Training Courses

This advanced one-day course is tailored to introduce participants to the concept of real-time process control in a GMP environment. The course is designed to be hands-on and will make use of GMP-ready software provided by Qubicon. To attend this course, participants are expected to have intermediate mathematical/statistical skills and a good understanding of MES systems. Join us on this immersive training session and equip yourself with the skills necessary to succeed in real-time process control. 

Onsite (1 day): Date to be confirmed

Morning: Introduction to real-time process control 

Afternoon: Practical – Implementing a process control strategy in a GMP environment 

Fee: € 950 

To attend this course, participants are expected to have intermediate mathematical/statistical skills and a good understanding of MES systems.

The course is targeted towards bioprocess engineers and scientists, cell culture engineers and scientists, USP/DSP (Upstream Processing/Downstream Processing) process development engineers and scientists, fermentation engineers and scientists, as well as data engineers and scientists.

Dates:

Springboard 2023 Intake. 

Dates:

Vaccines play a vital role in human health and the defence against infectious diseases. Awareness of the importance of vaccines has never been as high as during the COVID-19 pandemic. This course aims to give a general overview of the various vaccine modalities; from live or attenuated viruses to recombinant protein and DNA/mRNA-based vaccines. This course will also describe the various methods of manufacture of these different vaccines from upstream to downstream to fill-finish and quality control. Furthermore, practical sessions will allow the trainee to work with the equipment used in these manufacturing processes and gain hands-on experience of the associated techniques.

Course Delivery Method: 5 Days Blended Online and Onsite in NIBRT

• Two days online theory
• Three days NIBRT practicals

Course Costs:

• Two days online theory only: €1900
• Full course of Two days online theory and Three days NIBRT Practicals €4750

Course Dates:  The course is available for delivery on request for groups of 6-10. If you are interested, please get in touch at training@nibirt.ie 

This course is designed for operators, technical staff, engineers, and managers wishing to increase their knowledge of the strategies used in vaccine manufacturing.

Dates:

Springboard 2023 Intake. 

Dates:

Springboard 2023 Intake. 

Dates:

This 3.5 day course is designed to equip QC Microbiology analysts with the main theory and practical experience required to develop their skills in a GMP biopharmaceutical microbiology laboratory.  The course will cover microbiology basics in the classroom-based lectues and lab-based practical sessions, including Growth Promotion Testing and BI Processing, Environmental Monitoring, Water Sampling, Bioburden and Sterility testing (using rapid methods) & Endotoxin testing (using recombinant Factor C technology, Microbial Identifications, and Virus and Mycoplasma testing.   The course will also cover data trending and an overview of how to approach deviations and investigations.

Course delivery method: Blended Online and Onsite at NIBRT

• Three mornings online theory
• Two days NIBRT practicals

Course Costs:

• Three mornings online theory only: €1,425
• Full course of Three mornings online theory and Two days NIBRT practicals: €3,325

• QC Micro personnel looking for a refresher or introduction to the relevant theory and practical elements of common microbiology lab tests.
• Lab management personnel who want to refresh their knowledge on testing protocols and regulatory requirements. 
• QA, Manufacturing or Engineering personnel who have an invested interest in what happens in a QC Micro lab.

Dates:

• 22/03/2023 - 24/03/2023
• 22/03/2023 - 29/03/2023
• 20/09/2023 - 22/09/2023
• 20/09/2023 - 27/09/2023

This 2-day intensive course presented by invited industry experts will cover industry practices and regulatory expectations and trends in cleaning and cleaning validation.  It is designed for biopharmaceutical manufacturers who are concerned about developing or maintaining a high-quality, efficient, and most importantly, compliant cleaning process. The training will address several current challenges to cleaning and validation in the biopharmaceutical industry, and include case studies, best practices, and hands on exercises using state-of-the-art bioprocessing equipment located in the NIBRT facility. 

Personnel from Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, Plant Management disciplines.

Dates:

• 11/04/2023 - 12/04/2023
• 03/10/2023 - 04/10/2023

This course will provide an introduction to the theory and practice of biopharmaceutical lyophilisation.  It will first introduce learners to the key principles of lyophilisation before focusing on its use in the context of sterile fill-finish manufacturing.  What are the critical process parameters to consider during a fill finish operation of a lyophilised biologic?  How do these relate to critical quality attributes?  How does formulation impact on the process?  These questions and others will be considered during the course which will be delivered through a combination of classroom lectures and workshops supported by hands-on practical sessions with our pilot-scale lyophiliser (Lyobeta 3PS), fill finish line and  other supporting equipment.

