Certificate in Quality Documentation, GMP and Data Integrity (September 2021)

Limerick Institute of Technology (SB21-QDGMPDI-L7-20)
Key Programme Details
Award

Certificate in Quality Documentation, GMP and Data Integrity (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

Sinéad Liston

Email

springboard@lit.ie

Phone

+353 061 293026

Address

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

Important Dates
Application Deadline

23/07/2021

Start Date

13/09/2021

End Date

26/05/2022

About this Course

Quality Documentation, GMP & Data Integrity is a 20 credit, Special Purpose Award at level 7. The aim of this Certificate is to provide the skills necessary to work in the areas of quality control, quality assurance, manufacturing and auditing 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 GMP, quality documentation and data integrity to maintain a compliant system throughout the product lifecycle.

The Certificate is composed of 3 modules
1.Good Manufacturing Practice (GMP)
2.Quality Documentation
3.Data Integrity

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

Entry Requirements

1. Applicants must have proof a Higher Certificate in Business, Engineering or Science at level 6. Applicants may also apply for Recognition of Prior Learning
Current CV *must be up to date
Proof of nationality ie. passport
Proof of employment/social welfare/returner status dated within the last month (see below)

2. 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 LIT’s RPL policy. Please state your unique Springboard reference number, name and chosen course.

3. 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.

4. EXAMS: Continuous assessment assignment and projects will be set during the programme.

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.

5. FEES: The overall fee for this programme is €1,800. Applicants in employment will qualify for 90% Springboard+ funding and the 10% fee to be paid will be €180. 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.

LIT 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 21-22 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***

Long Description

Quality Documentation, GMP & Data Integrity is a 20 credit special purpose award at level 7. The aim of this Certificate is to provide the skills necessary to work in the areas of quality control, quality assurance, manufacturing and auditing 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 GMP, quality documentation and data integrity to maintain a compliant system throughout the product lifecycle.

The Certificate is composed of 3 modules

1.Good Manufacturing Practice (GMP): The principles of GMP, cGMP, Regulations for the pharma, biopharma & medical devices sectors.
2.Quality Documentation: Good Documentation Practice (GDP), document control and Electronic Document Management Systems
3.Data Integrity: Data integrity principles, standards and control for physical and electronic data management systems

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
Assessments 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.

Timetable Info

TBC. September 2021 - May 2022

Delivery Location

Online

Delivery Notes

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 resources

Admissions Contact Details
Contact Person

Sinéad Liston

Address

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

Phone

+353 61 293026

Email

springboard@lit.ie

RPL Information

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

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
3. Proof of nationality ie. passport
4. Proof of employment/social welfare/returner status dated within the last month (see below)

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. LIT 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 €180 to secure their place on the programme. This 10% fee is non-refundable and must be paid before commencement date.

EMPLOYED APPLICANTS: ONE of the following: A recent payslip / most recent P60 / revenue documentation letter from employer confirming this (amounts may be redacted from financial documents) / letter/email from employer / proof from company website etc. Dated within the last month.

UNEMPLOYED APPLICANTS: Proof of social welfare: Written confirmation from the Department of Employment Social Protection (DEASP) that you are a Social Welfare recipient at the commencement of the course. Name of payment. Receipt from Post Office may suffice. Dated within the last month.

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. Download here and have completed by Peace Commissioner (no charge) or Commissioner of Oaths.

FORMERLY SELF-EMPLOYED: Provide a letter/statement from Revenue stating that the applicant is no longer trading or a similar letter from the applicants (former) accountant should be sufficient.

EXAMS: Continuous assessment assignment and projects will be set during the programme and/or
final online exam.

Please note that the exams for this course can 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 €1,800. Applicants in employment will qualify for 90% Springboard+ funding and the 10% fee to be paid will be €180. 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.

LIT 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 21-22 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***