Training Catalogue 2017 - NIBRT - The National Institute

TRAINING CATALOGUE 2017

2017 Training and Education Catalogue

Contents Welcome letter

1 2 3 4 5 6 8 9 10

Training Facilities ........................................................................................................ 3 Customised Training Programmes .............................................................................. 4 Open Courses .............................................................................................................. 5 Masters Programmes .................................................................................................. 6 Major Award Programmes.......................................................................................... 7 Certificate Programmes .............................................................................................. 8 Springboard ................................................................................................................. 9 What Our Clients Say .................................................................................................. 9 NIBRT Awards............................................................................................................ 11

Note: All prices and course dates are correct at the time of publication but are subject to change, please refer to www.nibrt.ie for the most current information or contact us on [email protected] or + 353 1 215 8100. We look forward to working with you.

Please refer to www.nibrt.ie for full course details

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Dear Colleague, Welcome to NIBRT’s Training and Education Catalogue for 2017. NIBRT is an award winning institute based in Dublin, Ireland that provides training and research solutions for the biopharma industry in state-of-the-art facilities.

The NIBRT Building

NIBRT’s programmes are designed in partnership with industry to deliver flexible, competency based learning solutions that deliver immediate cost-effective benefits in the work place. Our training solutions can be customised to meet your requirements using the latest instructional design and online learning techniques to provide accelerated learning solutions. We offer trainees unrivalled access to a fully operational manufacturing plant, in a simulated GMP environment that ensures trainees gain hands-on experience with both the equipment and the regulations of a cGMP plant. Courses are designed to maximise trainees’ hands-on practical exposure to all equipment, with a trainee to instructor ratio of approximately 5:1. This catalogue summarises the wide variety of training and education solutions which we provide and we look forward to the opportunity of working with you in 2016. NIBRT Training Team NIBRT provides clients with an unrivalled opportunity to develop their biopharma knowledge, skills and experience in a safe, simulated GMP and cost-effective manner.


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1 Training Facilities

Trainees in the pilot plant control room

The NIBRT training facility (6,500 m²) is a purpose-built, multi-functional building which replicates the most modern industrial bioprocessing facility. At the heart of the NIBRT building is the bioprocessing pilot plant, consisting of extensive upstream, downstream, fill-finish, associated analytical facilities and process utilities. These facilities are all operated in a realistic GMP simulated, operational manufacturing environment.  

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Laboratory scale aseptic processing, cell bank, inoculum and protein purification suites. Upstream Suite: 1 x 30 litre and 2 x 150 litre stainless steel bioreactors and 200L single use STR, perfusion system, disc stack centrifuge, depth (stainless steel and single use) and microfiltration skids. Downstream Suite: 2 x ultrafiltration/diafiltration automated systems, 2 x automated process chromatography systems, automated column packing technologies, viral inactivation vessels and a number of integrity test stations. Fill-finish suite: a vial filling machine under LAF and RABS with associated preparation room and aseptic gowning room, a modular aseptic workstation with integral HPV biodecontamination. Manufacturing Support: Buffer and media preparation suites utilising both stainless steel and disposable technologies; equipment preparation including parts washer and autoclave. Central clean utilities suite including highly purified water, clean steam and CIP skids and clean air generating systems Suite of analytical laboratories for product and process characterization.


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2 Customised Training Programmes

A trainee in the NIBRT Fill Finish Suite

All NIBRT training can be customised to meet a Client’s requirements: Customised Content:

We will develop and implement course content to your specifications in order to replicate how operations, processes and procedures are applied in your organisation

Customised Scheduling:

We can organise training courses to suit your business priorities and work schedules

Customised Delivery:

NIBRT can deliver courses to clients via online learning or by on-site visits if required.


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3 Open Courses Open courses are short, intensive programmes which are focused on a particular topic. The current schedule1 for open courses for 2017 is shown below. Open Course Schedule 2017 Course Date Introduction to Bioprocessing for Engineers

Introduction to Continuous Chromatography

Fill Finish Operations

03/02/17 21/04/17 21/07/17 15/09/17 01/12/17 22/03/17

30/01/17 - 01/02/17 03/05/17 - 05/05/17 21/08/17 - 23/08/17 13/11/17 - 15/11/17 31/01/17 – 01/02/17

A Practical Introduction to Commissioning & Qualification 16/05/17 - 17/05/17 Commissioning and Qualification for New and Renovated Facilities 26/06/17- 30/06/17 Pharmaceutical Quality Management Systems (PQMS) Auditor/ Lead Auditor Training Course Upstream Processing Operations

Downstream Processing Operations

1.