Course delivery method: Fully onsite in NIBRT

Bioprocessing Operators working in the fill finish and lyophilisation space and anyone who wants an introduction to the concept and principles of biopharmaceutical lyophilisation in the context of sterile biopharmaceutical fill-finish operations.  Experience working in an aseptic processing environment would be an advantage but is not required to attend this course.

Dates:

• 08/05/2023 - 09/05/2023
• 07/09/2023 - 08/09/2023

This course provides an introduction to the typical upstream operations carried out in a biopharmaceutical manufacturing facility. This course will include both hands-on practical and theory components covering cell vial thaw, aseptic techniques, cell counting, metabolic analysis, scale up, and bioreactor operation.  Equipment such as single-use rocking bioreactors stirred-tank reactors, as well as stainless steel reactors, will all be utilised to reflect the current state of biopharmaceutical manufacturing technology. 

This course is designed for operators, technical staff, engineers and managers wishing to increase their knowledge of the upstream operations in a modern bioprocessing plant.

Course Delivery Method: Blended online and onsite training

• Two mornings online theory
• Two days NIBRT practicals

Course Costs:

• Two mornings online theory only: €950 
• Full course of Two mornings online theory and Two days NIBRT Practicals €2850

This course is designed for operators, technical staff, engineers and managers wishing to increase their knowledge of the upstream operations in a modern bioprocessing plant.

Dates:

• 06/06/2023 - 07/06/2023
• 06/06/2023 - 14/06/2023
• 05/09/2023 - 06/09/2023
• 05/09/2023 - 13/09/2023
• 27/11/2023 - 05/12/2023
• 27/11/2023 - 28/11/2023

This two-day course provides an introduction to the typical Commissioning, Qualification, and Validation (CQV) concepts and activities employed in a modern biopharmaceutical manufacturing facility. The course will include both hands-on practical and theory components, introducing topics such as CQV, Process Validation Lifecycle, Validation Risk Analysis, FAT/SAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Continuous Process Verification & Automation systems. Equipment such as stainless-steel bioreactors, utilities skids, and mobile vessels, along with Piping & Instrumentation Diagrams (P&IDs) and a tour of NIBRT’s Utilities and Pilot plant will be utilised to provide an understanding of how CQV concepts are applied to biopharmaceutical production facilities

2 Days Onsite in NIBRT

This course is designed for operators, technical staff, engineers, managers, and graduates wishing to gain an introductory knowledge of Commissioning, Qualification, and Validation activities in the Biopharmaceutical Industry.

Dates:

• 08/06/2023 - 09/06/2023
• 05/10/2023 - 06/10/2023

This course is designed to deliver an introduction to the typical downstream operations used in a biopharmaceutical production process. This course includes both hands-on practical and lecture components covering topics such as harvest, ultrafiltration/diafiltration, viral clearance and chromatography. During this course trainees will be introduced to the basics of filtration and chromatography in a theory session before building on this knowledge and performing these operations using a practical component.
Suitable for: operators, technicians, engineers & managers.

This course is designed for those that are new to downstream processing including operators, technical staff, engineers and managers who need to increase their basic knowledge of actual operations in a modern downstream processing biopharma plant.

Course delivery method: Fully onsite in NIBRT

This course is designed for those that are new to downstream processing including operators, technical staff, engineers and managers who need to increase their basic knowledge of actual operations in a modern downstream processing biopharma plant.

Dates:

• 15/06/2023 - 16/06/2023
• 14/09/2023 - 15/09/2023
• 06/12/2023 - 07/12/2023

This is a unique training course for pharmaceutical auditors who will audit against pharmaceutical Good Manufacturing Practice (GMP) and/ or audit suppliers to pharmaceutical manufacturing sites.  The course trains auditors how to professionally plan, perform, report and follow-up internal and supplier audits and is set in a pharmaceutical context throughout the whole course.

Our GMP Auditor/Lead Auditor Course is aimed at internal and supplier auditors along with key personnel involved in Quality Assurance and Quality Management Systems.  The course will also benefit those involved in the purchasing of incoming materials and individuals who look after the whole supply chain.  Additionally, the course is ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no forma auditor training.  The course may be used as part of Continual Professional Development (CPD) of many quality professionals.

Dates:

• 19/06/2023 - 23/06/2023

The aim of this course is to introduce the biopharmaceutical industry and its associated processing principles and techniques to Engineers from a non-biopharma background. The course will expand attendees knowledge and understanding of all aspects of the bioprocessing industry. This online theory course introduces the biopharmaceutical industry and the main processes including upstream, downstream and fill finish operations.  This course includes interactive virtual tours of the NIBRT training facility. 

