synergy health ast emea training programme 2015
TRANSCRIPT
Training Programme 2015
CONTENTS
Webinars 3
Workshops 5
Conferences 8
Annual Conference 9
Tailored Training 10
WWW.SYNERGYHEALTHPLC.COM/STERILISATION
FOR MORE INFORMATION CONTACT US:
EMAIL: [email protected]
PAGE
Welcome to the Synergy Health Applied Sterilisation Technologies (AST) Training Brochure
The AST training programme offers a variety of opportunities
to organisations wishing to increase their knowledge
base associated with sterilisation. We offer a wide range
of educational events throughout the year including
all core technologies and microbiological validations.
Training events can also be tailored to meet your specific
requirements and delivered on-site at your facility.
FOR ALL OUR LATEST NEWS AND
EVENT INFORMATION FOLLOW US:
@synergy_health
Synergy Health PLC
/synergyhealthplc
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, Synergy Health reserve the right to alter the
programme, speakers, date or venue.
COGENT GOLD STANDARDS PROGRAMMESynergy Health (AST) is pleased to announce
that it has completed the assurance process for
the Cogent Gold Standards Programme.
Working with Cogent and SIP (Science Industry
Partnership) we are now able to offer Cogent
accredited courses for the UK based workshops, giving
attendees access to the SIP funding available for
SME’s in the UK.
The SIP is focussed on improving the skills of science
based company employees ensuring the UK scientific
sector is globally competitive. The industry has
highlighted a number of areas where help is required
and our workforce development initiatives are the
result. These are underpinned by the Cogent Gold
Standard Programme.
The Cogent Gold Standard is a kite mark which gives
recognition for excellence in skills in the science
industries. All workforce development initiatives
are aligned to the Gold Standard framework to help
companies to become Gold Standard companies - those
with skills and training at the heart of their business
development plans.
Solutions for SME’s individuals within the SME
workforce, through their skills and contribution, are
delivering the innovation that is so fundamental to
this strategic sector. Cogent Skills, has worked with
industry to identify the key skills that small companies
recognise as critical for sustainable business growth.
“Synergy Health provide independent training courses in the UK, Ireland and mainland Europe ”
WEBINARS
We are uniquely positioned to provide expert insight into a range of topics relating to our technologies ”
“
CONTACT US TO REGISTER YOUR INTEREST:
EMAIL: [email protected]
WWW.SYNERGYHEALTHPLC.COM/STERILISATION
BRIEF SYNOPSIS
These sessions will provide an insight
into finding solutions to the everyday
challenges associated with the
sterilisation of devices.
WHY JOIN OUR WEBINARS?
• Focused learning opportunities
• User friendly for participants
• ‘Green’ communication tool - no travel/accommodation costs
• Engaging and interactive audience experiences
WEBINARS UNDERSTANDING ISO DOSE ESTABLISHMENT AND ROUTINE MONITORING: (ISO 11137/ ISO TS 13004)
• Sterilisation validation methods
• Product families
• Dealing with complex product
• Routine monitoring
ISO 11135:2014 UNDERSTANDING THE CHANGES AND ENSURING A BALANCED APPROACH:• History of ISO 11135
• Overview of changes
• Implications of changes
• Importance of a balanced approach
• Moving forward - compliance by 2017
TECHNOLOGY COMPARISON & BENEFITS:• Technology overview
• Key differences
• Advantages & disadvantages
• Choosing the correct technology
• Concept to market
X-RAY PROCESSING• Introduction to x-ray processing
• Processing capabilities
• Comparison with other processing technologies
• Practical aspects and considerations
• Benefits of x-ray
Our events provide the core knowledge required in industry today on all modern sterilisation techniques ”
“
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For the latest webinar dates please visit our website.
