The Product Journey

The Product Journey
An insight into Design, Sterilisation, Testing,
Clinical Trial and Accreditation
This
one
day
conf
eren
ce w
ill
be h
eld o
n
16
Sept th
embe
r
“
“
The conference day will
include speakers from
DuPont, BSI and Boston
Scientific as well as Anecto
and Synergy Health’s own
in-house experts.
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
Who should attend?
R&D, Quality, Technical, Validation,
Regulatory, Microbiology, Engineering
Process Development, Planning
Procurement.
conference is to provide delegates with an
overview of all key elements of the product
Venue:
journey together with the opportunity to
Menlo Park Hotel, Galway
network with industry experts. The day
Date:
will start with presentations covering
16th September 2014
everything from the design process, ISO
Price:
11607 and sterilisation to packaging
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.
€95
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
“
Anecto is an
independent ISO
17025 accredited Test
Laboratory offering a
wide scope of testing
and consultancy
services
”
9.45am: Ursula Farrell (Synergy Health)
An Overview of Sterilisation
10.30am: COFFEE BREAK
10.45am: Noel Gibbons (Anecto)
ISO 11607 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
“
S ynergy Health is a
global outsourcing
provider to the
healthcare sector
and other related
markets
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
email them to the
following email
[email protected]
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
Email
Company Name
Address
TelephoneFax
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 1 •
Option 1 •
Option 1
Second choice:
Second workshop:
First choice:
Second choice:
•
Option 2 •
Option 2 •
Option 2 •
Option 2
•
Option 3 •
Option 3 •
Option 3 •
Option 3
•
Option 4 •
Option 4 •
Option 4 •
Option 4
How did you hear about the conference?
Email
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) 91 757 404
T: +353 5793 49999
E: [email protected]
w w w. a n e c t o . c o m
E: [email protected]
w w w. s y n e r g y h e a l t h p l c . c o m
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 11607 and
other test standards. He has also provided training on the requirements of ISO 11607 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 2006.
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 17025 requirements, with over forty methods accredited to ISO 17025
and numerous GLP toxicity studies and clinical trials successfully completed.
T: +353 (0) 91 757 404
T: +353 5793 49999
E: [email protected]
w w w. a n e c t o . c o m
E: [email protected]
w w w. s y n e r g y h e a l t h p l c . c o m