Medical Devices Committee Biographies
Alan manages an independent quality management consultancy, Clinical Compliance Services. Previously he was the Quality Assurance and Regulatory Affairs Manager for Wesley Coe, a sub-contract manufacturer to the medical device industry. He has several years experience in the pharmaceutical and medical device businesses in R&D, project management, quality and regulatory roles. His quality management experience covers GLP, GCP, cGLP, GMP, as well as the application of International Standards in both public and private sector organisations.
Since graduating from Kings College, London with a science degree, Nayem's career to date has seen her take on a number of roles within the pharmaceutical and medical devices industry. The roles have included QMS, operational quality and compliance responsibilities.
In 2011, Nayem joined the medical devices team at the British Standards Institute (BSI) as one of their six full time assessors in the UK. This role saw her undertaking assessments on behalf of the Notified Body, ranging from Class 1 to Class 111 passive medical device manufacturers.
Nayem has since moved back into industry and is currently the QMS Manager for Norgine Limited, where she has been since January 2014. Her current role includes the management of Norgine's Quality Management System, in line with both pharmaceutical GxP and medical device requirements and the implementation of a global electronic QMS system.
Neil is a freelance consultant with over 30 years experience of the medical device industry. He has held both technical and operations directorships with Zimmer in the UK and has been responsible for developing and getting to market a wide range of medical device technologies. He is a Chartered Engineer with a BSc in Materials Science from the University of Bath and a MBA from the Open University.
Yvanne is founder and Managing Director of PHARMExcel Ltd. She studied for her BSc (hons) degree in critical care at the University of Hertfordshire whilst working as a nurse at the Royal Free Hospital, London. She has over 17 years trials experience both in the academic and private sector. She started her career managing a commercial Clinical Trials Centre involved conducting Phase 11-1V clinical trials, later joining Freemedic Clinical Research and the Development Unit for University College London (UCL), taking over as Assistant Director for Clinical Trials with a primary focus of establishing their Sponsor systems. In 2008 she moved to the private sector working for a small CRO as their Quality Assurance Managing working with global systems across EU, Asia Pacific and the USA. She has led a number of successful Medicines and Healthcare products Regulatory Agency (MHRA UK) and FDA audits to date.
Following this she launched PHARMExcel Ltd and is involved in the key operational aspects of the company, most recently supporting small, emerging US companies in the progression of their medical; device trials within the UK.
Yvanne has extensive knowledge of the European and UK clinical trials and device regulations. She is a member of the Institute of Clinical Research (ICR), the Research Quality Association (RQA), The Organisation for Professionals in Regulatory Affairs (TOPRA) and sits on the sub-committee for the ICR Freelancers. She was recently involved in assisting the RQA Medical Device Committee in the rewriting of the Medical Devices Regulation Booklet.
Upon completion of his education in analytical chemistry, Henny started his employment in the pharmaceutical research and development department of Organon in 1975. Within R&D his expertise and focus were on analytical method development and pharmaceutical formulation technology. In 1977 he joined Organon's sister OTC company Chefaro International as formulation specialist in colloid chemistry and later became development laboratory manager. In 1993 he moved to international manufacturing and additionally holding the position of manager processing of the production department in Rotterdam.August 200 he rejoined Organon to apply his broad pharmaceutical experience in compliance control and Quality Systems. In 2006 he moved to Global Quality as Compliance Manager in the set up of a business wide Quality Management System for Oganon BioSciences where he was assigned manufacturing (GMP), ISO (Medical Devices) and Management related systems. After the take over by Schering Plough he became Program Manager for Global Clinical Quality Systems. When Schering Plough merged with MSD/Merck, he decided after 36 years of employment in the pharmaceutical arena, to start his own business and founded Qimp Management Systems Ltd. Henny hold a Master in Quality Management.
Colette McIntyre (Chair)
Colette graduated from the University of Newcastle Upon Tyne with a B.S.c (Hons) in microelectronics and Microprocessor Applications. Since graduating Colette has held a number of Quality Assurance roles in the medical device, telecommunications and automotive industries and has aquired over 20 years of experience in quality management and auditing. Colette's current role is GLP/GCP Specialist with HeartSine Technologies where her responsibilities include ensuring regulatory compliance for non-clinical and clinical studies and risk management activities during product development.
Jonathan is Quality Manager at Primerdesign, a company focused on the design, manufacture, validation and supply of real-time PCR kits and reagents. The company maintains ISO 13485:2012 certification and also carries out contract manufacture for CE marked kits under this quality system.
Previously to this Jonathan's experience was within the GxPs, primarily working under GMP and GCP at the Defence, Science and Technology Laboratory (Dstl) at Poerton Down providing expertise to the GMP and GCP trial programmes and managing Quality Systems. Towards the end of his career at Dstl Jonathan managed the ISO 9001:2008 compliant corporate audit programme across 4 sites and 20 departments. Jonathan has also worked in the pharmaceutical industry for Emergent Biosolutions and Celgene providing drug development quality assurance,
A particular interest of Johnathan's is how people impact a company and the quality of its products.
Fraser is currentlyExecutive Director of Quality and Compliance at PPD where he is responsible for the direction and leadership of Phase I-IV global clinical quality assurance activities. Prior to joining PPD in 2009 his previous roles have included Head of Quality & Compliance at Systagenix Wound Management, plant Quality Assurance Manager roles at Johnson & Johnson Wound Management and Johnson & Johnson Medical as well as Quality Systems Manager at Ethicon.
Teresa Zubel has over 15 years’ experience within the pharmaceutical industry and clinical research, mainly in quality and compliance focused roles. Her expertise includes clinical trial monitoring, training, management of out- sourced activities, coordination and coverage of audit programs, CAPA, inspection support, providing advice on quality and compliance issues. Her audit experience includes performing audits in Pharmacovigilance and GCP space. Medical device area is recent addition to Teresa’s professional portfolio. In her current role, as Labelling Manager at Centre of Excellence in Ethicon, Cardiovascular and Speciality Solutions, Teresa is mainly responsible for change control activities and execution of labelling projects.