. Applicants must inform their local DEASP Office that they are undertaking an HCI Pillar 1 graduate conversion course.

RETURNERS: If you are a returner who has been on home or other caring duties for 9 of the last 12 months OR you are economically dependent on a partner or spouse and have been unemployed for 9 of the last 12 months you must supply a notarized affidavit confirming this. Form download located here: https://springboardcourses.ie/pdfs/Declaration%20for%20Returners%20(2022-23).pdf

FEES: The overall fee for this programme is €6750. Applicants in employment/recent graduates will qualify for 90% Springboard+ funding and the 10% fee to be paid will be €675. Please note that this 10% fee is non-refundable and must be paid in full prior to course commencement. Applicants on a qualifying DEASP payment for 9 of the previous 12 months / returners will qualify for 100% funding.

This course will be Springboard funded for 22-23 academic year only. Applicants must complete this programme within this academic year. It is not possible to defer your place to the following academic year as we cannot guarantee that this course will run or be funded again. We would also advise you to review Former Springboard+ Participant guidelines, please copy & paste into your browser: https://springboardcourses.ie/pdfs/Guidelines%20on%20applications%20from%20previous%20Springboard%20participants%202019.pdf

TUS Flexible Learning Policies & Procedures are available through below link. Please copy & Paste into your browser:
https://lit.ie/en-ie/study-at-lit/course-information/flexible-learning-professional-courses/policies-and-procedures

Successful Springboard applicants will be required to complete registration via the Springboard portal throughout the academic year to secure funding for their place.***IMPORTANT NOTE: If your employment status changes during the application process this may affect your fees and Springboard funding. It is your responsibility to inform us by email to Springboard@lit.ie and to provide proof of new status***

Media
Part-Time Flexible Learning

https://lit.ie/flexible-learning