Training Programme 2015

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1 Training Programme 2015

2 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. CONTENTS PAGE Webinars 3 Workshops 5 Conferences 8 Annual Conference 9 Tailored Training 10 FOR ALL OUR LATEST NEWS AND EVENT INFORMATION FOLLOW 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. FOR MORE INFORMATION CONTACT US:

3 COGENT GOLD STANDARDS PROGRAMME Synergy 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

4 WEBINARS 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 We are uniquely positioned to provide expert insight into a range of topics relating to our technologies CONTACT US TO REGISTER YOUR INTEREST:

5 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 Our events provide the core knowledge required in industry today on all modern sterilisation techniques 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 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. Processing capabilities Comparison with other processing technologies Practical aspects and considerations Benefits of x-ray For the latest webinar dates please visit our website. PAGE I 4

6 WORKSHOPS With 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 WORKSHOPS AVAILABLE: Radiation sterilisation of medical devices Ethylene Oxide processing ISO validation and microbiological compliance Group discount available CONTACT US TO BOOK YOUR PLACE:

7 RADIATION STERILISATION OF MEDICAL DEVICES 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. ISO VALIDATION AND MICROBIOLOGICAL COMPLIANCE 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 DATE: 16 TH SEPTEMBER NOVEMBER (TBC) 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 DATE: 21 ST October 2015 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 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. PAGE I 6

8 WORKSHOPS ETHYLENE OXIDE PROCESSING 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. 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: 14 TH OCTOBER STAY CONNECTED! FOR ALL THE LATEST NEWS AND EVENTS INFORMATION CONNECT WITH Synergy Health plc /synergyhealthplc

9 CONFERENCES MEDICAL DEVICE CONFERENCE SYNERGY HEALTH WILL BE CO-HOSTING WITH ANECTO, OLIVER TOLAS, AND DUPONT. This 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. 24 TH SEPTEMBER 2015 PRICE: 95 VENUE: Parkhotel Horst, Horst THE NETHERLANDS WHO SHOULD ATTEND: R&D Quality Technical Validation Regulatory Microbiology Engineering Process development Planning PAGE I 8

10 ANNUAL CONFERENCE CONCEPT TO MARKET... AND EVERYTHING IN BETWEEN GUIDING YOU THROUGH THE CHALLENGES AND IDENTIFYING SOLUTIONS TO DELIVER YOUR PRODUCT TO MARKET 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. 1 st March 2016 PRICE: 200 ( 150 Early Bird rate ) VENUE: Parkhotel Stuttgart Messe Airport, GERMANY CONFERENCE OUTLINE: Welcome & introduction WORKSHOP OUTLINE: Workshops: (delegates to choose 2 x 1 hour sessions) OPTION 1: OPTION 2: Packaging Integrity - (Anecto) OPTION 3: Maintaining Compliance - the notified bodies perspective Case Studies - working through your challenges - (Synergy Health) OPTION 4: Pyrogen Testing - changes 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)

11 TAILORED TRAINING 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. Tailored group training from as little as: 225pp* * PRICING DEPENDENT ON REGION CALL US TODAY 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. 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. FOR MORE INFORMATION CONTACT US: TELEPHONE: PAGE I 10

12 Our Vision To build a lasting reputation as the trusted experts in global healthrelated markets by differentiating our services and products through the way we work. Achievement We believe our success comes from our focus on exceeding expectations and our commitment to go that extra mile, however small the difference may seem. Accountability We take personal responsibility for our actions and are equipped to take the right course of action. Integrity We believe that the way we work is as important as what we do. We care deeply about the quality of our work and inspire trust by delivering on promises. Innovation We achieve the best possible results by working with customers to develop new ways of solving problems and reducing risk. Synergy Health 2016\ Ref: TC-01-16

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