Certificate in Regulatory Affairs and Quality (Limerick) (Limerick - Sept 22)

Technological University of the Shannon: Midlands Midwest (Limerick-RAQ-L7-20)
Key Programme Details
Award

Certificate in Regulatory Affairs & Quality (Special Purpose Award, Level 7, 20 Credits)

NFQ Level

Level 7 About NFQ

Delivery Method

Online

Mode

Part Time

ECTS Credits

20

Department

Applied Science

General Information
Contact

Daragh Sutton

Email

Springboard@lit.ie

Phone

+353 61 293055

Address

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

Role

Programme Administrator

Important Dates
Application Deadline

01/07/2022

Start Date

12/09/2022

End Date

26/05/2023

About this Course

Regulatory Affairs and Quality is a 20 credit, Special Purpose Award at Level 7. The aim of this Certificate in Regulatory Affairs and Quality is to provide skills necessary to work in the area of Quality and Regulatory Affairs within the pharmaceutical /biopharmaceutical /medical device and other related industries. It is aimed at participants who wish to upskill and/or cross skill to gain further skills and knowledge in the areas of quality assurance, validation, auditing, cleanroom management and regulatory affairs.

The Certificate is composed of 3 modules
1.Cleanroom Management
2.Quality Assurance and Validation
3.Regulatory Affairs and Compliance Auditing.

This course is delivered entirely online with a combination of live and pre-recorded lectures all available on our virtual learning platform-Moodle. As part of induction all participants will become familiar with Moodle, MS Teams, Zoom and any other college specific resource. Assessment are online via continuous assessments (MCQ, reports, presentations) and/or final online exam.

Entry Requirements

1. Proof of Level 6 qualification or approved equivalent in Business, Engineering or Science
2. Current CV *must be up to date

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 (see below)
5. Proof of Residency 2019, 2020, 2021 (see below)

Recognised Prior Learning (RPL) / Special Case Registrations: Prospective participants who do not meet the educational qualification 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 here and then email Springboard@lit.ie requesting consideration under TUS’s RPL policy. Please state your unique Springboard reference number, name and chosen course.

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 each 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.

EXAMS: The modules in semester 1 and semester 2 will be assessed by a combination of Continuous Assessment and Final Examination papers Online.

Please note that the exams for this course will take place weekdays, during daytime hours i.e. between the hours of 9am and 6pm. TBC closer to Exam Time.

FEES: The overall fee for this programme is €1,900. Applicants in employment will qualify for 90% Springboard+ funding and the 10% fee to be paid will be €190. 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 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

Click here for all Flexible Learning Policies & Procedures: 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

Regulatory Affairs and Quality is a 20 credit Special Purpose Award at Level 7. The aim of this Certificate in Regulatory Affairs and Quality is to provide skills necessary to work in the area of Quality and Regulatory Affairs within the pharmaceutical /biopharmaceutical /medical device and other related industries. It is aimed at participants who wish to upskill and/or cross skill to gain further skills and knowledge in the areas of quality assurance, validation, auditing, cleanroom management and regulatory affairs.

The Certificate is composed of 3 modules
1.Cleanroom Management
Key principles of a quality assurance system within a cGMP environment will be discussed. The importance and relevance as well as key tools and techniques of validation will be explored.

2.Quality Assurance and Validation
Key principles of cleanroom management will be explored including contamination sources, ways to minimise contamination, cleanroom operation and differentiation between cleanroom classes (FDA, EU and ISO cGMP standards). The principles of cleaning validation will also be explored.

3.Regulatory Affairs and Compliance Auditing.
The regulatory framework at a national, regional and international level relating to the pharmaceutical, medical devices and allied industries will be explored. Ethical issue and vigilance will also be discussed. Finally, you will independently plan and conduct, analyse and report an audit in accordance with ISO standards.

This course is delivered entirely online with a combination of live and pre-recorded lectures all available on our virtual learning platform-Moodle. As part of induction all participants will become familiar with Moodle, MS Teams, Zoom and any other college specific resource.

Assessment
Assessment are online via continuous assessments (MCQ, reports, presentations) and/or final online exam.

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

Gain the skills to work in the area of quality within the pharmaceutical / biopharmaceutical / medical device and other related industries.

Timetable Info

TBC 2022

Online delivery 1 evening per week (TBC), 3 hours per week
6.30pm - 9.30pm
30 weeks

Delivery Location

TBC 2022

Online delivery 1 evening per week (TBC), 3 hours per week
6.30pm - 9.30pm
30 weeks

Delivery Notes

TBC 2022

Online delivery 1 evening per week (TBC), 3 hours per week
6.30pm - 9.30pm
30 weeks

Admissions Contact Details
Contact Person

Daragh Sutton

Address

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

Phone

+353 61 293055

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 here 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 the application process you must upload the following supporting documents via the Springboard portal. Supporting documents will not be accepted via email/post as they must be accessible via the Springboard portal to secure funding for your place:

1. Current CV *must be up to date
2. Proof of existing level 6 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 (see below)
5. Proof of Residency (2019, 2020, 2021)

Please note that places are LIMITED and only COMPLETE applications can be assessed by the Programme Team. 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. Students who fall into this category must pay a 10% fee of €190 to secure their place on the programme. This 10% fee is non-refundable and must be paid before commencement date.

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.
Link to form here: https://springboardcourses.ie/pdfs/Declaration%20for%20Returners%20(2022-23).pdf

EXAMS: The modules in semester 1 and semester 2 will be assessed by a combination of Continuous Assessment and Final Examination papers Online.

Please note that the exams for this course will take place weekdays, during daytime hours i.e. between the hours of 9am and 6pm. TBC closer to Exam Time.

FEES: The overall fee for this programme is €1,900. Applicants in employment will qualify for 90% Springboard+ funding and the 10% fee to be paid will be €190. 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 will qualify for 100% funding.

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

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

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