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 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

 

February Delivery
Online Theory - 20th & 21st
Full course - 20th & 21st (online theory) + 27th & 28th (onsite practicals)

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

September Delivery
Online Theory – 05th & 06th
Full course - 05th & 06th (online theory) + 12th & 13th (onsite practicals)

November/December Delivery
Online Theory - 27th & 28th November

Full course - 27th & 28th November (online theory) + 04th & 05th December (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:
  • 06/12/2022 - 07/12/2022
  • 06/12/2022 - 13/12/2022
  • 20/02/2023 - 21/02/2023
  • 20/02/2023 - 28/02/2023
  • 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
View Course

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

March Delivery
Online Theory - 13th & 14th
Full course - 13th & 14th (online theory) + 21st & 22nd (onsite practicals)

 

September Delivery
Online Theory – 11th & 12th
Full course - 11th & 12th (online theory) + 18th & 19th (onsite practicals)

December Delivery
Online Theory - 06th & 07th 

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

 

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

Dates:
  • 12/12/2022 - 13/12/2022
  • 12/12/2022 - 15/12/2022
  • 13/03/2023 - 14/03/2023
  • 13/03/2023 - 22/03/2023
  • 11/09/2023 - 12/09/2023
  • 11/09/2023 - 19/09/2023
  • 06/12/2023 - 07/12/2023
  • 06/12/2023 - 13/12/2023
View Course

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:
  • 14/12/2022 - 15/12/2022
  • 01/03/2023 - 02/03/2023
  • 15/06/2023 - 16/06/2023
  • 14/09/2023 - 15/09/2023
  • 06/12/2023 - 07/12/2023
View Course

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:
  • 26/01/2023
  • 23/02/2023
  • 23/03/2023
  • 20/04/2023
  • 25/05/2023
  • 22/06/2023
  • 21/09/2023
  • 26/10/2023
  • 23/11/2023
View Course

Gene therapies have the power to transform the lives of patients and provide cures to diseases that up till now had few or no treatment options. The processes for manufacturing these therapies require similar technologies to other biologic manufacturing processes but also have unique challenges and issues. This course will provide a background to the underlying concepts of gene therapy, including viral vector-based therapies and nuclease-mediated gene editing. In addition, practical hands-on sessions will introduce the technologies that are commonly used for the manufacture of these ground-breaking products. This includes technologies for the culture of suspension and adherent cells as well as downstream purification of the gene therapy products.

Course Delivery Method: Blended online and onsite training

  • One morning online theory
  • Two days NIBRT practicals

Course Costs: 

  • One morning online theory only: €600
  • Full course of One day online theory and Two days NIBRT Practicals €2,375

Dates:

Online Theory - 30 January 2023

Full Course - 30 January 2023 (online theory) + 02 & 03 February 2023 (onsite practicals)

 

This course is designed for anyone who has a general understanding of biopharmaceutical manufacture but would like to learn more about the concepts underlying gene therapy and the associated manufacturing methods.

Dates:
  • 30/01/2023
  • 30/01/2023 - 03/02/2023
View Course

This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on Data Integrity, a key enabler of reliable data.
Training material will include Data Integrity core concepts such as ALCOA+, Data and
Records Lifecycle Management, and impact of poor data practices.

This course is hands-on with case studies and scenarios challenging the learner to
understand:

  • how actions and activities can make/break data reliability efforts
  • how to examine systems and records in the NIBRT laboratory /or
    manufacturing suite
  • how to assess data integrity controls

Recurring and emerging inspection observation examples including FDA Warning
letters and 483s will be discussed, and how risks associated with data often occur
but could have been avoided. References to 21 CFR part 11 and Annex 11 will be
included to enhance understanding of the regulatory landscape. Management of raw
data and original records will be described across the data lifecycle with some
practical solutions, and the learner identifying if ALCOA+ attributes are delivered.
As technology solutions continue to expand and improve more traditional manual
processes we will also examine the challenges associated with the introduction of
new systems/technology and how these must comply with existing regulations.
The importance of a Data Integrity culture of excellence will be shown with examples
of how to escalate potential issues before they can negatively impact the patient.

New to the organisation or requiring refresher data integrity training with an understanding of the current regulatory landscape.  QA, QC, R&D, Validation, Metrology, C&Q, QMS, Manufacturing, Supply Chain, IT.

