Commissioning Qualification & Validation for Biologics Manufacturing (CQV)
The importance of biopharmaceuticals as a portion of total pharmaceutical revenue continues to expand, with ?40% of overall pharmaceutical industry R&D and products in the development pipeline being biopharmaceuticals. Nonetheless, significant challenges remain in the sector such as the fundamental complexity of bringing new therapeutics to market, reimbursement and pricing models, Brexit uncertainties and global skills shortages. Notwithstanding these challenges, the Irish biopharma sector has continued its strong performance in attracting foreign direct investment. As validation of the capabilities available in Ireland, companies with existing operations here such as MSD, BioMarin and AbbVie have all made significant new biopharma investments. An objective of this new postgraduate certificate programme in CQV is to help support new facilities and extensions with commissioning, qualification and validation work before manufacturing can commence. The focus shall be on facilities and equipment.
This programme is jointly offered by IT Sligo and NIBRT (National Institute for Bioprocessing Research and Training).
About this programme
It is the overall aim of this postgraduate course to deliver training which is customised to meet the exact needs of the clients in the biopharma sector. This is achieved through completing online modules that have been designed in conjunction with the Biopharma industry with whom NIBRT and IT Sligo are closely aligned. The proposal here is to offer a new additional online postgraduate level 9 certificate programme with a focus on CQV for biologics manufacturing. Further to discussions with our industry partners, it is envisaged that this programme will appeal to those who wish to advance their career while engaging in study that may be beneficial to their employer. The programme will address a knowledge gap amongst junior CQV engineers that don't have a specific engineering background in areas such as hygienic pipework principles, P&ID walkdowns, instrumentation and calibration. Equally, the programme will address engineering focused CQV engineers where a good grounding in regulations and compliance would be very beneficial, based on industry feedback.
It is also envisaged that this programme will provide an attractive progression pathway for Level 8 graduates who wish to undertake Level 9 studies with an interest in employment in the biologics industry. An objective of this new postgraduate certificate programme in CQV is to help support new facilities and extensions with commissioning, qualification and validation work before manufacturing can commence. The focus shall be on facilities and equipment.
Students study 15 credits per semester. Students are required to complete a total of 30 credits for the full award.
Facility Design and Operation 05
Biologics Manufacturing 05
Regulation, Risk and Compliance 05
Commissioning, Qualification & Validation 10
Scale-up and Technology Transfer 05
The programme is open to students who have obtained an honours degree (Level 8) or its equivalent in an appropriate discipline (i.e. Engineering or Life Sciences). Other candidates with alternative honours degrees and relevant experience in the BioProcessing industry (typically 5 years duration in a GMP environment) may apply for consideration through the IT Sligo RPL (Recognised Prior Learning) process.
Applicants whose first language is not English should provide evidence of English language proficiency.
Application Closing Date : 31st August 2022
1 year part-time.
Post Course Info
Upon successful completion of this programme students can progress onto the L9 BioPharmaceutical Science suite of programmes.