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With increasing focus on patient satisfaction, it has become essential to control and understand siliconization in pre-filled syringes. This comprehensive training program will teach you how to put quality at the  heart of your product specification, and provide you with the key learning points and information needed, for you to control and validate the quality parameters in a pre-filled syringe.

By attending this workshop, you will be able to generate and measure accurate information about the quantity, quality and distribution of the silicone layer in your parenteral primary packaging, such as syringes, cartridges and vials. Equipping you with the ability to demonstrate the value and quality of your product in the industry.

  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers
     

3P INNOVATION LTD; AbbVie Ltd; addey and stanhope school; Affibody AB; Aptar; APTAR PHARMA; Ascendis Pharma GmbH; Aspen Pharmacare; AstraZeneca; B. Brauná; BA Consultancy; BAUMANN SPRINGS LTD; Bayer Pharma AG; Becton Dickinson; Bespak Innovation; Biocorp; Biopharm Insight; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Cambridge Consultants Ltd; Colwill Health Ltd.; Consillient Health; DATWYLER PHARMA PACKAGING INTERNATIONAL NV; Datwyler Schweiz AG; DTP Holding; E3D ACA Ltd; F. Hoffmann-La Roche Ltd.; Formycon AG; FRUH VERPACKUNGSTECHNIK AG; Galderma; GALDERMA R&D; Genentech, Inc.; Gerresheimer; Glenmark Pharmaceuticals S A; GROUPE JBT; GSK; GSK R&D; Guerbet; Intertek (Schweiz) AG; Laboratoire Aguettant; LEO Pharma; LEO Pharma A/S; LFB Biotechnologies; LRQA; Medical Device Usability Ltd; MET; MHRA; Midatech Pharma; Mikron S A Boudry; MINAKEM SAS; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mylan; Mylan, Inc.; Nemera; New Injection Systems Ltd; Nipro Europe NV; Nolato Medical; Novartis; Novartis Pharma AG; Octapharma; Owen Mumford; Owen Mumford Ltd.; Pfizer; PFIZER CenterOne; Pharmaceutical Systems; Pharmacircle; Pharmis Biofarmaceutica Lda; Phillips-Medisize; Pliva; Roche; Samedan Ltd ; Sandoz; Sanofi S A; Sanofi-Aventis; SCHOTT; SCHOTT AG; SCHOTT Schweiz AG; Shire; SiO2 Medical Products; teamtechnik Maschinen & Anlagen GmbH; Terumo ; Terumo Europe; Terumo Europe N.V.; Terumo Europe NV; Teva-Pliva; TOPAS Advanced Polymers GmbH; Trinseo Deutschland GmbH; UCB; UCB Celltech; Vetter Pharma International GmbH; W.L. Gore & Associates, Inc.; Weidmann Medical Technology AG; West Pharmaceutical Services; West Pharmaceutical Services Deutschland GmbH & Co. KG; Worrell; Ypsomed AG; Zeon Europe GmbH; Zwick Testing Machines Limited;

Workshop LEADER

keynote-img

Oliver Valet

Co-Founder, rap.ID Particle Systems GmbH

Dr. Valet is the co-founder of rap.ID Particle Systems GmbH, which develops manufactures and sells rapid particle identification systems. rap.ID's technology has combined particle isolation, imaging analysis and spectroscopic technologies, creating investigative tools for particle identification and characterization. Dr. Valet has extensive experience in foreign particulate matter testing and Root Cause investigation. He has also worked on the development of accurate and reproducible technologies for characterizing silicone oil layer thickness, and its distribution in parenteral packaging materials.

rap.ID Particle Systems GmbH

Rap.ID is the technological leader in the control of lubricant films and identification of foreign particulate matter (FPM). In Europe, rap.ID operates as the most preferred contract testing laboratory for FPM ID in parenteral drug products.  Rap.ID Inc. has years of invaluable experience and knowledge in regards to customized application development and analysis services.

Workshop programme

13:30 Workshop Registration

14:00 Workshop Leader Introduction

Oliver Valet

Oliver Valet, Co-Founder, rap.ID Particle Systems GmbH
View Bio

14:15 Session One: Application of silicone oil and the siliconisation process

  • Different methods of silicone application; spray on and baked on
  • Results from static and dynamic siliconization processes
  • Impact on parameters on baked silicone oil
  • What is the difference and how does siliconization work?
  • Lisa Krapf

    Lisa Krapf, Application Scientist , rap.ID Particle Systems GmbH
    View Bio

    Oliver Valet

    Oliver Valet, Co-Founder, rap.ID Particle Systems GmbH
    View Bio

    14:45 Session Two: Silicone layer characteristics

  • From 'dust test', gravimetric extraction and force displacement measurements to image analysis and bubble counting
  • Advantages and limitations of different techniques
  • What do the measurement results mean?
  • Discussion
  • Lisa Krapf

    Lisa Krapf, Application Scientist , rap.ID Particle Systems GmbH
    View Bio

    Oliver Valet

    Oliver Valet, Co-Founder, rap.ID Particle Systems GmbH
    View Bio

    15:30 Afternoon Tea and Networking Break

    16:00 Session Three: Layer Explorer technology and results

  • Technology, traceability and reproducibility
  • Comparison with other siliconization measurements
  • Resolution and accuracy of the measurement
  • Measurement results and limitations
  • what are the advantages of the state of the art lubrication control and investigation strategy?
  • Oliver Valet

    Oliver Valet, Co-Founder, rap.ID Particle Systems GmbH
    View Bio

    Lisa Krapf

    Lisa Krapf, Application Scientist , rap.ID Particle Systems GmbH
    View Bio

    16:30 Session Four: Case studies and investigations

  • Examples of silicone thickness and distribution and stability measurement in pre-filled syringes and baked-on cartridges
  • Product stability studies
  • Control suppliers quality
  • How can I prevent actual problems and what is the right investigation strategy?

     

  • Protein particle investigations
  • Raman spectroscopy and image analysis of particles
  • Relationship between inhomogeneous silicone oil distribution and protein aggregation
  • Breakout session; How can I measure the relationship between silicone oil and protein aggregation in my product?
  • Oliver Valet

    Oliver Valet, Co-Founder, rap.ID Particle Systems GmbH
    View Bio

    Lisa Krapf

    Lisa Krapf, Application Scientist , rap.ID Particle Systems GmbH
    View Bio

    17:00 Workshop Leader Closing Remarks and Close of Workshop

    +

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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