24/01/17 - 25/01/17 24/04/17 - 25/04/17 15/08/17 - 16/08/17 07/11/17 - 08/11/17 26/01/17 - 27/01/17 26/04/17 - 27/04/17 17/08/17 - 18/08/17 09/11/17 - 10/11/17

Full courses details are available from: http://www.nibrt.ie/cat_training_schedule.jsp All prices and course dates are correct at the time of publication but are subject to change, please refer to www.nibrt.ie for the most current information or contact us on [email protected].


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4 Masters Programmes M.Sc. in Biopharmaceutical Science Summary: The post-graduate programme in biopharmaceutical science aims to provide students with a comprehensive grounding in critical aspects of biopharmaceutical processing and their support services, with specific focus on the product lifecycle of biopharmaceutical products and their associated processes. Duration: A part-time programme delivered by online learning which can be completed in a 2-3 year timeframe. Price: €12,000 (EU students) Accrediting body: IT Sligo M.Sc. in Bioprocess Engineering Summary: The M.Sc. is an interactive and dynamic programme that will develop your knowledge and appreciation of the conceptual and factual bases for bioprocess design and operation. It also develops your understanding of bioprocessing, particularly the structures, roles and experimental methods associated with biopharmaceuticals, their analysis, production methods and technology for monitoring and control of bioprocesses. Duration: The full-time programme is offered on a one year full time and up to 4 years parttime. Price: €6,272 (EU students) Accrediting body: Dublin City University M.Eng.Sc. in Biopharmaceutical Engineering Summary: This is an advanced postgraduate degree programme offering a combination of lectures, tutorials, practicals and project work delivered by university and industry experts. Duration: The full-time programme is completed in one year and the part-time programme can be completed over 2 or 3 years. Price: €7,040 (EU students) Accrediting body: University College Dublin

NIBRT’s Academic Partners


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5 Major Award Programmes

A trainee in the NIBRT upstream processing pilot plant

NIBRT’s major award programmes are delivered by online learning techniques. These programmes are accredited by the Institute of Technology Sligo including hands-on practical training in the NIBRT biopharmaceutical plant. BSc (Ordinary) in Biopharmaceutical Science Summary: The course is aimed at production, technical grade and supervisory / managerial staff and provides trainees with the skills necessary to work in a changing, highly regulated and technology driven manufacturing environment. Duration: 2 years part-time Accreditation: Level 7 (60 credits) Price: €7,200 BSc (Hons) in Biopharmaceutical Science Summary: This course is geared towards graduates who can assume positions of responsibility in the pharmaceutical industry. It is a broad based and multi-disciplinary course. Duration: 2 years part-time Accreditation: Level 8 (60 credits) Price: €9,000


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6 Certificate Programmes

NIBRT’S certificate programmes are short, accredited, training programmes that have been designed in association with our partners, Pfizer, Merck Sharp Dohme, Janssen Biologics and Eli Lilly and Co. These programmes focus on upskilling clients on the key competencies required in biopharma manufacturing. They are intensive programmes which are delivered via a blend of online learning and practical modules in the NIBRT facility.

Certificate in Science Credits 1 30

Price (€)

Certificate in Science in Cleanroom Manufacturing

30

€3,150

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Certificate in Science in Biopharmaceutical Processing

30

€4,950

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Certificate in Science in Bioprocess Engineering

30

€4,950

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Certificate in Science in Biopharmaceutical Processing

70

€6,300

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Certificate in Science in Biopharmaceutical Technologies

30

€6,300

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Certificate in Science in Biopharmaceutical Science

30

€6,000

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Title Certificate in Science in Biopharmaceutical Processing

€3,150

Level 6

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Note: 1. National Framework Equivalent (www.nfq.ie). Accredited by IT Sligo. 2. European Credit Transfer and Accumulation System (ECTS) grading system.


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7 Springboard The Springboard initiative in higher education provides an exciting pipeline of free training programmes for those who are currently seeking employment in Ireland. NIBRT is not yet inviting applications for the following Springboard programmes. Information will be updated shortly. Any queries on these programmes please contact [email protected]. National Framework Equivalent level, ww.nfq.ie 1.

