Quality Documentation, GMP & Data Integrity (L7, 20 ECTS)

Status: Register Your Interest (Sept-23)

Level

Duration

1 Year

Department

Applied Science

Start Date

TBC

Course Type

Flexible & Professional

Location

Online

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.

What are the entry requirements?

Applicants should have a Higher Certificate in Business, Engineering or Science at level 6. Applicants may also apply for Recognition of Prior Learning.

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. It is the responsibility of the applicant to ensure their English proficiency meets these requirements.

Who can I contact?

What modules will I study?

Quality Documentation: Good Documentation Practice (GDP), document control and Electronic Document Management Systems

GMP: The principles of GMP, cGMP, Regulations for the pharma, biopharma & medical devices sectors.

Data Integrity: Data integrity principles, standards and control for physical and electronic data management systems

Are there opportunities for further study?

This Certificate, along with the Certificate in Regulatory Affairs & Quality and the Certificate in Quality Management & Statistics can be combined to make up the add on Bachelor of Science in Quality (Level 7).

More Information

Delivery

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

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.

Assessment

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

Qualification

Certificate in Quality Documentation, GMP and Data Integrity (Special Purpose Award, Level 7, 20 Credits)

Application Deadline

TBC for Sept-23

For queries relating to the course

Email: Springboard@lit.ie

For academic queries

Contact: Dr Tracey Larkin
Email: Tracey.Larkin@lit.ie

Contact: Siobhan Curtin
Email: Siobhan.Curtin@lit.ie

Course Fees

Full Fees: €1,900. TBC for Sept-23

This programme is 90% Springboard funded for employed applicants and 100% Springboard funded for unemployed applicants in 2022.

Please see here for eligibility criteria details.

Please see this link for further course details: https://springboardcourses.ie/details/9111

Click here for all Flexible Learning Policies and Procedures

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 2014-2021