As of 30 June 2012, the 21821 Certificate IV in Quality Management and Assurance and the 21822 Diploma of Quality Management were discontinued by the National Training Authority and accreditation by Skills Victoria has not been extended after the 30 June 2012. These courses are now available under the National Qualifications Framework and you can gain the same outcomes by doing the Certificate IV in Frontline Management (Quality Focused Electives) or the Diploma of Quality Auditing (with Quality Management focused Electives). Quality is determined by the product users, clients or customers, not by society in general. This clause is essentially telling us that direction and overall performance overview of the Quality Management System must come from Top Management.  In some organisations Top Management may be the Board of Directors, the Managing Director,etc. Commitment from this level is essential to ensuring that the quality management system will be and is implemented to effectively support the business. The further clauses in section 5 of ISO 9001:2008 continue to address Management’s Responsibilities with regard to their Quality Management System.
One of the most important reasons for implementing a QMS is to ensure we fulfill the customer’s requirements so that they will continue to buy from our company. Well OK, there’s a whole range of issues that are problematic for McDonalds level of service – that would be a different learning unit. This story was shared with you to highlight the importance of understanding what the customer wants and then to determine how or whether indeed you can meet those needs.
The clause talks about Top Management and their requirement to ensure Customer Focus as this is essential to the strategy, objectives and plans for the business.
Simply speaking: this clause requires Top Management to establish and implement a Company Commitment to quality. The quality policy must be in some way documented and communicated to all employees so that all employees understand how the policy affects them.
In the real world of business this is often demonstrated as part of the business’ strategic and business plan.  Quite often the overview of such plans are summarised into a quality policy. The Quality Policy is essentially the tool that Top Management can use to communicate its purpose and strategy to all stakeholders (employees, customers, shareholders, community, etc).  It should not be vague, as it is also a tool for all key performance indicators within the business to measure against and monitor the business’ effectiveness of progress toward its strategic and business goals. There are three notes within this clause to provide clarity of quality management system documentation requirements, which are important to take into account when auditing a quality management system. When auditing a quality management system (or in particular performing a document review) this is usually the best place to start, as it provides auditors with an overview of the organisation and its management system to enable the decision of audit methods, tools, schedule and basis upon which you may find evidence of an effective quality management system. This clause further provides requirements for the effective control of documents within the organisation.
The intent of this clause is to ensure that documentation is being issued and changed via authorised means and that the validity of the documentation is clear so as to ensure that all personnel are following the correct an authorised versions of a documented procedure.
A documented procedure is intended to provide clear communication of a process or activity.
The intent of this clause is to ensure that an organisation decides upon the records they need to that provides evidence of conformity or non-conformity of processes and activities. The clause requires defined controls needed for identification, storage, protection, retrieval, retention times and disposition of records. To provide direction of an organisation’s quality management system they are required to establish, document and implement it. To ensure consistency and clarity of use of such procedures the organisation is required to control documented procedures and records. Get the Certificate IV in Frontline Management (Quality Focus) qualification with LMIT online.  Contact us today on 1800 222 140 to learn about our online training courses!
The new facility represents a major strategic investment in the bioprocessing industry in Ireland and is an innovative collaboration between four leading Higher Education Institutes – University College Dublin, Trinity College Dublin, Institute of Technology, Sligo and Dublin City University and supported by the Irish Government and IDA Ireland.
The NIBRT facility is unique as it is the only bioprocessing training facility in the world that so closely replicates an industrial bioprocessing environment. Ireland is a key location for the Life Sciences industry, with 9 of the top 10 global companies based here.
The 6,500 sq metres NIBRT facility is purpose-built to provide a world class training environment and was designed in conjunction with leading industry experts to resemble a modern bioprocessing plant. The staff in NIBRT includes expert lecturers and trainers and world respected research teams headed by leading Principal Investigators (PIs). The first meeting of Glycoscience Ireland was a great success with over 150 participants from academic research organisations, biopharmaceutical and food industries in Ireland and overseas and representatives of the major funding agencies in Ireland.
