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

Certificate

Course Details

Course Code	SG_SNBMR_S09
Level	9
Duration	1 semester
Credits	5
Method of Delivery	Online
Campus Locations	Sligo
Mode of Delivery	Part Time

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

Apply Now How to Apply

Course Overview

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.

NIBRT Global Qualification (NGQ)

The NIBRT Global Qualifications (NGQs) are internationally recognised training qualifications setting a new benchmark for biopharmaceutical education and workforce development.

Earn your NGQ by completing a micro-credential accredited by ATU – a short, flexible and accredited way to upskill and advance your biopharma career.

Step 1 – Complete an upstream practical training course at the NIBRT facility or at an affiliated NIBRT Global Partner site.
The upstream practical training module provides students with a fundamental understanding of both the theoretical and practical aspects of cell culture processing as it relates to the manufacture of modern biopharmaceutical products.

Step 2 – Register for the corresponding NGQ below for €500. To earn the qualification, you will complete a multiple-choice quiz, a 2,000-word lab report, and a 1,500-word reflective assessment. Upon successful completion, you will receive your accredited NGQ certificate (5 ECTS). NGQs are stackable, leading to a Special Purpose Award (30 ECTS).

Fee Payment: €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.

Course Details

Year 1

Semester	Module Details	Credits	Mandatory / Elective
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. Learning Outcomes 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

Recommended Study Hours per week

3 hours per week

Examination and Assessment

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

On-Campus Attendance Requirement

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.

Progression

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

Download a prospectus

Postgraduate Prospectus Online, Flexible & Professional Development Prospectus

Entry Requirements

To be eligible, applicants must have completed the Mandatory Practical attendance for this module with NIBRT within the previous 12 months.

Fees

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.

Further information on fees

Careers

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

Who Should Apply?

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.