These one hour webinars are FREE to attend and are designed to give
participants an overview on key topics pertinent
to the healthcare and life sciences industries.
www.synergyhealthplc.com/en/events
WORKSHOPSBRIEF SYNOPSISWith over 30 years’ experience, Synergy Health PLC is the partner of choice for providing sterilisation solutions, validations and support services to our network of customers. Through a network of 42 sites in 16 countries across Europe, Middle East, Asia & Africa and the Americas. Synergy Health PLC operates the 4 principle sterilisation technologies of Gamma, Electron Beam, Ethylene Oxide and X-ray.
With this extensive knowledge of industry standards and a wealth of experience, Synergy Health is able to provide customers with unrivalled training and consultancy service.
The workshops are highly successful and rewarding examples of our ongoing commitment to exceeding the needs of our customers.
WHY ATTEND OUR WORKSHOPS?
• Tailored and focused learning
• Expertly led workshops
• Small group numbers for optimal development
• Value for money
• Participant led itinerary
• Group discount available
WORKSHOPS AVAILABLE:
• Radiation sterilisation of medical devices
• Ethylene Oxide processing
• ISO validation and microbiological compliance
WWW.SYNERGYHEALTHPLC.COM/STERILISATION
CONTACT US TO BOOK YOUR PLACE:
EMAIL: [email protected]
RADIATION STERILISATION OF MEDICAL DEVICES
BRIEF SYNOPSIS
The need to understand and compare the available
technologies and take into account the regulatory
requirements is essential for any manufacturer of sterile
devices. The relationship between manufacturers and
sterilisation providers is an important element in assisting
with the production and supply of products to customers.
This sterilisation course will provide a valuable overview
of the available technologies as well as guidance on
understanding the factors needed to take into account
when considering sterilisation. It will also examine
approaches for validating these processes to ISO
Standards. Our courses are designed to give practical
guidance to the participants and to explore new cycle
design and regulatory requirements.DATE: 16TH SEPTEMBER NOVEMBER (TBC)
COURSE OUTLINE:
• Introduction to radiation
• Background on Gamma, E-Beam and X-ray
• Dose mapping validations
• Routine processing
• Effects of radiation on materials
• Facility tour
• Practical aspects of radiation processing
ISO VALIDATION AND MICROBIOLOGICAL COMPLIANCE
BRIEF SYNOPSIS
Sterilisation methods have been in place for many
years. The challenge remains for manufacturers
to ensure compliance with microbiological
requirements. This workshop will provide information
on methods available under ISO 11137, including
recently updated ISO TS 13004. In addition guidance
will be outlined on importance of routine monitoring
and cleanroom comportment (ISO 14644).
Our technical expertise, experience and involvement
with ISO standards development have made us
a world leader in all aspects of microbiological
validation for products sterilised using irradiation.DATE: 21ST October 2015
WORKSHOP OUTLINE:
• Introduction to irradiation
• Proving a device is sterile
• Maintaining process effectiveness
• Future industry developments
• The microbiological validation regulations
• Dealing with failures and large complex devices
• Future standard developments
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STAY CONNECTED!FOR ALL THE LATEST NEWS AND EVENTS INFORMATION CONNECT WITH US:
@synergy_health
Synergy Health plc
/synergyhealthplc
www.synergyhealthplc.com/sterilisation
BRIEF SYNOPSIS
The need to understand and compare the available
technologies and take into account the regulatory
requirements is essential for any manufacturer of sterile
devices. The relationship between manufacturers and
sterilisation providers is an important element in assisting
with the production and supply of products to customers.
This sterilisation workshop will provide a valuable
overview of the available technologies as well as
guidance on understanding the factors needed to take
into account when considering sterilisation. It will also
examine approaches for validating these processes to
ISO Standards. Our courses are designed to give practical
guidance to the participants and to explore new cycle
design and regulatory requirements.
ETHYLENE OXIDE PROCESSING
WORKSHOP OUTLINE:• Introduction to EO
• Application of technology
• Validation of equipment and the EO process
• Routine processing
• Regulations
• Considerations
• Practical aspects of product validations
DATE: 14TH OCTOBER
WORKSHOPS
MEDICAL DEVICE CONFERENCE SYNERGY HEALTH WILL BE CO-HOSTING WITH ANECTO, OLIVER TOLAS, AND DUPONT.
