Munster Technological University (MTU) is a teaching, learning and research institution of excellence and quality which provides inclusive access to education for students with varied aptitudes, needs and experience across a wide range of disciplines and award levels. MTU's main aim is to provide student-centred education with a career focus for the benefit of the personal, intellectual and professional development of the student and for the benefit of the whole of society.
Provides valuable knowledge and key skills pertinent to working in the highly regulated manufacturing environments such as GMP, Quality and Validation for up-skilling and cross-skilling purposes.
Understand the principles that underpin working within a regulated manufacturing environment Understand the importance, implementation and impact of validation and regulatory in the Pharma/Biopharma/Medtech industries. Examine the regulatory requirements of validation, identify and discuss the industry standard guidelines in use. Assess the principles of validation and a range of strategies used in its application. Apply a range of risk management tools in making regulatory based decisions.
This course is in partnership with Regional Skills and industrial partners (Pharma/Biopharma/Medtech) and UCC in response to the skills gap identified by the manufacturing companies in Validation. This course consists of two modules delivered over one academic year which is delivered completely online; videos of material content, industry-led workshops and webinars delivered by the industrial partners online, online submissions of continuous assessments.
Dr Caroline O'Sullivan is a lecturer in Department of Process Energy and Transport Engineering and lectures on the Chemical and Biopharma Degree programme (Level 8 BEng) (Validation Science and Process Technology Transfer modules). She has significant industrial experience working in roles related to process and product development in the Pharma and Medical Device Industries.
One academic year: September to May
Assessment & certification
100% continuous online assessments
Special Purpose Award Certification in validation Science (Level 7- NFQ) - MTU
Who should attend
Individuals with a level 6 qualification seeking to up-skill/cross-skill for purposes of joining, re-entering or for career progression in the Biopharma, Pharma and MedTech sectors.