Dates:
  • 08/02/2023
View Course

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:
  • 09/02/2023 - 10/02/2023
  • 08/06/2023 - 09/06/2023
  • 05/10/2023 - 06/10/2023
View Course

This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on Risk Management.

When discussing risk in relation to data, which includes both paper based records and automation of ‘GxP’ processes resulting in electronic records, a common pitfall is to get the context wrong. For example, “What is the risk of this machine failing?” has an unclear context and does not directly link back to the patient.
Inspection observations continue to cite ‘ lack of appropriate measures’ …, taken when issues relating to QC data are identified but the product has already been released. Risk assessments associated with such critical issues need a focussed and adequate approach to mitigate further patient risk - we will help to walk you through this process.
In this course we will also explore what a catastrophic event means to Patient Health, Product Quality and Data Reliability and discuss some examples of realised risks with unbounded downsides.
We will use practical examples to understand risk subjectivity and how to optimise creative inputs for best data outcomes whilst effectively managing group biases.

Learners will have to complete tasks and be part of

  • small team risk sprint workshop
  • examine ICH Q9 R1 and the Risk Management Lifecycle
    ○ how to leverage formality
    ○ how to manage subjectivity
  • determine risk management and oversight controls for data and automation

Typical team risk challenges examine how data must be reviewed by QA departments, including: computerised records stored in the cloud/shared drives.

The use of data maps to identify data at risk will be showcased with learners getting hands-on experience of uncovering risks in a challenging cross functional setting.

New to the organisation or part of the site QRM team with an understanding of the current regulatory landscape. QA, IT, Validation, QRM champions.

Dates:
  • 09/02/2023
View Course

This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on Application Lifecycle Management (ALM). The impact of GAMP 5 Revision 2 and Computer Software Assurance (CSA) as it applies to validation will inform classroom discussions and how efforts are becoming increasingly commensurate with risk. 

And in case you are unsure of what ALM means to your GxP processes and records - ‘Ensuring a system remains 'fit for purpose' to meet the intended business need and deliver reliable data’

We examine what happens when you cannot gain access to your data, cannot read it or cannot migrate it to a newer application? and what regulatory observations and findings continue to highlight poor ALM.
We look at how poor Application Lifecycle management can just creep up on you (and if there were any warning signs?)
You will learn to identify during work sessions how

  • software with limited/no updates cannot sustain business processes
  • outdated software is considered by vendors ‘unmaintained’
  • software develops a bug and how it impacts data records and results
  • software can fall prey to cyber-attacks on the company network when patching is ‘patchy’
  • how a move from on premise to cloud based solutions needs to consider ALM of each solution and its risk to data/records

The final course work session will help you to identify and map out the points where
an application becomes not fit for purpose and ultimately leads to unreliable data.

New to the organisation or requiring more advanced topic understanding in relation to GxP applications lifecycle management. QA, CSV, Manufacturing, IT

Dates:
  • 13/02/2023
View Course

In this course we examine how Stakeholder Engagement directly impacts Data Reliability and when badly managed leads to poor data outcomes. IT projects are extremely costly to your organisation therefore getting stakeholder engagement right also leads to better business outcomes, IT cost reductions, and improved data integrity.
Unfortunately, inspection observations continue to highlight how a lack of stakeholder engagement across an organisation will lead to a dis harmonised data integrity culture, and likely lead to disparate processes and poor management of data and systems.
Stakeholder meetings can be complex, with different priorities, SME knowledge,
levels of interaction with the application and influence. However, if the project is to be a success and data to be reliable all stakeholders need to be satisfied.

During the numerous stakeholder workshops you will:

  • gain confidence in the benefits of creativity and difference perspectives
  • learn the first steps to achieving Stakeholder Engagement
  • recognise and manage a group with inherent bias

To help improve stakeholder engagement you will also be presented with several examples of both good and bad stakeholder engagement, allowing you opportunities to work together in different stakeholder roles whilst applying innovative tools.

New to the organisation or requiring more advanced topic understanding in relation to GxP applications lifecycle management. QA, CSV, Manufacturing, IT

Dates:
  • 14/02/2023
View Course

The course by Pro-Reliability Solutions is designed to interactively teach participants how to develop proactive asset management strategies for bio processing equipment through the application of best practice Reliability Engineering principles.

Participants will explore the application of Root Cause Analysis, Asset Maintenance Strategy Optimisation, Strategy Simulation, and Work Management practices to make optimised maintenance and reliability decisions.  With access to the on site suite of biopharma manufacturing process equipment, a practical exercise is also undertaken by the class to incorporate reliability principles and methods.