Over 120 delegates have arrived in Teagasc Food Research Centre, Moorepark, Fermoy to participate at the 4th Glycoscience Ireland meeting organised by Teagasc, AGRC, NIBRT and APC. The 4th GSI Meeting has attracted a number of key sponsors (AGRC, Teagasc, NIBRT, APC, SFI, EGSF, Eurofins Foods, Agilent, Mason Technology Ltd, Waters and Europa Bioproducts Ltd.) and exhibitors and has provided a unique platform for debate and discussion between academia and industry. Dr Tony Corfield, University of Bristol, UK and Dr Marguerite Clyne, UCD in their respective presentations outlined how bacteria in the gut use sugars to talk to the gut mucosal cells and mucus. The fact that there has been increased interest in recent years on glycobiology related research, means that the identification of novel diagnostic markers, prophylactics, therapeutics and nutraceuticals for gastro-intestinal health may become a reality.
Teagasc have had recent success in attaining funding for glycobiology related research and are partners in the NUIG-led Alimentary Glycoscience Research Cluster (AGRC) which is funded by Science Foundation Ireland.
The meeting is organised by Teagasc as part of the Alimentary Glycoscience Research Cluster (AGRC) in collaboration with NUIG, NIBRT and APC.
Dear Friends and Colleagues,We would like to invite you and your colleagues to join us for the 5th Annual Meeting of GlycoScience Ireland, which will be held at the Galway Bay Hotel, Salthill, Galway on Friday, 19th October 2012. GlycoScience Ireland is an academic organization that aims to support and promote Glycosciences research in Ireland and to provide visibility and collaborative opportunities for Irish glycoscientists with international academic and industrial communities.
Glycoscience Ireland has also provided a forum for communication and interaction between Irish glycoscientists and industry representatives in Ireland and further afield with the aim of assisting the translation of glycoscience discoveries into commercial realities.
The Annual GlycoScience Ireland meetings have been a great success, consistently attracting over 150 Irish and international participants from academic and research organisations, biopharmaceutical, diagnostics and food industries, and funding agency representatives. Lokesh Joshi, SFI Stokes Professor of Glycosciences,National University of Ireland, Galway. As the pipeline of Antibody Drug Conjugates (ADCs) therapeutics continues to show impressive growth*, NIBRT and IDA held an event to assess the opportunities and challenges for ADC manufacturing in Ireland and to identify the steps Irish based companies need to take to win ADC manufacturing projects.
This forum is to mark the presentation to Prof Pauline Rudd (NIBRT) with the prestigious Centre of Innovation Award from the Waters Corporation and the inauguration of NIBRT's Complete Process and Product Characterisation Facility. Agilent Technologies and The National Institute for Bioprocessing Research and Training (NIBRT) invite you to attend a joint seminar focused on analytical tools and solutions for the characterization and measurement of biologics throughout biopharmaceutical development and manufacturing. Agilent Technologies and The National Institute for Bioprocessing, Research and Training (NIBRT) invite you to attend a joint seminar focused on analytical tools and solutions for the characterization and measurement of biologics throughout biopharmaceutical development and manufacturing. Alexion has worked closely with the Department of Jobs and IDA Ireland on the development of its operations in Ireland.
Speaking at College Park, the Minister for Jobs, Enterprise and Innovation Richard Bruton TD said “Biopharma is a sector which we have specifically targeted as part of the Action Plan for Jobs, due to the large potential for employment growth which it offers Ireland, and we have taken a number of steps to support the growth of this sector in Ireland. Alexion currently employs a staff of 170 and growing across its facilities in Athlone and its temporary offices in Park West Dublin.
About Alexion Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialisation of life-transforming therapeutic products. Soliris is currently approved in nearly 50 countries for the treatment of PNH and in nearly 40 countries for the treatment of aHUS. The selected candidate will be expected to be competitive for the Science Foundation Ireland (SFI) Research Professorship Award.
The successful appointee will play a leading role in the research programme of the National Institute for Bioprocessing Research and Training (NIBRT).
