Regulated New Product Introduction for the Bio Pharmaceutical Industry - Cork

The Postgraduate certificate in Regulated New Product Introduction (NPI) & Technology Transfer is designed to develop students to support the rapid, efficient, compliant NPI & technology transfer process in heavily regulated environments such as that of the biopharmaceutical and pharmaceutical sectors.



The programme is aimed at those who wish to develop their technical and transversal skills to support the transfer of new pharmaceutical and biopharmaceutical products in and out of manufacturing facilities while operating in a GxP regulated environment. It is suited for those employed or seeking employment within the pharmaceutical, biopharmaceutical and life-science sectors.



The Postgraduate Certificate in Regulated New Product Introduction for the (Bio)pharmaceutical Industry has been co-developed between the Engineering faculty at MTU and a number of Biopharmaceutical & Pharmaceutical industry partners, as part of the iEd Hub suite of industry-facing programmes.



Teaching will be delivered in a blended format to allow for high flexibility with a mixture of live online lectures and self-directed learning. On this course you will complete 30 credits (5 modules) part-time over 3 semesters.



This Postgraduate Certificate in Regulated New Product Introduction is a minor award of the Master of Science in Regulated New Product Introduction & Technology Transfer and students who complete this course can transfer into the Masters course. https://www.mtu.ie/courses/crernpi9/

Modules Semester 1

CHEP9005 Quality, Validation & Risk Management - 10 Credits

CHEP9004 Lifescience Project Management - 5 Credits



Modules Semester 2

CHEP9007 Analytical Technology Transfer - 5 Credits

CHEP9008 Facilities & Utilities - 5 Credits



Modules Semester 3

CHEP9006 Operations Transfer Readiness - 5 Credits

Applicants who have a minimum of an Honours Bachelor of Science, Engineering or cognate degree (Level 8) or cognate discipline (H2.2) or equivalent from an accredited or recognised HEI provider or an approved qualification are eligible to apply for entry to the programme.



In exceptional cases applicants not meeting the above criteria will be considered for entry based on an interview and successfully demonstrating that they hold an equivalent professional qualification



All applicants whose first language is not English must provide evidence of English language proficiency (IELTS score of at least 6.5 with no section below 6.0). English language tests must be undertaken no more than two years prior to the start of the programme. Full English Language Requirements are available at https://www.mtu.ie/international/non-eu/cork-campus/



Places are limited. Applications are assessed on a first-come, first-served basis.



What is RPL?

Recognition of Prior Learning (RPL) is when formal recognition is given for what you already know prior to starting on a programme or module. With recognition of prior learning the focus is on learning and not on experience as such. You can apply for RPL in any MTU accredited programme or module. Programmes which are accredited by professional bodies or any external awarding bodies may have their own procedures for RPL which you should refer to.

Application Deadline

17th January 2025

Teaching will be delivered in a blended format to allow for high flexibility with a mixture of live online lectures and self-directed learning. On this course you will complete 30 credits (5 modules) part-time over 3 semesters.

Start date: 20th January 2025

Career options

Biopharmaceutical, Pharmaceutical, Med-Tech. Life science industries.

The program is designed to provide an industry-guided skillset and entry route to/for the field of GxP technology transfer in the life science manufacturing sector.



It has two unique target streams:



To provide the necessary upskilling opportunities for existing employees already in the sector looking to move into multifunctional life science project teams. This includes existing scientific & engineering staff who may be experienced in the laboratory/production operations and routine commercial batch release who wish to progress into science & technology roles working more closely with R&D in bridging the transition to manufacturing. The role of the graduates could include Process Engineers, Principal/Senior Scientists and NPI Project Managers as examples.



To provide multidisciplinary skills necessary for the modern (Bio)pharmaceutical industry going forward, and so is relevant to graduates of cognate disciplines wishing to transition to this sector.



Progression

This Postgraduate Certificate in Regulated New Product Introduction is a minor award of the Master of Science in Regulated New Product Introduction & Technology Transfer and students who complete this course can transfer into the Masters course. https://www.mtu.ie/courses/crernpi9/