Regulatory Affairs & Quality (Special Purpose Award, Level 7)
The aim of the Certificate in Science in Regulatory Affairs and Quality is to provide students with the basic skills necessary to work in the area of Quality within the pharmaceutical/biopharmaceutical/medical devices and other related industries, particularly in the Regulatory Affairs aspects of those industries.
The programme comprises of three modules.
In semester 1 there will be two modules:
Quality Assurance and Validation
The learner will be able to; explain the key principles of a quality assurance system; discuss the applications of quality assurance within the cGMP environment; describe the tools and techniques used for validation; and demonstrate the application of validation within the product life cycle.
The learner will be able to; identify sources of contamination and describe measures to minimise them; differentiate between different cleanroom types and cleanroom classes by FDA, EU and ISO cGMP standards; describe cleanroom operations; apply the principles of cleaning validation and develop cleaning validation protocols; and generate Standard Operating Procedures (SOPs) for cleanroom discipline and gowning.
In semester 2 the module will be:
Regulatory Affairs and Compliance Auditing
The learning will be able to; understand the relevant national and international regulatory standards/systems relating to the healthcare, pharmaceutical, medical devices and allied industries; demonstrate a specialised knowledge of the regulatory frameworks, ethical issues and vigilance in the healthcare, pharmaceutical, medical devices and allied and related industries; critically discuss current quality standards and potential quality improvement systems from a relevant industrial perspective; have a detailed knowledge and understanding of the purpose and requirements of the Quality Management System ISO standards in relation to auditing and the responsibilities of auditors; have a detailed knowledge, understanding and experience of the importance of internal and external auditing within a quality management system; and independently plan and conduct, analyse and report an effective audit.
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.
Programme Delivery Mode
This programme is delivered with a mixture of online and classroom delivery. Some of the content will be delivered online with the remaining involving either lectures/practicals/tutorials delivered at the LIT Moylish Park Campus, Limerick or LIT Clonmel Campus, Tipperary.
The modules in semester 1 and semester 2 will be assessed by a combination of Continuous Assessment and Final Examination papers.
EXAMS: 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)
Certificate in Regulatory Affairs & Quality, Special Purpose Award, Level 7, 20 Credits.
How to Apply
Applicants must apply for these programmes on the Springboard website.
“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 2014-2020.”