Regulatory Training for Advanced Therapy Medicinal Products (ATMPs): Understanding Manufacturing and Inspection Practices

Certificate

Sonraí an Chúrsa

Course Code	SG_SNBMR_S09
Céim	9
Fad ama	1 semester
Creidmheasanna	5
Modh Seachadta	Blended
Suímh campais	Sligo
Modh Seachadta	Páirtaimseartha

Iarratas a dhéanamh

Regulatory Training for Advanced Therapy Medicinal Products (ATMPs): Understanding Manufacturing and Inspection Practices

Iarratas a dhéanamh

Forbhreathnú Cúrsa

This programme aims to equip the learners with a comprehensive understanding of ATMP manufacturing workflows and the critical points to assess during facility inspections.

This blended course of two days of theory and NIBRT onsite practicals/workshops combines theoretical sessions blending comprehensive knowledge of ATMP production processes, aseptic procedures, equipment, and QC practices with hands-on practical sessions and mock inspections to prepare participants to identify regulatory compliance issue effectively and ensure product safety and quality within ATMP facilities.

Additionally, it caters to regulatory specialists and quality control personnel who play pivotal roles in ensuring compliance and operational excellence within the evolving landscape of ATMPs.

Sonraí an Chúrsa

Bliain 1

Seimeastar	Sonraí an Mhodúil	Creidmheasanna	Éigeantach / Roghnach
1	Regulatory Training for Advanced Therapy Medicinal Products (ATMPs): Understanding Manufacturing and Inspection Practices This module aims to equip the learners with a comprehensive understanding of ATMP manufacturing workflows and the critical points to assess during facility inspections. This blended course of 2 days of theory and NIBRT onsite practicals/workshops combines theoretical sessions blending comprehensive knowledge of ATMP production processes, aseptic procedures, equipment, and QC practices with hands-on practical sessions and mock inspections to prepare participants to identify regulatory compliance issue effectively and ensure product safety and quality within ATMP facilities. Additionally, it caters to regulatory specialists and quality control personnel who play pivotal roles in ensuring compliance and operational excellence within the evolving landscape of ATMPs. Torthaí Foghlama 1. Analyse and assess the core components of ATMP development, including production workflows and equipment, while applying an advanced understanding of relevant GMP standards. 2. Apply knowledge of aseptic processing, transfer techniques, and cell culture operations to evaluate compliance. 3. Demonstrate critical insight into the selection and application of analytical and microbiological techniques used in the quality assurance of ATMPs. 4. Collate a structured aide memoire tailored to inspecting ATMP manufacturing facilities.Manage mock inspections effectively, focusing on identifying compliance gaps and ensuring adherence to regulatory standards. 5. Demonstrate expertise in navigating facility audits, inspections, and deviation handling, simulating real-world manufacturing challenges.	05	Mandatory

Uaireanta Staidéir Molta in aghaidh na seachtaine

3 hours per week

Scrúdú agus Measúnú

Theory: 30%
Lab Report: 40%
Reflective Report on Learning Applied to own employment (1500 words): 30%

Riachtanas Tinrimh ar an gCampas

For this Special Purpose Award students are required to attend two days in NIBRT at their state-of-the-art
facilities in Dublin. This represents week one. A time limit of 12 months is applied from NIBRT mandatory
attendance until completion of additional learning online via ATU for the Special Purpose Award. Students can
access this SPA any time in either semester 1 or semester 2 and the results will be brought to the next
available exam board.

Dul chun cinn

Students could progress by completing another Special Purpose Award or Level 9 major award in a related area.

Download a prospectus

Réamheolaire Iarchéime Online, Flexible and Professional Development Prospectus

Riachtanais Iontrála

The programme is open to students who have completed a minimum of a 2.2 Honours Level 8 degree in a Science or Engineering subject related to the life sciences.

Táillí

Total Fees EU: €500

€500 fee is paid directly to NIBRT via a payment link that will be sent post registration. If you have received a funding subsidy, you will be sent a payment link for the adjusted amount owed.

Tuilleadh eolais faoi tháillí

Gairmeacha

This course is specifically designed for regulatory professionals involved in the inspection and oversight of ATMP manufacturing facilities. It is ideal for inspectors, auditors, and compliance officers who need to deepen their understanding of ATMP workflows and gain practical tools for ensuring adherence to GMP standards. Additionally, it caters to regulatory specialists and quality control personnel who play pivotal roles in ensuring compliance and operational excellence within the evolving landscape of ATMPs.

A new report from the Expert Group on Future Skills Needs forecasts that 21,000 additional jobs are likely to be created in the Biopharma sector in Ireland by 2027. The report, entitled ‘Skills for Biopharma – Researching and forecasting the current and future skills needs of the Biopharma sector in Ireland to 2027’ shows the strong growth in employment in the Biopharma sector in both manufacturing and services subsectors in Ireland since 2016, and highlights the specific skills needed to support this dynamic and strategically important sector for Ireland’s economy. This report highlights that microcredentials for BioPharma training are an opportunity for skills enhancement.

Further Information

Cé Ba Chóir Iarratas a Dhéanamh?

This course is ideal for inspectors, auditors, and compliance officers who need to deepen their understanding of ATMP workflows and gain practical tools for ensuring adherence to GMP standards.