Validation Tops Agenda for Medical Product Developers at Conference
Focusing on validation at the outset of medical product development will help avoid delays and frustration in trying to get these products to market, experts warn. The importance of factoring in validation requirements at the start of the development process will be one of the key themes on which delegates from the medical devices and pharmaceutical sectors will be briefed at a Midlands microbiology conference, 5 March 2014.
Delegates will hear how the emergence of increasingly complex medical devices has resulted in regulation and validation requirements becoming more demanding than ever, making it essential for businesses to be fully aware of up-to-date standards before embarking on new development projects.
Jenni Tranter, from the Applied Sterilisation Technologies (AST) division of Synergy Health, said: “Functionality and saleability are understandably primary concerns of businesses developing medical or pharmaceutical products.
“But, in an increasingly complex regulatory environment, it’s more important than ever that validation processes are understood and considered from an early stage. This is particularly relevant for smaller companies developing cutting-edge health technology that don’t have their own in-house sterilisation validation experts or testing facilities. This event will help increase their awareness of the challenges they face and how to address them in a practical way.
"Crucially, the day will also focus on specific challenges in action, offering case studies of success stories and instances where problems in device development have had to be overcome."
During the conference, specialists from Synergy Health, Pall Life Sciences, Associates of Cape Cod (ACC), Meddiquest and Anecto will outline all elements of the validation process, including sterilisation technologies, ISO standards, packaging, accelerated aging, validation microbiology and endotoxin testing.
Conference workshops will also demonstrate how to overcome challenges in areas such as, devising a sampling plan for endotoxin testing, validating product families, developing a medical device and embarking on packaging and age-testing activities.
In addition, representatives from Synergy Health will share the company’s technical expertise and experience in all aspects of microbiological validation, including their involvement in the development of international standards for the sterilisation of healthcare products; the ISO11137.
The conference will provide a platform from which healthcare professionals, businesses and academics can learn from each other and exchange best practice, providing crucial growth and innovation opportunities for the health technology sector. The event will be of relevance to individuals and organisations at all stages in health technology development, including those already selling into the market and well as those just exploring it.
To register or to find out more, email education@synergyhealthplc.com or visit http://www.synergyhealthplc.com/en/events/laboratory-conference-5th-march-2014 Registrants can also phone: +44 8456 88 99 70. The event will take place at the National Motorcycle Museum, Birmingham.
Morning Presentations
Mark Botting — Synergy Health
Sterilisation technologies overview
Wayne Barnes — Synergy Health
ISO standards overview
Noel Gibbons — Anecto
Packaging & accelerated age testing — best practice approach
Associates of Cape Cod
Endotoxin — best practice approach
Carole Durant — Pall Life Sciences
Customer perspective
Afternoon Workshops
Overcoming challenges (Pre-registration required)
Option 1: Associates of Cape Cod
Endotoxin testing - how to pool devices for testing
Option 2: Su-Finlay Woods & Charlotte Byrne — Synergy Health
Complex products & product families — how to validate
Option 3: Neil Armstrong — MeddiQuest
Development of Medical Devices — what happens when things don’t go according to plan?
Option 4: Noel Gibbons — Anecto
Packaging and Ageing testing — what exactly is required?
Panel discussion: all speakers/workshop leaders
Conference Chair: Jenni Tranter — Synergy Health