Expand+QQI Level 6 award, or equivalent qualification in business/engineering or science, and/or relevant life and work experience. Applicants may also be eligible for entry according to LIT’s Recognition of Prior Learning procedures.

ENGLISH LANGUAGE:...

Hide-QQI Level 6 award, or equivalent qualification in business/engineering or science, and/or relevant life and work experience. Applicants may also be eligible for entry according to LIT’s Recognition of Prior Learning procedures.

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.

Expand+The aim of the Certificate in Regulatory Affairs and Quality is to provide the basic skills necessary to work in the area of Quality especially regulatory affairs within the (bio) pharmaceutical/medical devices and other related industries. It provid...

Hide-The aim of the Certificate in Regulatory Affairs and Quality is to provide the basic skills necessary to work in the area of Quality especially regulatory affairs within the (bio) pharmaceutical/medical devices and other related industries. It provides an ideal upskilling opportunity for quality personnel and also enables cross-skilling of production personnel planning for a career in quality assurance. This certificate will be delivered online.

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.

Expand+What modules will I study?

Content
The programme comprises of three modules.

Semester 1: Sept- Dec

Quality Assurance and Validation
Key principles of a quality assurance system within a cGMP environment will be discussed. The importance a...

Hide-What modules will I study?

Content
The programme comprises of three modules.

Semester 1: Sept- Dec

Quality Assurance and Validation
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.

Cleanroom Management
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.

Semester 2: Jan-May

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.