Validation must top the agenda for medical product developers

Industry experts explain how focus on validation at the outset of medical product development will avoid delays in getting products to market †

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.

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 forthcoming Midlands microbiology conference. The conference is being held on 5 March at the National Motorcycle Museum, Birmingham, UK.

The conference will involve specialists from Synergy Health, Pall Life Sciences, Associates of Cape Cod (ACC), Meddiquest and Anecto, who will outline all elements of the validation process, including sterilisation technologies, ISO standards, packaging, accelerated aging, validation microbiology and endotoxin testing.

Jenni Tranter from the Applied Sterilisation Technologies (AST) division of Synergy Health, says: 'Functionality and saleability understandably, are primary concerns of businesses developing medical or pharmaceutical products. But, in an increasingly complex regulatory environment, itís 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 donít 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,' she added.

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 companyís 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.

Morning Presentations

Mark Botting - Synergy Health: Sterilisation technologies overview

Wayne Barnes - Synergy Health: ISO standards overview

Noel Gibbons Ė 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 donít 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

To register or to find out more email education@synergyhealthplc.com or visit www.synergyhealthplc.com/en/events/laboratory-conference-5th-march-2014. Registrants can also phone 08456 88 99 70.

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