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 particular expertise in the HealthCare, Pharma, Biopharma and Medical Device industries.
Our internationally IRCA-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 work 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 experience in the medical device industry both in a Regulatory and Engineering capacity and has a unique understanding of all regulatory aspects associated with the life cycle of a medical device, all categories and classifications.
Having recently completed a Masters in Medical Device Regulations there are few in Europe with this level of understanding of the complexities of all Medical Device Regulations.
IQC Training Specialist
Training Executive with a broad range of training and education experience within the Further, Higher and Private Sectors since 2004.
Proficient in the Management of Education and Training, Training Needs Analysis, Virtual and Blended Learning, Project Planning and Evaluation in Regulated Environments. Knowledge of 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.
Trainer and Consultant
Over 25 yrs of experience in all aspects of Quality Systems in GMP regulated Medical Device Pharmaceutical and Biopharmaceutical companies.
15 years experience of auditing Pharmaceutical Quality Management Systems.
Experienced Aseptic and Sterile manufacturing consultant.
Lead SME for GMP Training in MSD, responsible for overall site GMP compliance.
EFQM assessor for 7 years with Organon Ireland Limited, Dublin.
Facilitator for Human Error Reduction programmes in GMP regulated environments.
Lecturer at Technological University Dublin and Griffith College Dublin (Technology Transfer, Pharmaceutical Manufacturing & Distribution, Production Management & Supervision).
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.
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 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.
Paul Rooney Consultant and Trainer
Over 20 years production experience in Medical Device Industries and Electronics, developing and implementing Quality Management Systems and associated training.
Quality Management Systems Consultant.
Project Manager for major global IT solutions for multiple sites.
Lecturer at Institute of Technology Tallaght in Medical Devices Manufacturing, GMP compliance and LEAN.
Dr. Suzanne O’Rourke Consultant Lead Auditor and Trainer
Quality, Regulatory and Engineering specialist with 25 years multi-functional experience in the Medical Device sector, with proven experience in the development, initial certification and recertification of quality management systems, design and development controls, design and quality, sterilization through to regulatory approvals (FDA, EU) and product launch readiness.
Includes management of transition including those arising from remediation (corrective and preventive actions), progressive transition including changing international standards, product change management and re-approval.
Expertise in remediation activity including addressing complex product performance problems, field corrective action and quality system challenges.
Areas of expertise span start-ups to multinationals, including niche experience with active and active implantable devices, Suzanne has worked with Mainstay Medical, Stryker, Guidant and Boston Scientific.
Suzanne is an active member of Engineers Ireland Biomedical Engineering Division and holds a MSc in Medical Technology Regulatory Affairs (Cranfield) and a PhD in Biomedical Engineering. A qualified ISO 9001, ISO 13485 lead auditor with experience completing assessments for companies managing systems across the diversity of medical device classifications.
Mehul Patel MSc, MRSC, CSci, B.Pharm [Qualified Person] Certified QP Auditor, Consultant and Technical Expert.
Over 16 years experience in Pharma/Biopharma industry research and manufacturing. Qualified Person since 2014.
Areas of expertise: Regulatory Dossier review [MAA], Quality By Design (QBD), Sterile Manufacturing, Cell and Gene Therapy, API Auditing and Contract QP.
Educational Qualifications includes QP Certification, MSc Pharmaceutical science, BSc Pharmacy and Phamra Lead Auditor.
Dr Munira Derby Medical Adviser, Consultant, Lecturer MD, MSc, Gastroenterology and Hepartology BA (Hons) in Pharmaceutical Business Operations
• Expertise in all aspects of Preclinical and Clinical Trial development in all stages;
• Experienced in Therapy Areas; Human Physiology; Pathology; Immunology.
• Practiced over 20 years as Medical Doctor in hospitals worldwide, highly experienced in drug safety monitoring, Adverse Events and Regulatory Requirements in Drug Development Process; (FDA, EMA)
• Proficient in Clinical Trail Development in all phases as well as Regulatory Compliances in Pharmaceutical Industry.
• Completed - BA (Hons) in Pharmaceutical Business Operation (Griffith College, Dublin)
• Upskilled on – New Regulatory Compliances in Pharmacovigilance – Principles of risk - benefit analysis - (Drug Safety Research Unit - DSRU Southampton, UK).
• Fluent in languages: English, Turkish, Russian and Farsi.
Andy Brophy Lean & Innovation Improvement Advisor.
Andy Brophy is a Lean & Innovation Improvement Advisor. He has been working in the Lean field for the last 20 years with a diverse range of organizations’ including manufacturing, construction, government, services, online, software development, and hospitals.
Andy is a professional engineer (BEng in Manufacturing) and holds a 1st Class MSc in Lean Operations from Cardiff University and is Six Sigma Black Belt certified. In May 2010 he published the co-authored book Innovative Lean with John Bicheno of the Lean Enterprise Research Center in the UK. This work is primarily based on the power of harvesting and implementing employee ideas and creating an innovative and empowered workforce.
In 2011 he was selected by Pearson’s the world’s largest book publisher to write The Financial Times Guide to Lean. The book is translated into Spanish, German, Dutch, Indian and Japanese.
White, Yellow, Green, and Black Belt Lean Sigma instructor (> 6000 delegates certified).