The course is offered in association with Engineers Ireland.

Course delivery method: Fully online

Next course 22 June 2023

Anyone working in the (bio)pharma and related industries who wish to further their understanding of all aspects of biopharma manufacturing.

Dates:

• 22/06/2023
• 21/09/2023
• 26/10/2023
• 23/11/2023

An immersive two-day course dedicated to the practical application of basic statistics and visualisation techniques in the biopharmaceutical manufacturing industry. Designed especially for trainees who are new to data analytics and possess limited or no background in statistics, this comprehensive course aims to equip participants with essential skills for effectively handling and interpreting bioprocessing data.

This course will explore the fundamentals of statistics and introduce the concepts of probabilities as applicable to bioprocessing. Practical, hands-on sessions on bioprocess data summarisation and visualisation are a key component of this course. These interactive sessions will prepare trainees to gain a better insight on their data and allow for improved data-driven communication with colleagues.

Who Should Attend: The typical profiles of trainees are manufacturing specialists, quality control analysts, process scientists and IT professionals with responsibility in business intelligence (BI) tools deployment.

Key topics covered:

Day 1:

In the morning session, we will begin with an accessible introduction to statistics, emphasising the concepts of probabilities and measures of central tendency. You will gain a firm understanding of the normal distribution and learn techniques to identify and handle outliers effectively.

The afternoon will be dedicated to hands-on practice, where you will learn how to summarise bioprocess data efficiently. Through interactive sessions, you will gain practical experience in data summarisation techniques, enabling you to extract valuable insights from your datasets.

Day 2:

On the second day, the morning session will focus on mastering the art of effective data visualisation for both discrete and continuous data. You will be introduced to various visualisation methods that are highly relevant to the biopharma manufacturing sector.

Continuing from the morning, the afternoon session will provide further practical experience as you generate and interpret a range of visuals for comprehensive data reporting. These interactive sessions will empower you to communicate your findings more effectively with your colleagues, promoting data-driven decision-making within your organisation.

Manufacturing specialists, quality control analysts, process scientists and IT professionals with responsibility in business intelligence (BI) tools deployment.

Dates:

• 04/09/2023 - 05/09/2023

This 3.5 day course guides trainees through the Critical Quality Attributes of biologics (ICH Q6B) as well as core analytical platforms routinely employed in a QC testing environment in order to measure them.  Using a combination of lecture sessions online followed by hands-on practical training, the course will cover methods such as electrophoretic separations (capillary electrophoresis, slab gels), HPLC/UPLC methods (peptide mapping, SEC, etc), and immuonassays (ELISA).

Course delivery method:  Blended online and onsite training

• Three mornings online theory
• Two days NIBRT practicals

Course Costs:

• Three mornings online theory only: €1,425
• Full course of Three mornings online theory and Two days NIBRT practicals: €3,325

September Delivery
Online Theory - 04^th , 05^th & 06^th   
Full course - 04^th , 05^th & 06^th  (online theory) + 11^th & 12^th (onsite practicals)

This course is suitable for graduates seeking to gain entry into the area of biopharma QC, those currently working in QC/QA (small molecule or large), those working in product or process development/characterisation or anyone looking to increase and expand their understanding of QC testing for biologics and biosimilars.

Dates:

• 04/09/2023 - 06/09/2023
• 04/09/2023 - 12/09/2023

This programme is designed to provide an introduction to current aseptic techniques related to working in an aseptic filling environment. This blended programme provides both a theoretical introduction to contamination control, environmental monitoring, filter integrity testing and filling systems, while also allowing trainees hands-on interaction with both isolator and RABs units while conducting glove integrity tests, media fills and troubleshooting. An introduction to Grade B gowning will also be included in the programme.

Course delivery method: Blended online and onsite training

• Two mornings online theory
• Two Days NIBRT Practicals

Course Costs:

• Two mornings online theory only: €950
• Full course of Two mornings online theory and 2 days NIBRT Practicals: €2,850

• Manufacturing
• QA/QC
• Engineering Technicians
• Specialists
• Operators

Dates:

• 11/09/2023 - 12/09/2023
• 11/09/2023 - 19/09/2023

This comprehensive 2-day course equips participants with the knowledge and skills needed to successfully transition from paper-based manufacturing to electronic batch record systems. 