The Professorship is complementary to other positions in the School, for example a recently appointed Lecturer in Chemical Engineering with a specific focus on Biophamaceutical manufacturing. The Irish biopharma industry continues to go from strength-to-strength with 18 biologics manufacturing sites and $9 billion in capital investment in the last decade.
For professionals, graduates, students and job seekers, this provides a unique opportunity to meet with blue chip biopharma companies. Registration is free for attendees but due to the high level of demand advanced registration is required. During the course you will retain your current social welfare payment and successful participants will be offered a paid work placement with BMS for 3 months. This programme is being run in cooperation with IDA Ireland, Skillnets, IMDA Skillnet, Department of Social Protection and Bristol-Myers Squibb.
Registration: The ATS Knowledge Day is a free event by invitation only but places are limited. Longevity and economic growth go hand in hand with innovation in the research-based pharmaceutical industry, according to Professor Frank Lichtenberg, of the Columbia Graduate School of Business, Columbia University, New York. Professor Lichtenberg was speaking at the 18th Annual Meeting of the Irish Pharmaceutical Healthcare Association (IPHA) at the Aviva Stadium which was titled Bringing the Best to Healthcare Through Partnership and Innovation.
One of a range of expert speakers from at home and abroad, Professor Lichtenberg told delegates that longevity increase is an important part of economic growth and development, which is in turn determined by  the rate of technological progress generated by private and public R+D investment.


Professor Lichtenberg demonstrated that despite the high costs involved in developing new medicines, investment in innovation by the pharmaceutical industry is greatly increasing life expectancy, and is greatly reducing disability and hospitalisation. Delegates also heard from heard Professor Ian Marison, Chief Executive of the National Institute for Bioprocessing, Research and Training, and Dr. Earlier in the day, the meeting looked at Government plans to introduce a universal health insurance system here along the lines of the Dutch model. Please note, you must register separately for the workshop and user meeting using the two links provided. The Biological Production Forum attracts senior industry biotechnology professionals working within biological manufacturing, bioprocess development, up and downstream operations. The Biological Production Forum is the must attend event for all those looking to incorporate new technologies and processes to increase efficiency whilst complying with tight industry regulations.
Guest speakers from Regeneron and ProSys will offer perspectives into procurement and service delivery, while IDA and EI will highlight opportunities in the sector, collaboration and future trends. Biopharma manufacturers who wish to get an overview of the innovative supplier network within Ireland and how this can help drive manufacturing competitiveness. Suppliers who wish to develop relationships with the fast growing biopharma industry in Ireland and with European buyers. Please contact us at any time to discuss your training requirements, or click here for further information on our training schedule. The French Trade Commission UBIFRANCE is the commercial section of the French Embassy in Ireland.
NIBRT have joined forced with Informa Life Sciences' to provide you an exclusive 25% discount to attend the upcoming BioProduction conference taking place on 14-15 October 2015 in Dublin, Ireland.
The Biotechnology Career Day will provide an opportunity to learn about BioMarin, prospective roles and meet the hiring managers and core team members.
Please indicate if you are interested in working for BioMarin but cannot attend on this day. There will be an opportunity to network with BMS hiring managers and you are encouraged to please bring copies of your CV.
Many thanks for registering for the BMS Careers Open Day in NIBRT on Saturday Nov 21st 2015.
Brinny, Cork, Sept 2nd, 2011: Global Healthcare leader MSD, in association with the National Institute for Bioprocessing Research and Training (NIBRT), has formed a partnership with Institute of Technology, Sligo to provide a ground breaking educational training programme for the workforce at their Brinny plant in West Cork. The Continuing Education Programme in Brinny is part of MSD's commitment to supporting science education and research in Ireland as it takes a central role in the country's future as a knowledge-based economy. John Howell, General Manager, MSD in Brinny said "Transformation is a key driver in securing the future of our business in Ireland and investing in the education of our employees is paramount to the success of this transformation process. The courses available include; a Higher Certificate in Science, a Bachelor of Science in Pharmaceutical Science, a Bachelor of Science in Biopharmaceutical Science and a Masters in Biopharmaceutical Science. Prof Ian Marison, Director of NIBRT expressed the importance of such training programmes for the Irish pharmaceutical industry and how NIBRT can bring together important partners from across Ireland, including this one with IT Sligo, to provide tailored, fully accredited training programmes to suit industry’s needs now and in a developing, very competitive industrial environment.
