The Product Journey. An insight into Design, Sterilisation, Testing, Clinical Trial and Accreditation

Transcription

1 The Product Journey An insight into Design, Sterilisation, Testing, Clinical Trial and Accreditation This one day conference will be held on 16th September The conference day will include speakers from DuPont, BSI and Boston Scientific as well as Anecto and Synergy Health s own in-house experts.

2 The Product Journey In a joint venture on the product journey, Anecto and Synergy Health present a one day conference, giving delegates the opportunity to engage with industry experts on a range of subjects. Guest speakers come from companies and regulatory bodies including DuPont, BSI and Boston Scientific as well as experts from within Synergy Health and Anecto. Brief synopsis Understanding the product journey is vital to help prevent in-warranty product returns, reduce costs and ensure product compliance. The aim of this one day conference is to provide delegates with an overview of all key elements of the product journey together with the opportunity to network with industry experts. The day will start with presentations covering everything from the design process, ISO and sterilisation to packaging Who should attend? R&D, Quality, Technical, Validation, Regulatory, Microbiology, Engineering Process Development, Planning Procurement. Venue: Menlo Park Hotel, Galway Date: 16th September 2014 Price: 95 material and regulatory compliance. The afternoon sessions will feature workshops giving delegates the opportunity to focus on specific topics of interest and overcome some of the challenges faced.

3 Training Day Agenda 8.15am: COFFEE & REGISTRATION 8.50am: Michael Connolly (Anecto) Opening Address Presentations 9.00am: Donal Devery (Vysera Biomedical) Production Realisation: Developing a new product 9.45am: Ursula Farrell (Synergy Health) An Overview of Sterilisation Anecto is an independent ISO accredited Test Laboratory offering a wide scope of testing and consultancy services 10.30am: COFFEE BREAK 10.45am: Noel Gibbons (Anecto) ISO Testing Requirements 11.30am: Magnus Graham (BSI) Regulations 12.00pm: Ailbhe Casserly (Boston Scientific) Beyond Commercialisation The Product Journey Continued 12.30pm: Eric Schmohl (DuPont) How to Prepare for The Tyvek Transition: Technical & Regulatory Information to Support a Smooth Move 1.00pm: LUNCH Afternoon Workshops 2.00pm: First Workshop (Pre-registration required) Option 1 - Noel Gibbons (Anecto) Design Flaws and Steps Towards Success Option 2 - Lorraine Moran & Richard Cowman (Synergy Health) The Validation of Sterilisation Option 3 - Fionnuala Gibbons (MMI) Clinical Investigation in New Product Developments Option 4 - Charlotte Byrne & Sarah Conway (Synergy Health) Complex Products and Product Families: How to Validate 3.00pm: Coffee break 3.30pm: Second Workshop 4.30pm: Wrap-up 4.45pm: Close Synergy Health is a global outsourcing provider to the healthcare sector and other related markets

4 booking form The conference will take place on the 16th September 2014, at the Menlo Park Hotel Galway. To confirm your attendance please complete the form below. The fee for this event is 95 (ex. VAT) To book your place simply fill in the attached forms and them to the following If you have an account with either Anecto or Synergy Health please provide a purchase order number. ONCE BOOKINGS ARE CONFIRMED, PAYMENTS CAN BE MADE THROUGH PAYPAL VIA THE ANECTO WEBSITE. ALL PAYMENTS MUST BE COMPLETED PRIOR TO COMMENCEMENT OF THE SHOW. PLACES ARE LIMITED SO FAILURE TO PAY IN TIME MAY RESULT IN YOUR BOOKING BEING GIVEN TO ANOTHER. Name Position Telephone

