Training Courses

Training Courses

NIBRT provides a “one stop shop” for the bioprocessing Industry’s training requirements. We provide a dynamic catalogue of course content from which we build unique training solutions for our Clients.

These solutions range from operator training through to the senior management training and can be delivered in a variety of formats to suit each client’s requirements. Our aim is to deliver holistic training programmes in a realistic GMP simulated, operational manufacturing environment.

Please contact training@nibrt.ie with any queries you may have.

Download the NIBRT Training Catalogue

Current NIBRT Training Courses

This three day 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.

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

Dates:
  • 17/02/2020 - 19/02/2020
  • 25/05/2020 - 27/05/2020
  • 20/07/2020 - 22/07/2020
  • 21/09/2020 - 23/09/2020
  • 14/12/2020 - 16/12/2020
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This program is open only to those accepted on the Springboard 2020 programs. ( Please note you will have received a confirmation email that you have been enrolled on this program).

Please do not proceed to course deposit unless you have received confirmation that you have been successfully enrolled on this program.

The springboard+ upskilling initiative in higher education offers free courses at certificate, degree and masters level leading to qualifications in areas where there are employment opportunities in the economy. For more information please go to springboardcourses.ie

This is only open to those accepted on Springboard 2019 programs subject to the applicant meeting all requirements, e.g. academic requirements.

Dates:
  • 17/02/2020
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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. The course is offered in association with Engineers Ireland.

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

Dates:
  • 20/02/2020
  • 26/03/2020
  • 22/04/2020
  • 21/05/2020
  • 25/06/2020
  • 23/07/2020
  • 27/08/2020
  • 24/09/2020
  • 22/10/2020
  • 26/11/2020
  • 17/12/2020
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This comprehensive 2-day 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 and augmented reality to revolutionise manufacturing operations. The course will include an on overview of biopharma 4.0; digital immersion deep dives; and demos and case studies…

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:
  • 07/05/20 - 08/05/20
  • 15/10/20 - 16/10/20
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Dates:
  • 18/04/2020
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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 system, UFDF systems, connects/disconnects and tube welders and sealers.

 

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:
  • 05/05/2020 - 06/05/2020
  • 03/09/2020 - 04/09/2020
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A Critical Quality Attribute (CQA) of a drug is defined as a ‘physical, chemical, biological, or microbiological property…that should be within an appropriate limit…to ensure the desired product quality’ (ICH Q8 (R2)).  For biopharmaceuticals and biosimilars, these include properties such as amino acid sequence, post-translational modifications, intact mass and higher-order structures, biological activity, process and product related impurities and stability, among many others.  With such physicochemical complexity informing drug S&E, many orthogonal techniques are required for robust and unequivocal quality data.

This three-day course guides trainees through the CQAs 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 and hands-on practical training, the course will cover methods such as electrophoretic separations (capillary electrophoresis, slab gels), HPLC/UPLC methods (peptide mapping, SEC, etc), nanoDSF (label-free nanoscale Differential Scanning Fluorimetry) and immunoassays (ELISA).

We would like to thank NanoTemper Technologies for the provision of their label-free nanoscale Differential Scanning Fluorimetry instrument, Prometheus NT. 48, for this training course. Click here to find out more about Nanotemper Techologies.

 

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:
  • 06/05/2020 - 08/05/2020
  • 06/10/2020 - 08/10/2020
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This one-day course is designed to provide the trainee with a brief introduction to microbiology and its practical application in a GMP biopharmaceutical manufacturing environment. Classroom-based lectures and hands-on practical sessions will introduce the aseptic practices of environmental monitoring and water sampling as well as the use of common microbiology lab equipment such as BSCs, microscopes and gram staining equipment.

Course Attendee

“ I found the layout of the course excellent with great practical subjects. The areas of most interest to me was environmental monitoring and the water sampling system. A great deal of material was covered for a one day course. The course was really useful for someone like me who does not have a pure science background. This course would be excellent for anyone with a basic understanding of scientific terminology working in sales to biopharma companies or a person working in biopharma hoping to transfer in an area of quality”

 

New recruits to QC who are looking to familiarise themselves with the theory and practical elements of standard Micro testing.
Lab management personnel who want to refresh their knowledge on testing protocols and requirements.
QA, Manufacturing or Engineering personnel who have an interest in what happens in the laboratories.

Dates:
  • 06/05/2020
  • 01/09/2020
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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.

 

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:
  • 11/05/2020 - 15/05/2020
  • 21/09/2020 - 25/09/2020
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This two day course provides an introduction to the typical upstream operations carried out in a biopharamaceutical manufacturing facility. This course will include both hands-on practical and theory components. During this course trainees will be introduced to cell culturing techniques using small scale shake flasks. Trainees will then gain hands on practical experience using both stainless steel and disposable bioreactor systems. Trainees will prepare and run a steam in place cycle on a stainless steel bioreactor and then inoculate a production batch into a stainless steel bioreactor.
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.

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:
  • 18/05/2020 - 19/05/2020
  • 13/07/2020 - 14/07/2020
  • 14/09/2020 - 15/09/2020
  • 07/12/2020 - 08/12/2020
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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 ultrafiltration/diafiltration, viral clearance and chromatography. During this course trainees will be introduced to the basics of UF/DF 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.

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.

Dates:
  • 20/05/2020 - 21/05/2020
  • 15/07/2020 - 16/07/2020
  • 16/09/2020 - 17/09/2020
  • 09/12/2020 - 10/12/2020
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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.

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:
  • 09/06/2020 - 11/06/2020
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This comprehensive 3-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 as an introduction to the remaining classroom-based lectures and lab-based practical sessions, including Growth Promotion Testing and BIs, Environmental Monitoring and Water Testing, Microbial Identifications, and Adventitious Agents testing.  The course will also cover a regulatory overview of micro lab requirements as well as how to approach common lab deviations.

  • 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:
  • 09/06/2020 - 11/06/2020
  • 29/09/2020 - 01/10/2020
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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:
  • 22/06/2020 - 26/06/2020
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Our Biotech training course discusses and interprets the cGMP requirements for each step involved with process development, validation, control, auditing, and effective quality assurance (QA) and quality control (QC).  We run process simulations and have detailed discussions that promote understanding about risk assessment, deviation investigation and batch dispositioning.  This course also provides a unique insight into assuring GMP for biological products when working alongside experts in the field across a complex process train.

This course is designed to support EU Qualified Persons as part of their QP application or as a valuable, highly focused continuing professional development event.  NSF designed the course to give production, QA, QC and technical services staff detailed insight into the challenges of producing and testing biotech and biological pharma products.

Dates:
  • 14/07/2020 - 17/07/2020
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This one-day intensive course will provide a detailed insight into the history, current trends, regulatory requirements, and methodologies of Thermal Validation.

Course Instructor:

Dennis Plante is the Senior Validation Market/Product Specialist for Kaye instruments located in Billerica MA.   With his engineering background and his 37+ years with Kaye Instruments, Dennis has a deep understanding of the applications, regulatory requirements and process technologies related to Thermal Validation.

Validation engineers and managers wishing to further their understanding of all aspects of Thermal Validation.

Dates:
  • 15/10/2020
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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:
  • 28/10/2020 - 29/10/2020
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