The Continuing Education Programme is fully funded by MSD in conjunction with the IDA, so there is no financial cost to employees. MSD employs 2,300 people directly in Ireland through its operations at sites in Carlow, Cork, Dublin, Tipperary and Wicklow. Institute of Technology, Sligo is the largest higher level education institution in the North West with more than 6,000 students and almost 600 staff.
The National Institute for Bioprocessing Research and Training (NIBRT) is a global centre of excellence for training and research in bioprocessing. NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. Customised NIBRT experiential training programmes for Bristol-Myers Squibb employees across all areas of the biopharma manufacturing process. Four-month training programme with NIBRT, followed by a paid three-month internship with Bristol-Myers Squibb for 20 skilled professionals through an association with Skillnet and the Department of Social Protection. The Cruiserath facility, which will employ up to 400 skilled science, professional and technical staff, will produce multiple therapies for the company’s growing biologics and diversified specialty medicines portfolio. QA includes regulation of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes. If we carry on giving the customers the goods or services we have, without finding out if they meet their needs, then eventually we lose the customers. In order for the business to succeed, it needs to understand the market demand and need, ensure there are systems in place to deliver according to what has been promised (contract) and having systems in place for continually monitoring the satisfaction of the customers in order to improve. The commitment needs to be specific, including goals and how the commitment to quality and the goals relates to the customers’ requirements. The International Standards Organisation (ISO) recognise that not every single process and parameter needs to be documented within an organisation when you consider that qualified personnel may be performing the tasks and so on.
There must be an implemented and maintained documented procedure as required by this procedure. This clause is simply saying ensure the communication tool (documented procedure) is controlled and current to reduce the risk of poor quality due to an incorrect procedure being followed. It is also intended to ensure that you maintain such records to prevent loss or damage of such records and no data from which to base organisational decisions upon. This allows trainees the opportunity to learn and practice complex technical bioprocessing procedures and to enhance their skills using the most modern equipment and facilities available anywhere.
Ireland will undoubtedly reap the benefits in the long run both in terms of high value job creation and in attracting further foreign direct investment from the industry to our shores”. We have now established Ireland as the second largest Development and Manufacturing (D&M) location in the world for Biopharmaceuticals, after the US.
The sector employs over 47,000 staff between indigenous and multinational companies in the areas of Pharmaceutical, Biotechnology, Medical Devices and Diagnostics.
An example is Professor Pauline Rudd, who recently transferred her team from the Glycobiology Institute, Oxford University, to NIBRT. This organization was established to encourage inter-disciplinary collaboration between Irish glycoscientists, biologists, chemists, engineers, information scientists and clinicians, interested in exploring novel glycoscience approaches to a variety of research questions.
Authors will be informed regarding the acceptance of abstracts by September 30th 2011 via email.
Bernd Stahl, PhD Director Milk Research and Functional Innovations, Danone Center for Specialised Nutrition, Friedrichsdorf, Germany focused on breast milk as the source of a huge variety of health-promoting sugars.
Such topics highlight that alimentary microbiology and glycosciences are each rapidly advancing research fields in their own right.
Since 2008, GlycoScience Ireland has successfully encouraged inter-disciplinary collaboration between Irish glycoscientists, biologists, chemists, engineers, information scientists and clinicians, interested in exploring novel glycoscience approaches to a variety of research questions. In this roadshow we will inform you about new developments and upcoming products in our benchtop fermentation range. During the session you will be able to get hands on experience with our exciting new products and technologies.
This FREE, 1-day seminar, will focus on enabling chromatography, mass spectrometry and automation technologies. This FREE, 1-day seminar, will focus on enabling chromatography, mass spectrometry, automation technologies and meeting the new USP regulations for elemental analysis.