Participants will delve into the intricacies of EBR implementation, focusing on identifying relevant data sources, adhering to regulatory requirements, and bridging the knowledge gap among stakeholders. Through interactive sessions, trainees will learn user requirement specification and proof-of-concept deployment, gaining hands-on experience in process mapping, instrument set up, and QA review.

Course delivery method: 2 days onsite at NIBRT  - The course is available for delivery on request for groups of 6-10. If you are interested, please get in touch at training@nibrt.ie 

Key Topics Covered:

• Where to start with EBR and eForms: Understanding the fundamentals and key considerations for implementing EBR systems.
• EBR Design best practices: Exploring industry-leading approaches to designing effective EBR systems.
• Implementing EBR and eForms: Hands-on exercises and practical guidance for successfully deploying EBR and eForms.
• Sustaining EBR and eForms: Strategies and insights for maintaining and optimising EBR systems in the long run.

Enrol in the "Electronic Batch Record (EBR) and eForms" course at NIBRT and gain the confidence and expertise needed to drive successful EBR implementation.

This course is ideal for individuals responsible for or interested in electronic batch record implementation, including professionals in quality assurance (QA), manufacturing, and information technology (IT). It is also highly recommended for newcomers to electronic (paperless) manufacturing systems and those planning to transition from a paper-based to a paperless system within their manufacturing sites.

Dates:

• 13/09/2023 - 14/09/2023

This one-day course is crafted to offer non-experts a journey into the transformative world of Biopharma 4.0 principles, shedding light on the key concepts, tools, and future trends that are revolutionising the sector.

Key Topics Covered 

• Electronic batch record and eForms 
• Overview of data analytics 
• Future trends in biopharma digitalisation 

Course delivery method: 1 day onsite at NIBRT

Individuals working in IT, lab informatics, process operators and engineers, manufacturing scientists, who wish to gain a broader understanding of Biopharma 4.0 and how it can help manufacturing operations. 

Dates:

• 22/9/2023

A three-day course designed to build on the introductory course (Introduction to Data Analytics for Biopharma Manufacturing). This comprehensive program is designed to equip participants with the advanced skills and knowledge required to excel in the field of data analytics within the biopharma manufacturing industry.

Throughout this course, participants will explore various essential topics, gaining a deeper understanding of data science and its applications in biopharma manufacturing. The course will be delivered fully onsite, providing an immersive and engaging learning experience.

Course Delivery Method:  Fully onsite.

Day 1

Morning: Reproducibility in data science: Infrastructure, documentation, and version control (Git) Linear and non-linear regression: Combining chemistry and bioprocess knowledge with statistical modelling, pitfalls of relying solely on single metrics Afternoon: Practical: Data analysis for stability testing and cell culture/purification

Day 2

Morning: Design of Experiments: Benefits of DoE over one-factor-at-a-time (OFAT) experiments, types of DoE designs, continued integration of process knowledge for DoE Afternoon: Practical: Designing an experiment for cell culture/purification

Day 3

Morning: Statistical Process Control (SPC): Control charts and process capability Afternoon: Practical: Trending of manufacturing and quality control data

For trainees with a good basic statistical knowledge, including process and quality control scientists.

Dates:

• 25/09/2023 - 27/09/2023
• 11/12/2023 - 13/12/2023

Single Use Technology is widely used within the biopharmaceutical industry and has quickly become a mainstay within the sector.  This training programme will highlight the readily available technologies that can be implemented in upstream and downstream processing.  It will allow trainees to gain hands on experience of common disposable technologies used in upstream and downstream processing including bioreactors, chromatography systems, UFDF systems, connects/disconnects and tube welders and sealers.

Course delivered: Fully onsite in NIBRT

This course is designed for those that are new to the use of single use technologies, including development scientists, process engineers, and manufacturing operators.  It is expected that attendees will have a basic knowledge of the manufacturing process prior to attending course.

Dates:

• 02/10/2023 - 03/10/2023

This one-day course, provided in collaboration with Lachman Consultants (Ireland), provides an insightful understanding of expectations and successful approaches to implementation of the revised Annex 1. The sessions will focus on aseptic manufacturing compliance, including Annex 1 requirements, developing of implementation strategics, maturity assessment and planning for sustainable improvements.

Taught by highly experienced practitioners, the training will provide exposure to methodology to assess compliance and maturity of the current state.  The course leads the learners through basic principles to more advanced consideration and shares commonly used approaches.  The course will cover key topics related to aseptic manufacture and compliance requirements.