All practicals are delivered in NIBRT


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9 What Our Clients Say

NIBRT training clients

“Continuous education, personnel development and up skilling are a key enabler to success in today's competitive environment. Finding the time for professional development and further education is hard in today's workplace. However, the programs that NIBRT & IT Sligo offer are of excellent value and greatly facilitate the balance between on-going education and demands of the work place. From personal experience, the Sligo IT / NIBRT distant learning programs are flexible, value add and industry friendly”. Merck Sharp Dohme (MSD), Fergal O'Donovan, Director, Technical Services “As someone coming from the small molecule industry with a Chemical Engineering degree I found the Masters in Biopharmaceutical Science very beneficial for understanding the fundamentals of Biotech manufacturing, the science, the equipment, the quality environment within which one must operate. The choice of modules and the content of those modules gave me a broad understanding of the entire Biotech business. The distance learning approach was a first for me but I found it very flexible, user friendly and above all else efficient when balancing work commitments. Overall an excellent experience.” Eli Lilly & Company, Martin Boyle, Downstream Ops, Team Leader Biotech

"We worked with NIBRT on numerous occasions, from training colleagues for the start-up of a new biologics facility (Production, QA, QC, Technical Services and the Senior Leadership team) to the up-skilling of some of our existing employees. In these projects NIBRT always worked with us in close collaboration and partnership to ensure that our exacting needs were met and that we benefited fully from their tremendous expertise in the area of biopharmaceutical manufacturing." Pfizer, Training Lead


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6 NIBRT Awards

ISPE/Interphex Facility of the Year Awards: Special Recognition for Novel Collaboration: The Facility of the Year program is the pharmaceutical industry’s premier awards program dedicated to celebrating innovation and accomplishments in facility design, construction, and operation. The Judging Panel cited that “…advancements in pharmaceutical manufacturing sometimes come through innovative collaborations like NIBRT that can ultimately lead to “game changing” outcomes”. Further Information: http://www.facilityoftheyear.org/foyawinners2012#NIBRT 2012 BioProcess International Awards — Winner of Manufacturing Collaboration of the Decade Award BioProcess International (BPI) has announced NIBRT as the winner of the Manufacturing Collaboration of the Decade Award. Further information: http://awards.bioprocessintl.com/ Prof Pauline Rudd, NIBRT awarded Center of Innovation Award from Waters Corp. Waters Centers of Innovation Program recognizes analytical scientists facilitating breakthroughs in health and life science research, food safety, environmental protection, sports medicine and many other areas. These leading scientists, in partnership with Waters, are using liquid chromatography and mass spectrometry to unlock the mysteries of science and take research down new and exciting paths. Further Information: http://www.waters.com/waters/nav.htm?locale=en_US&cid=134671201 Outstanding Achievement Award for MSD Training Programme with NIBRT and IT Sligo Merck Sharp Dohme (MSD)’s site in Brinny, Co. Cork was given an Outstanding Achievement Award for its innovative partnership programme with the National Institute for Bioprocessing Research and Training (NIBRT) and Institute of Technology, Sligo. Further Information: http://www.nibrt.ie/cat_news.jsp?i=151 Online Courses win Taoiseach’s Public Service Excellence Award NIBRT and IT Sligo, one of the leading providers of online courses in the country, has received a prestigious “Taoiseach’s Public Service Excellence Award” in recognition of its role in increasing access to higher education for part-time and distance learners through online delivery. Further information: http://www.nibrt.ie/cat_news.jsp?i=168&p=100&n=119&cat_p=0&cat=39


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Book a Training Course

NIBRT Reception

To register for a training course please complete and return the attached form. If you would like to discuss your training requirements further, please contact us at the details below. We look forward to hearing from you. John Milne Kate Cotter Bernadette Gallagher Killian O’Driscoll

NIBRT Training NIBRT Training NIBRT Training NIBRT Director of Projects

[email protected] [email protected] [email protected] [email protected]

National Institute for Bioprocessing Research and Training (NIBRT) Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland. Web: www.nibrt.ie Phone: +353 (0) 1 215 8100 Email: [email protected]


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Training Registration Form Name: Job title: Company / Institution (if applicable) Email: Phone number:

Address:

Date of request: Course Details Course title: Date: Number of attendees: Additional Information Would you like NIBRT to contact you to discuss a customised course? Please provide any additional relevant information.

Would you like additional information on NIBRT training, research or services?

Note: 1. Full payment must be received prior to the commencement of the course. Invoice and payment information will be sent upon receipt of Training Registration Form. 2. Please send this form to:NIBRT Training Director, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland. Email: [email protected]

FAX + 353 1 215 8116


Phone: + 353 1217 8107

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Training Catalogue 2017 - NIBRT - The National Institute

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