Phase 1 of the College Park facility, comprising Global Supply Chain HQ, laboratories, packaging and warehousing operations is expected to be operational by year-end. This project further underscores our commitment to Ireland and is enabled by our ability to recruit highly competent and professional personnel to support the production and distribution of our medicine, Soliris, and our strong pipeline of biologics medicines. It underlines the jobs-led recovery that is underway, with 90,000 jobs created and the Live Register down by a third since the peak of the crisis.
Today’s announcement by Alexion is a huge boost for west Dublin and the whole country, and huge credit is owed to Julie and her team as well as the IDA. Alexion have rapidly grown their headcount and functional responsibility over the last year. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Under this programme, SFI will provide funding of up to €5 million in direct costs to support the research programme costs of the Professor and their research group. NIBRT's primary research focus is on the design, development and optimization of efficient and robust bioprocesses for the manufacture of therapeutic medicines. The UCD School of Chemical and Bioprocess Engineering has a long and distinguished international track record of achievement across major fields of research. The School intends to strategically grow its research programmes and educational offering in the area of Biopharmaceutical manufacturing in the next five years.
NIBRT is delighted to support this growth by holding our third annual Careers in Biopharma event on Saturday May 14th 2016 at the NIBRT facility.


While employers can meet and evaluate a pool of highly-skilled and motivated potential employees. This is not, he argues, increasing per capita medical expenditure with the benefits of such innovation exceeding its cost by a substantial margin. Graham Love, Director General of Science Foundation Ireland, on how innovation in the pharmaceutical industry in Ireland is being fostered and developed.
Kieran Ryan, Chief Executive of the Irish College of General Practitioners looked at the challenges the new system would bring to his members and argued in particular that it would require significant investment in primary care infrastructure. There will be a supplier exhibition, a delegation of European buyers, case studies from leading suppliers, opportunities for one-one meetings and tours of the NIBRT facility.
We’ll introduce you to our exciting new products and provide you with the latest information on bioprocess technologies and regulatory requirements.
To take advantage of this saving, please quote the following code: CQ3531NIBRT to claim your discount.
Additional car parking is available in main campus of UCD and travel via public transport is encouraged.
At MSD in Brinny we continue to be committed to developing talent and enabling our people to enhance their skills so that we are in a position to attract further investment to Ireland.
MSD hope to register up to 60 people for the programme this year with the aim of starting another rotation in 2012.
Our online courses provide such a degree of flexibility that it is possible for workers and students to take our courses from anywhere in the world. The company plans to role out similar education initiatives in conjunction with NIBRT to employees at several of the other 7 MSD sites in Ireland in the coming months. MSD is one of Ireland's leading exporters and contributes significantly towards making the pharmaceutical industry the country's leading export sector.
Its School of Science is the second largest in the Institute of Technology Sector, after Dublin Institute of Technology. NIBRT was primarily funded by the Government of Ireland through Ireland's inward investment promotion agency, IDA Ireland (Industrial Development Agency), which is responsible for the attraction and development of foreign investment in Ireland. The lab will house a team of 12 Bristol-Myers Squibb scientists who will advance complex bioprocesses used to produce BMS’s biologics products and benefit from close collaboration with the scientific staff at the NIBRT.
And you’ll know if it’s working for your business by regularly reviewing it’s effectiveness’. What this means is that direction of the Quality Management System comes from Top Management.
Our trainees will be the future leaders in an industry which plays such an important role in the Irish economy.
Glycoscience Ireland also provides a forum for communication and interaction between Irish glycoscientists and industry representatives in Ireland and further afield with the aim of assisting the translation of glycoscience discoveries into commercial realities. This year the meeting will be mainly focused on Food Glycobiology, and we are expecting our attendees to include representatives from the major Irish funding agencies, Irish academic institutions, Irish and multinational Food, Biopharmaceutical and Biotechnology industries, and a distinguished panel of speakers from the US and Europe.
He and many other researchers are attempting to better understand the sugar composition in breast milk, in order to use this knowledge to develop food ingredients for infants.
However, together these two disciplines can provide a better understanding of both symbiotic and pathogenic relationships between hosts and bacteria in the gut.