BRIEF SYNOPSISThis one day conference will provide delegates with the opportunity to engage with industry experts on a range of subjects. Understanding the product journey is vital to help prevent in-warranty product returns, reduce costs and ensure product compliance. The aim of this conference is to provide delegates with an overview of all key elements of a product journey from concept to market. The day will start with presentations covering everything from the design process, ISO 11607, sterilisation to packaging materials and regulatory compliance. The afternoon sessions will feature workshops allowing delegates the opportunity to focus on specific topics of interest and overcome some of the
challenges being faced by manufacturers today.
WHO SHOULD ATTEND:
• R&D• Quality• Technical • Validation• Regulatory• Microbiology • Engineering• Process development • Planning
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WORKSHOPS CONFERENCES
VENUE: Parkhotel Horst, Horst THE NETHERLANDS
24TH SEPTEMBER 2015
PRICE: € 95
CONCEPT TO MARKET... AND EVERYTHING IN BETWEENGUIDING YOU THROUGH THE CHALLENGES AND IDENTIFYING SOLUTIONS TO DELIVER YOUR PRODUCT TO MARKET
CONFERENCE OUTLINE:
• Welcome & introduction
• Challenges and pitfalls with device/product development
• Standards/regulatory update
• Technology comparison
• How they get from concept to market
• Workshops (delegates to choose 2 x 1 hour sessions)
BRIEF SYNOPSIS
The Synergy Health (AST) Annual Conference 2016 will be focusing on topics associated with terminal sterilisation and aseptic manufacturing, with guest speakers together with our own in-house experts from Synergy Health.
The format for the day will follow our traditional conference route with presentations in the morning and workshops in the afternoon and there will also be opportunities to network with fellow delegates and speakers. To facilitate focused discussions on pertinent topics of interest relating to overcoming some of the challenges faced by industry in delivering products to the market.
VENUE: Parkhotel Stuttgart Messe Airport, GERMANY
1st March 2016
PRICE: €200 (€150 Early Bird rate 04.02.16)
WORKSHOP OUTLINE:14.00-16.00 Workshops: (delegates to choose 2 x 1 hour sessions)
OPTION 1:
OPTION 2:
OPTION 3:
OPTION 4:
Maintaining Compliance - the notified bodies perspective
Packaging Integrity - (Anecto)
Case Studies - working through your challenges - (Synergy Health)
Pyrogen Testing - changes
ANNUAL CONFERENCE
STRUGGLING TO FIND A TRAINING COURSE TO MEET YOUR STAFF AND ORGANISATIONS REQUIREMENTS?
Talk to us to about our bespoke training capabilities...
At Synergy Health we pride ourselves on our extensive level of technical expertise. Constantly striving to deliver even better understanding to our customers, we regularly update our skills base so that we can offer the best available advice.
We have a number of highly specialised training courses on all aspects of the sterilisation and associated microbiological testing and can tailor each of these courses to suit the individuals’ and organisations’ requirements.
We facilitate bespoke training either on site at one of our locations or we can bring the experts to you at your offices, delivering technical training to your staff and teams.
“In addition to our seminars and workshops, we also offer a full consultancy service from our microbiology team. From aiding with the planning of a new cleanroom to training new staff in relevant areas, in addition to product and technology advice for new sterilisation requirements. ”
Tailored group training from as little as: £225pp*
PAGE I 10WWW.SYNERGYHEALTHPLC.COM/STERILISATION
FOR MORE INFORMATION CONTACT US:
EMAIL: [email protected]
TELEPHONE: 08456 88 99 70
CALL US TODAY
TAILORED TRAININGANNUAL CONFERENCE
“We understand that each product has its own characteristic and sterilisation criteria. We therefore work with our clients to provide the most appropriate solution specifically tailored to the needs of the product and its application. ”
* PRICING DEPENDENT ON REGION
© Synergy Health 2016\ Ref: TC-01-16
www.synergyhealthplc.com/sterilisation
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