 

Course delivery method: 2 days onsite in NIBRT

Note:

*Asset Maintenance Strategy simulation software training licenses will be provided by PRS for the duration of the training

*Classroom location/ facilities and computer access for each participant will be provided by NIBRT

 

This workshop is of particular interest to organisations looking to improve the reliability of their manufacturing assets, and the efficiency and effectiveness of their existing asset management strategies and maintenance plans. The course may be of particular interest to:

  • Engineering, Director/Manager/Lead
  • Plant Engineering, Director/Manager/Lead
  • Bio Process Engineering, Director/Manager/Lead
  • Bio Process, Director/Manager/Lead/Engineer/Specialist
  • Maintenance, Director/Manager/Lead/Engineer
  • Reliability, Director/Manager/Lead/Engineer
  • Operations, Director/Manager/Lead
  • Tech Operations, Director/Manager/Lead
  • Engineering Specialist / Senior Specialist
  • Manufacturing Biotech Associate (including senior/lead roles)

 

Dates:
  • 22/2/2023 - 23/2/2023
View Course

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:
  • 02/03/2023 - 03/03/2023
  • 05/10/2023 - 06/10/2023
View Course

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
March Delivery
Online Theory - 22nd, 23rd & 24th
Full course - 22nd, 23rd & 24th (online theory) + 28th & 29th (onsite practicals)

September Delivery
Online Theory - 20th, 21st & 22nd
Full course - 20th, 21st & 22nd (online theory) + 26th & 27th (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:
  • 22/03/2023 - 24/03/2023
  • 22/03/2023 - 29/03/2023
  • 20/09/2023 - 22/09/2023
  • 20/09/2023 - 27/09/2023
View Course

A two-day course focused on the application of basic statistics and visualisation in biopharma manufacturing. Suitable for trainees with no or limited mathematical/statistical background, including manufacturing specialists, lab staff, process scientists and IT professionals.

Course Delivery Method:  Fully onsite.

Day 1

Morning: Introduction to statistics, the concept of probabilities and measures of central tendency, normal distribution, outlier identification.

Afternoon: Practical - Data summarisation from a bioprocess

Day 2

Morning: Effective visualisation for discrete and continuous data

Afternoon: Practical: Continuation – generating various visuals for reporting

For trainees with no or limited mathematical/statistical background, including manufacturing specialists, lab staff, process scientists and IT professionals.

Dates:
  • 23/03/2023 - 24/03/2023
View Course

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

 

April Delivery
Online Theory - 17th , 18th & 19th   
Full course - 17th , 18th & 19th  (online theory) + 25th & 26th (onsite practicals)

September Delivery
Online Theory - 04th , 05th & 06th   
Full course - 04th , 05th & 06th  (online theory) + 11th & 12th (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:
  • 17/04/2023 - 19/04/2023
  • 17/04/2023 - 26/04/2023
View Course

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:
  • 17/04/2023 - 21/04/2023
  • 09/10/2023 - 13/10/2023
View Course

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: €950 
  • Full course of Two days online theory and Three days NIBRT Practicals €3800

 

 April/May Delivery
Online Theory - 24th & 25th April
Full course - 24th & 25th April (online theory) + 03rd, 04th & 05th May (onsite practicals)

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

Dates:
  • 24/04/2023 - 05/05/2023
  • 24/04/2023 - 25/04/2023
View Course

A three-day course designed to build on the introductory course (Introduction to Data Analytics for Biopharma Manufacturing).

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:
  • 24/04/2023 - 26/04/2023
View Course

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: 3 Days Blended Online and Onsite in NIBRT

  • One morning online theory
  • Two days NIBRT practical

Course Costs:

  • One morning online theory only: €600
  • Full Course of One morning online theory and Two days NIBRT Practicals: €2375

Course Dates:

  • Online Theory - 08 May 2023
  • Full course - 08 May 2023 (online theory) + 11 & 12 May 2023 (onsite practicals)

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:
  • 08/05/2023
  • 08/05/2023 - 12/05/2023
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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:
  • 08/05/2023 - 09/05/2023
  • 07/09/2023 - 08/09/2023
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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:
  • 29/05/2023 - 30/05/2023
  • 02/10/2023 - 03/10/2023
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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:
  • 19/06/2023 - 23/06/2023
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