The course will also share recent non-compliance trends and common challenges faced by aseptic manufacturing and provide the opportunity to discuss assessment or implementation challenges.

Key Topics Covered

• Environment classification and Standards (ISO and Grades A, B and C)
• Room Qualification (static and dynamic)
• Aseptic Process Simulation
• Key elements for Developing a Contamination Control Strategy
• Opportunity to discuss Industry challenges.

Operations, Quality Assurance VP, Directors & Snr Mangers / Audit Directors / Corporate Audit teams

Dates:

• 04/10/2023

This course serves as an introduction to the category of medicines known as Advanced Therapy Medicinal Products, often commonly referred to as Cell and Gene Therapies.  Over two days, trainees will learn about what these therapies are, how they work, current manufacturing techniques, and possible future trends.  They will learn about viral vectors, nucleases, and the wider field of gene therapy as well as cellular immunotherapies and stem cells.  In addition, they will learn how companies ensure the quality of these products.

They will also get an opportunity to use the specific cell culture and downstream purification equipment that is commonly used to manufacture these products.  This equipment includes adherent and suspension cell culture systems such as controlled rate thawers, cell factories, rocker bioreactors, fixed bed bioreactors, and single-use stirred tank reactors.  It also includes harvest and downstream equipment such as centrifuges, depth filtration systems, single-use chromatography system, single-use ultrafiltration systems, and controlled-rate freezers.

Course delivery method: Fully onsite in NIBRT

Anyone who has a basic knowledge of the biopharmaceutical industry and would like to learn more bout this expanding field of therapeutics.

Dates:

• 05/10/2023 - 06/10/2023

This course is designed to introduce the biopharmaceutical industry and the main biopharmaceutical manufacturing operations to attendees.  This course introduces the typical upstream, downstream and fill finish operations carried out in a biopharmaceutical manufacturing facility.  The course will expand attendees' knowledge and understanding of all aspects of the bioprocessing industry. 

This online theory course will be delivered over 5 morning sessions, and cover topics such as cell culture and upstream processing, aseptic techniques, bioreactor operation, harvesting, chromatography, filtration, and filling operations and will include interactive virtual tours of the NIBRT training facility.

The course is offered in association with Engineers Ireland.

Course delivery method: Fully online

This course is designed for technical staff, engineers and managers wishing to increase their knowledge of the operations in a modern bioprocessing plant.

Dates:

• 09/10/2023 - 13/10/2023

This course provides both classroom and laboratory instruction within cell therapy processes and cell manufacturing under good manufacturing practice (GMP) procedures.  Divided into upstream, cell expansion, and downstream applications, practical laboratory sessions will provide beginning-to-end technical knowledge and training on industry standard equipment and reagents.  Guidance to Standard Operating Procedures (SOP) development will also be discussed.  Templates for SOPs are provided upon request.

Course delivery method: Fully onsite at NIBRT by Cytiva Trainers

Course Costs: € 3,450 

Dates:  07 - 09 November, 2023 

** for more info :

For more info: Advanced cell therapy (CELLT2) | Cytiva (cytivalifesciences.com)

This training course will be useful for research and development scientists, process engineers, and manufacturing technicians.  A basic understanding of cell culture and corresponding techniques is required for this course.

Dates:

• 07/11/2023 - 09/11/2023

Cell Therapy is a term used to describe therapies whereby living cells are introduced into a patient to achieve a therapeutic benefit.  In Europe, they fall under the category of ATMPs and, depending on how they are modified, some may be approved as ex vivo gene therapies (e.g. CAR-T).

This course will provide an overview of the different classes of cell and cell-based therapies including Mesenchymal Stem/Stromal Cell Therapies, Pluripotent Stem Cell Therapies, CART-T Cell Therapies, CAR-NK Cell Therapies, as well as other types of Cellular Immunotherapy.  

In addition to the theoretical content concerning biology, mechanism of action, manufacturing methods, and quality control for these therapies, much time will be given to hands-on practice of techniques and operation of equipment used to produce these therapies commercially.  This hands-on practical training will use state-of-the-art automated systems to showcase the current and potential future manufacturing techniques available.

Course Delivery Method: 

• Two and a half  days onsite at NIBRT 

Course Costs:

• Full Course Two and a half  days onsite at NIBRT: €2375

Course Dates:

• Full course - 06 - 08 December 2023

This course is ideal for anyone with an existing knowledge of biopharmaceutical processes and is looking to increase their knowledge of the expanding areas of cell and cell-based therapies.

Dates:

• 06/12/2023 - 08/12/2023