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 only provider of IRCA Approved ISO 13485 Internal Auditor Training in Ireland and one of three in the whole of Europe.
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.
We look forward to formally announcing our new Director in the coming weeks.
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, 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.
Dan Boland Lead Auditor and Trainer
Worked in Canada and Ireland for 7 years in management positions in the Healthcare and Food industries.
Dan worked for 15 years as Auditor General with Excellence Ireland, 6 years as Assessor/Senior Assessor with EFQM and 2 years as Editor of Self-Assessment Magazine.
Over 30 years experience in developing, implementing and auditing Quality Management Systems. Is a registered Lead Auditor and completed his MBA in 2000.
Associate lecturer in Trinity College Dublin for 10 years.
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.
David Kelly Consultant Trainer and Auditor
A multi-skilled, highly qualified consultant, trainer and auditor with experience in Quality Management Systems, Business Continuity Management, Environmental Management Systems, Occupational Health and Safety Management System, FMCG Manufacturing and Food and Drink Manufacturing. Experienced in HACCP implementation and international auditing and support.
David is a member of both the Institute of Environmental Management and Assessment and the International Register of Certified Auditors. He is currently completing an MSc in Environmental Sustainability in UCD.
David has completed assessments on behalf of multiple accredited certification bodies and has completed audits to ISO 9001 / 14001/18001 across a variety of industries.
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.
Martin Reddington Lead Tutor
Worked as Quality Manager in the Healthcare and Textile industries.
Over 20 years experience in developing and implementing Quality Management Systems and training.
Has trained hundreds of staff at all levels within organisations in Quality Management principles.
Developed and implemented a Quality Service initiative with AIB.
Registered Lead Auditor with IRCA.
Has extensive knowledge of Excellence Through People and has implemented ETP in many organisations.
Paula Kearney Consultant and Trainer
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).
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.