5 Company Name Address Telephone Fax Invoicing Address (If different to main Company Address) Purchase Order Number Pre-registration required for the two afternoon workshops. Please indicate your first and second choices below: First workshop: First choice: Option 1 Option 2 Option 3 Option 4 Second choice: Option 1 Option 2 Option 3 Option 4 Second workshop: First choice: Option 1 Option 2 Option 3 Option 4 Second choice: Option 1 Option 2 Option 3 Option 4 How did you hear about the conference? Website Regional Sales Manager Other We will confirm your booking within 7 working days of receipt. If you are unable to attend but would like further information on Anecto or Synergy Health services, please tick here Cancellations & force majeure; registrants cancelling up to 28 days before the event will receive a full refund. However, after this time, registrants will be liable for the full fee. In the event of circumstances beyond our control, we reserve the right to alter the programme, speakers, date or venue. T: +353 (0) E: Sales@anecto.com T: E: Ireland@synergyhealthplc.com

6 Biography of speakers and presenters Donal Devery is a founder of Vysera Biomedical and serves as Chief Executive Officer. Vysera have developed medical devices for gastrointestinal and urology applications. Donal has over 25 years experience in product development and technology commercialization in a variety of disciplines from small start-up companies to large multinationals. Prior to Vysera Donal was Director of Engineering at Aerogen Inc. where he successfully led the product development and commercialisation of new medical device and drug delivery products. Ursula Farrell has worked in Synergy Health for 12 years as the Ireland Sales and Marketing Manager. She is responsible for all the sterilisation technologies in Ireland EO, Ebeam and Gamma Irradiation and also the associated laboratory services. Noel Gibbons is the Lead Programme Manager at Anecto. He has significant experience in a wide variety of areas including package testing, package integrity testing, quality and international test standards. He has presented seminars internationally on medical device & pharmaceutical testing including the requirements of ISO and other test standards. He has also provided training on the requirements of ISO to companies throughout Europe and is a member of a number of ASTM and NSAI packaging committees. Magnus Graham has 9 years experience with BSI (Certification Body and Notified Body) working within the UK and the European medical device manufacturers, chemical plants, healthcare providers and general manufacturers. He specialises in Sterilisation and Microbiology Audits, Sterilisation Assessments of Design Dossiers, Certification Decisions and Training Delivery. Eric Schmohl is responsible for Tyvek Customer and Application Support at DuPont Medical & Pharmaceutical Protection in Europe. He is a qualified Textile Technology Engineer and has more than 20 years experience in Technical Support for various fibres and non-woven businesses. He has worked with Tyvek since Lorraine Moran is Ireland Regional Manager for Synergy Health. She joined eighteen years ago as Quality Manager, became Plant Manager at the Westport facility in 2000 and took up her current role last year. She has vast experience in provision of Irradiation, both Gamma and Electron Beam, to the Medical Device industry. Richard Cowman is Synergy Health s EO Technical Manager for UK & Ireland. Having held a number of operational, quality and technical roles with Synergy Health and an Irish based multinational medical device manufacturer over the last 20 years, he has a comprehensive knowledge of the EO sterilization requirements for the medical device industry. Fionnuala Gibbons is Clinical Industry Liaison Officer for Molecular Medicine Ireland (MMI), a role sponsored by Enterprise Ireland, with responsibility for the development of clinical research process knowledge and awareness among the researchers, indigenous and multi-national medical devices, diagnostic, pharmaceutical and biotechnology companies. Fionnuala has a wealth of experience and knowledge across the medical device & pharmaceutical industries and provides support in the development of the government initiative Health Innovation Hub. Ailbhe Casserly works as a Senior Research & Development Engineer for Boston Scientific Corporation. Her experience includes over thirteen years of analytical, mechanical and project management expertise in research, development and commercialisation of interventional cardiology medical devices, specialising in drug-eluting stents. Ailbhe also worked as an Analytical Chemist with pharmaceutical company Allergan for two years prior to joining Boston Scientific. Charlotte Byrne is the Laboratory Business Manager for Synergy Health s AST microbiology laboratories. Charlotte has gained an in-depth knowledge of laboratory method development and validation for an extensive range of products/ devices to be compliant with GXP, FDA or ISO requirements, with over forty methods accredited to ISO and numerous GLP toxicity studies and clinical trials successfully completed. T: +353 (0) E: Sales@anecto.com T: E: Ireland@synergyhealthplc.com