Short Training Courses

NIBRT provides a wide range of short training courses covering all aspects of biopharma manufacturing.

The short courses consist of lectures which can be delivered online or in a classroom setting, and practical sessions which are delivered in NIBRT's state-of-the-art facility. 

Current NIBRT Training Courses

This course will introduce maintenance and reliability engineers within the biopharmaceutical industry who have limited experience with vibration analysis.

This 2-day classroom course, in collaboration with Emerson, will provide learners with hands-on experience in NIBRT’s Clean and Black Utilities plant rooms and guidance from Emerson’s Reliability and Machinery Health Expert with over 20 years’ experience.

Participants will learn about the causes of vibration and methods of measurement. We will also look at assets that are commonly monitored in this industry, detailing which points to measure, how, and why by looking at real-life assets within NIBRT’s Clean and Black Utilities Plants.

Participants who complete the 2-day course will receive a certificate of completion from Emerson.

Delivered By: Sjors van Noorloos, Senior Machinery Health Management Engineer, Emerson Automation Solutions.

This course is suitable for:

Maintenance and reliability engineers in the biopharmaceutical industry with limited experience with vibration analysis

Dates:
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This interactive tour of the 4.0 Biopharmaceutical "Facility of the Future" will provide an immersive educational experience in how cutting-edge technologies such as robotics, artificial intelligence (AI), virtual reality (VR) and augmented reality (AR) can revolutionise manufacturing operations, technical learning and quality assurance.  The tour will be hosted by Industry 4.0 experts from Boston Consulting Group (BCG) and the 4.0 team at NIBRT.  There will be opportunity for open discussions on topics such as investment and steps for implementation.

Delivery Method:  0.5 day onsite in NIBRT.

Please contact us at  training@nibrt.ie to request more information on scheduling this course.

Manufacturing, quality and site organization managers and engineers who are looking to increase their understanding of and learn how to apply the latest digital trends and technologies in biopharma. 

Data science & analytics engineers within biopharma who want to assess the latest 4.0 technologies.

People who are new to Industry 4.0 who are looking for a “taster” of the available technologies.

Dates:
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This intensive one and a half day course provides an introduction to the operation of DeltaV™ distributed control system within a biopharmaceutical batch manufacturing environment.  This course will include both hands-on practical and theory components.  During this course trainees will be introduced to the principles of process automation and control using DeltaV™ DCS.  Topics include: Navigating DeltaV™, Alarm and Event Management, Batch Operation and Troubleshooting.  Trainees will gain hands on practical experience working with stainless steel and disposable bioreactor systems within DeltaV™.  Trainees will prepare, run and troubleshoot a simulated large scale cell culture bioprocess.

Course delivery method: Fully onsite in NIBRT

If you would like to book a place on this course please contact us at training@nibrt.ie

This course is designed for operators, technical staff, engineers and managers wishing to improve their operational knowledge of DeltaV™ DCS within a biopharmaceutical manufacturing environment.

Dates:
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This comprehensive 3-morning course is designed to equip biopharma manufacturing and quality personnel with advanced knowledge of how biopharma companies can use cutting edge technologies such as robotics, artificial intelligence (AI), virtual reality (VR) and augmented reality (AR) to revolutionise manufacturing operations.  The course will include an overview of biopharma 4.0; digital immersion deep dives; and demos and case studies of how the technologies can be applied across manufacturing, quality and organizational excellence.

Course Delivery Method:  Fully online.

  • Three mornings online

If you would like to book a place on this course please contact us at training@nibrt.ie

Biopharma 4.0 is aimed at manufacturing, quality and site organization managers and engineers who are looking to increase their
understanding of and learn how to apply the latest digital trends and technologies in biopharma.
Data science & analytics engineers within biopharma who want to assess the latest 4.0 technologies.

Dates:
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As Pharma 4.0 brings with it a shift toward digitalisation, more and more businesses are implementing digital calibration processes. Evolving technology has meant that life science businesses can now do more with, and learn more from, their process data than ever before.

Identify the key points that you need to consider when preparing your business to transition from traditional manual calibration processes to automated digital processes. Enable yourself to better manage and utilise data and ensure that you remain compliant with the various regulatory requirements in the life science sector.

Learn what impact digital calibration processes may have on the future of the life science sector and how you can utilise these processes to the benefit of your business.

This talk is aimed at individuals working in the life science sector who want to better understand the changing trends related to calibration within their industry.

You may be:

  • Focusing on improving traceability, data integrity or efficiency within your process.
  • Exploring better, more modern, or more efficient methods of work.  
  • Considering if your business should implement a digital calibration process. If so, why should you do this? And how do you start?
  • Looking to better understand what considerations you should take on board when trying to transition your business from a traditional, manual calibration process, to an automated digital process.
  • Interested in learning how digital platforms and technology have evolved over the years, to better enable businesses to remain compliant and meet regulatory requirements such as FDA’s 21 CFR part 11.

Content will cover:

  • The need to remain compliant with GXP, GMP, and FDA regulatory requirements.
  • Ensuring compliance relating to GAMP, ALCOA, Quality Systems, ISO17025, Calibration systems and the shift towards digitalisation
  • Future systems relating to industry 4.0, IOT, robotics, automation, big data, and AI

Course Delivery Method: Morning classroom session and afternoon practical session

Course Delivered By: Sami Koskinen and Michael Frackowiak (Beamex)

Price: €999

 

 

This course is suitable for:

Maintenance managers, continuous improvement managers, innovation managers, engineering managers, digitalisation managers, quality managers, E,C & I Lead or a reliability representatives

Dates:
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Stem Cell Therapy is an area of increasing investigation and investment as a treatment option for patients with a previously unmet clinical need.

