Irish Quality Centre (IQC) has been in business since 1997 and is one of Ireland’s leading providers of training, consultancy and auditing in Quality Management Systems, Environment, Health and Safety and Continuous Improvement across all industries.
We have a team of experts servicing all industries in relation to Management Systems. We have expertise in the HealthCare, Pharma, Biopharma and Medical Device industries.
Our internationally accredited IRCA and Exemplar Global approved Auditor Training courses include Internal Auditor, Lead Auditor along with auditor transition for ISO 9001, ISO 13485, ISO 45001, ISO 17025, ISO 14001 and Pharma/Biopharma.
For the Medical Device industry in addition to Auditor training we offer ISO 13485, Medical Device Regulations (MDR), Medical Device Single Audit Program (MDSAP) and ISO 14971 Medical Device Risk Management training.
Hundreds of personnel in organisations as diverse as AIB, Boston Scientific, Diageo, European Space Agency, Medtronic, Bord Gais, Medfill, Integer, Mylan and Pfizer are trained annually.
We take great care in selecting highly competent, technical people who have the necessary professionalism and interpersonal skills to be able to collaborate well with our clients.
We also assist organisations by integrating standards such as ISO 13485, ISO 9001, Good Manufacturing Practice (GMP), ISO 14001 and ISO 45001 with their business strategies.
DID YOU KNOW:
IQC is the first approved provider of IRCA MDR Training in Ireland.
Lead Auditor in Pharma, Biopharma and Medical Device industries.
Over 25 years' experience in auditing and management of Quality, Environmental, Health and Safety Management Systems.
Lecturer on Regulatory and GMP compliance. Worked in Pfizer Ireland Pharmaceuticals for 9 years supporting the drug substance manufacturing facility from green field site to full production, playing a key role in Training, Quality, Technical and overall GMP compliance.
Certified Human Factors Specialist (Human Factors and Error Prevention for Pharma, Biopharma and Medical Device companies).
Lecturer at Technological University Dublin and Griffith College (Regulatory Affairs and GMP, Technology Transfer, Validation and GMP Auditing).
Director of Technical Services
Senior Director/Advisor who will lead the MedTech side of the business including consultancy, auditing, and training.
Our new Director has many years' experiences in the medical device and other industry sectors in assessing conformance of established Quality Management Systems (QMS) against regulations and standards across various regulatory jurisdictions.
Including but not limited to conducting Stage 1 and Stage 2 assessment activities, supporting organizations to achieve successful certification.
Additionally, the experience and knowledge gained over the years both as an auditor and as an auditee supports a broad understanding of the auditing process and its complexities.
This experience gained is greatly beneficial in providing delegates who attend training both in the virtual and live environments with practical real-life situations that are encountered throughout the audit lifecycle when assessing conformance across various sectors of industry.
Proficient in the Management of Education and Training, Training Needs Analysis, Virtual and Blended Learning, Project Planning and Evaluation in Regulated Environments,. Experienced in Quality Management Systems, Lean and Six Sigma, Regulatory Affairs, PAT, CAPA, Root Cause Analysis, Quality Assurance, HACCP, Risk Management and Health and Safety.
IRCA certified in Lead and Internal Auditing ISO 9001:2015, Risk Management ISO 14971:2012 and Technical Writing. BA (Hons) in Education and Training Certified, Postgraduate Higher Diploma in Food Science and Technology.
Accomplished Information Technology Trainer with 32 years’ experience in administration roles within the legal, education, business and medical sectors.
Highly efficient in all aspects of communication, office management, customer service, multi-tasking and interpersonal skills.
JEB Teaching Diploma in Information Technology and ECDL.
A QA / RA expert with over 30 years’ experience in the regulated Pharmaceutical, Medical Device, In-Vitro Diagnostic industry, focused on Auditing, Quality Management, Compliance, Supply Chain Quality, Validation, Product development, Quality Management System establishment, and FDA / IVDR / MDR inspection readiness etc.
Self-employed QA / RA Consultant for 8 years, focused on medical device auditing, interim QA Management, medical device development, Quality system updates to meet new medical device regulations.
Completed a Masters in Environmental, Health and Safety Management and has expanded his focus to include Safety and Environmental Management system auditing as well as providing training to Quality and EHS auditors.
Lectures on Level 9 Medical Device Technology and Digital Quality Transformation MSc programs within Griffith College.
Consultant Lead Auditor and Trainer
Over 20 experience within the Medical Device Industry focusing on Regulatory Compliance and Quality Engineering for Combination Product and Active Medical Device Manufacturing at: Abbott, Cordis (JNJ) and Boston Scientific.
IRCA certified Lead Auditor covering Site, Divisional and Corporate Audits to the requirements of ISO 13485, MDSAP and EU MDR.
Lead auditor for geography specific audits including on-site audits within Brazil, Turkey, and India.
Supplier Lead Auditor of component and packaging suppliers to the Medical Device sector.
Experience in Medical Device manufacturer site start-up and establishment of the Quality Management System.
Expertise in manufacturing site preparation for Announced and Unannounced Audits including Front and Back Room Management, SME Training and Coaching, and GMP inspection programs.
Breda_Tanner-McKenna Consultant and Trainer
Strong technical background as one of the first women based in Ireland to successfully complete the Master Brewer studies.
Over 20+ years’ experience in a blue chip FMCG company to develop in Governance and Compliance while maintaining her operations competencies.
Breda is recognised as specialist in World Class Manufacturing, Global Governance and Risk Management Processes and Business Continuity Management, as well as having the breadth & experience to manage Governance and Compliance to Internal and International standards in the areas of Quality, Health & Safety, Environment and Technical Standards and Brewing Operations (Operations sites, partner / supplier site on behalf of Diageo).
Relationship building and networking skills are an integral part of her experience. Strong auditing experience internally in the Diageo global business (Beer and Spirits), and externally with suppliers and third-party operations across Europe, Africa, India, and The Americas.
Dr Prashanthi Kola Director, Lead Auditor and Trainer
Over 20 years’ experience as a multi-skilled highly qualified engineer in Quality Systems, High Volume Manufacturing, Failure Analysis, Research and Academia.
Areas of expertise are technical training development and delivery with particular emphasis on CAPA, Root Cause Analysis and Risk Management.
Specialising in the training of Internal Auditors, Lead Auditor and Risk Management (ISO 9001, ISO 13485, ISO 14971).
Educated to PhD level with 3 primary degrees in Maths, Mechanical and Manufacturing Engineering, Pharmaceutical and Medical Device Manufacturing.
Worked for Pfizer, HPRA, Maxtor and Hewlett-Packard.
Previously an associate Lecturer at Technological University Dublin.
Dr Ian Nelligan Consultant and Auditor
Over 30 year’s production experience in the pharma and biopharma industry. Has helped commission and start up blue chip biopharma plants in both Europe and the USA.
Has also been involved in due diligence and technology transfer projects in China, India, Pakistan and Mexico.
Led the design and start-up of the NIBRT biopharmaceutical training facility in the Republic of Ireland, which won the Innovative Design of the Decade award by Bioprocess Engineering Magazine in 2012.
The NIBRT training programme, set up jointly with IT Sligo, Ireland was awarded the Taoiseach’s Award for Public Service Excellence in 2012.
Expert in plant design, contamination control, troubleshooting, process optimisation, and the establishment of best practice on industrial manufacturing plants.