The 2012 meeting will focus on Next Generation Glycotechnologies and their relevance to BioPharma and the growing Natural Food sector in Ireland. The 2013 meeting will focus on Next Generation Glycomaterials, the role of glycotechnologies in BioPharma and Glycodiagnostics.
Approximately 560 construction workers are involved in the development of the current Athlone and College Park projects, and the planned expansion of College Park will also create over 800 construction jobs.
Alexion has a unique mission to develop life-transforming therapies for patients with severe and life-threatening ultra-rare disorders. Employment will be provided for 1000 extra people, and the knock-on impact of this massive €450 million investment for the wider economy will be enormous.
Alexion has begun recruitment for the College Park posts to build on its existing workforce and capabilities in Ireland.
In particular, it has world-class analytical and process development facilities up to pilot plant scale, along with the associated technical and support infrastructure.
Biochemical Engineering research has been a strength of the school for over 30 years and staff have published extensively in the leading journals in the field and participated in international networks and in a range of industry collaborations. The School is committed to the highest standards of undergraduate teaching, learning and student development in a research-informed environment.
The companies will have exhibition stands at this event and will also provide short presentations throughout the day. Michel Dutree, of Nefarma, which represents the pharmaceutical sector in the Netherlands, pointed to what he saw as real shortcomings in the system there which he claimed is completely cost driven, with only lip service to quality. The rig simulates (bio)pharma production and cleaning processes and the course covers all elements of instrumentation including measurement, digital communication, process control and Life Cycle management (LCM).
The support of Government to industry in these initiatives is key to the future success of the life sciences sector in Ireland".
This flexibility is crucial in the workplace at the moment, because it provides companies and employees with the opportunity to update their skills without leaving the workplace, allowing them to maintain their competitiveness. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions.
MSD is a member of Guaranteed Irish and manufactures or packages many of its leading products for the world market in Ireland.
IT Sligo is a recognised national leader in online education and has worked closely on staff training with a wide range of leading multinational companies such Coca Cola, Masonite International, Abbott Ireland and Baxter.
This facility is purpose built to closely replicate a modern bioprocessing plant with state of the art equipment. NIBRT offers a quality training and research experience not previously possible anywhere in the world.
Our ability to successfully integrate ground-breaking research with world class training and education makes NIBRT globally unique”. Our aim is also to work with industry to identify the key issues affecting the biopharma industry today and to put together expert teams of scientists to solve these problems”. Pauline Rudd NIBRT both strongly support food glycobiology related research in Teagasc and chaired sessions on the day. Our mission is to support and educate industry in the application of technical knowledge and modern methods to achieve excellence in product and process design, manufacturing, scale-up, technology transfer and control. An additional key element of its research programme is to support the Irish biopharmaceutical industry. Pat O’Mahony, Chief Executive of the Irish Medicines Board outline how regulatory structures can work to encourage innovation. UBIFRANCE offers a comprehensive range of products and services including pavilions and B2B meetings, aiming at accompanying French-based companies in their development on export markets and help them to meet their international counterparts.
Our close links with NIBRT enable us to jointly offer a programme of a high academic standard, while being very focused towards the industry’s educational requirements". NIBRT fully supports this initiative and will work closely with MSD to achieve a high calibre programme which will benefit the company and enhance Ireland’s reputation as being at the forefront of the (bio)pharmaceutical industry" said Prof Marison.
We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. Paul Ross, also gave insight into how beneficial bacteria such as probiotics, can also produce sugars which allow them to survive better in the gastrointestinal tract. Steve Thomas of Trinity College, Dublin, acknowledging that the planned reform was a real opportunity, argued that this was dependent on the Government following the right and appropriate model for Ireland. A team of students from IT Sligo took first place in the global final of the Microsoft Imagine Cup, the world's leading student technology competition, earlier this summer. David Newburg, Boston College, Chestnut Hill, US, also discussed the health benefits of human milk sugars and their principal components.
Through my Department and the IDA, I look forward to building on our strong relationship with Alexion and wish them every success with this project”. Characterization of powder flow properties and their effects on process and product performance.



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