This training programme, presented as a collaboration between the Centre for Cell Manufacturing Ireland (CCMI) and NIBRT, will cover all aspects of stem cell therapy manufacture.  It will allow trainees to gain hands on experience of cell vial thaw, initial seeding, expansion and cryopreservation as well as the associated equipment required to carry out these tasks.   In addition, trainees will gain insight into the morphology of stem cells and indications of cell culture contamination, allowing them to identify and troubleshoot potential issues.  The important aspect of QC, both micro and analytics, will also be demonstrated during the course.

4.5 Days Onsite in NIBRT

If you would like to book a place on this course please contact us at training@nibrt.ie

This course is designed for those that have some knowledge of cell culture techniques but would like to specifically learn how stem cell therapy manufacture is conducted.  This course would be ideally suited to graduates with a cell culture background or cell culture technicians from a biologics manufacturing setting.

Dates:
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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:
  • 15/09/2021 - 16/09/2021
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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:
  • 13/10/2021 - 14/10/2021
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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: €1,320
  • Full course of Three mornings online theory and Two days NIBRT practicals: €3,080

 

 

September Delivery
Online Theory - 05th, 06th & 07th
Full course - 05th, 06th & 07th (online theory) + 12th & 13th (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:
  • 05/09/2022 - 07/09/2022
  • 05/09/2022 - 13/09/2022
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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: €880 
  • Full course of Two mornings online theory and Two days NIBRT Practicals €2640

 

 

June Delivery
Online Theory - 14th & 15th
Full course - 14th & 15th (online theory) + 21st & 22nd (onsite practicals)

September Delivery
Online Theory – 06th & 07th
Full course - 06th & 07th (online theory) + 13th & 14th (onsite practicals)

December Delivery
Online Theory - 06th & 07th
Full course - 06th & 07th (online theory) + 12th & 13th (onsite practicals)

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:
  • 06/09/2022 - 07/09/2022
  • 06/09/2022 - 14/09/2022
  • 06/12/2022 - 07/12/2022
  • 06/12/2022 - 13/12/2022
View Course

Cellular Immunotherapy is a subset of Advanced Therapy that uses cells of the immune system to treat diseases such as cancer. The most well-known type of Cellular Immunotherapy is CAR-T; a treatment that uses genetically modified immune cells (T cells) to target and kill cancerous cells.

This course will provide a description of the theory underlying CAR-T as well as other Cellular Immunotherapy modalities, including CAR-NK, TILs, and cancer vaccines. In addition, the course will describe the difference between autologous and allogeneic forms of these therapies as well as the associated advantages and disadvantages of each approach. The manufacture of these therapies will also be discussed as well as key QC requirements and the difficulties associated with ensuring quality product.

In addition to the theoretical learning, significant time will be spent working with cells in a Cellular Immunotherapy manufacturing workflow. Trainees will interact with equipment associated with all steps of the manufacturing process, from cell thaw (controlled thaw of Leukopak) through to cell isolation (density gradient centrifuge), modification and expansion (rocker bioreactor), purification (centrifuge), and cryopreservation (controlled rate freezer).

2 Days Onsite in NIBRT

Early Bird Offer - Book September course before 29th July to avail of 10% early bird discount.

This course would benefit anyone who already has an understanding of biopharmaceutical manufacture but would like to gain some further insight into the manufacture of cell therapies, in particular, cellular immunotherapy.

Dates:
  • 06/09/2022 - 07/09/2022
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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:
  • 15/09/2022 - 16/09/2022
  • 14/12/2022 - 15/12/2022
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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: €880
  • Full course of Two mornings online theory and 2 days NIBRT Practicals: €2640

 

 

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

Dates:
  • 19/09/2022 - 20/09/2022
  • 19/09/2022 - 22/09/2022
  • 12/12/2022 - 13/12/2022
  • 12/12/2022 - 15/12/2022
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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:
  • 19/09/2022 - 20/09/2022
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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

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

Dates:
  • 22/09/2022
  • 20/10/2022
  • 24/11/2022
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This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on four key reliability enablers – Data Integrity, Risk Management, Stakeholder Engagement and Application Lifecycle Management (ALM). 

Training material will include Data Integrity core concepts such as ALCOA+, Data and records Lifecycle Management, Impact of poor data practices and multiple learning case studies and scenarios challenging the trainee to understand how actions and activities can make/break data reliability efforts.

Inspection observation examples including FDA Warning letters and 483s will be examined and data risk areas discussed during learner work sessions.  References to 21 CFR part 11 and Annex 11 will be included to enhance understanding of the regulatory landscape. The importance of a Data Integrity Culture of excellence will be discussed over the two days. There will be multiple test yourself opportunities and a short assessment to benchmark your learning.

 

Early Bird Offer - Book September course before 19th August to avail of 10% early bird discount.

This course is particularly well suited to those new to pharma or Biopharma or who are currently working within the Life Sciences area and wish to improve their understanding of data reliability and integrity . It will be relevant right across an organisation and in particular to those working in Quality, Manufacturing, Supply Chain and IT and related disciplines such as validation and metrology. No experience is necessary although experienced data practitioners will still gain from the multiple scenario-based learning opportunities.

 

Dates:
  • 26/09/2022 - 27/09/2022
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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: €1,320
  • Full course of Three mornings online theory and Two days NIBRT practicals: €3,080
 

October Delivery
Online Theory - 03rd, 04th & 05th
Full course - 03rd, 04th & 05th (online theory) + 06th & 07th (onsite practicals)

  • 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:
  • 03/10/2022 - 05/10/2022
  • 03/10/2022 - 07/10/2022
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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:
  • 19/10/2022 - 20/10/2022
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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

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:
  • 22/11/2022 - 24/11/2022
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