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Training Programme 2015

Synergy Health AST EMEA Training Programme 2015

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Page 1: Synergy Health AST EMEA Training Programme 2015

Training Programme 2015

Page 2: Synergy Health AST EMEA 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.

Page 3: Synergy Health AST EMEA Training Programme 2015

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 ”

Page 4: Synergy Health AST EMEA Training Programme 2015

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

Page 5: Synergy Health AST EMEA Training Programme 2015

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 ”

PAGE I 4

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

Page 6: Synergy Health AST EMEA Training Programme 2015

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]

Page 7: Synergy Health AST EMEA Training Programme 2015

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

PAGE I 6

Page 8: Synergy Health AST EMEA Training Programme 2015

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

Page 9: Synergy Health AST EMEA Training Programme 2015

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

PAGE I 8

WORKSHOPS CONFERENCES

VENUE: Parkhotel Horst, Horst THE NETHERLANDS

24TH SEPTEMBER 2015

PRICE: € 95

Page 10: Synergy Health AST EMEA Training Programme 2015

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

Page 11: Synergy Health AST EMEA Training Programme 2015

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

Page 12: Synergy Health AST EMEA Training Programme 2015

© Synergy Health 2016\ Ref: TC-01-16

[email protected]

www.synergyhealthplc.com/sterilisation

To build a lasting reputation as the trusted experts in global health-related markets by differentiating our services and products through the way we work.

AchievementWe believe our success comes from our focus on exceeding expectations and our commitment to go that extra mile, however small the difference may seem.

AccountabilityWe take personal responsibility for our actions and are equipped to take the right course of action.

IntegrityWe 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.

InnovationWe achieve the best possible results by working with customers to develop new ways of solving problems and reducing risk.

Our Vision