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This workshop will provide an overview of human factors validation strategies that companies should consider as the pre-filled syringe market increasingly takes on digital health components. A case study of a pre-filled syringe with connection to a mobile app will be utilized throughout the course to demonstrate the concepts under discussion and help participants work through a study plan. The workshop aims to generate discussion around challenges, lessons learned, and future directions for human factors considerations regarding similar products

  • Hear regulatory and industry perspectives on study design for pre-filled syringes
  • Understand current FDA thinking on human factors submissions
  • Discuss considerations for products incorporating digital health

Executives, Directors, VPs, Heads, Principals, Managers of:

Pre-Filled Syringes/ PFS
Autoinjectors
Device/ Device Engineering
Human Factor
Container Closure Integrity
Scientist
CMC
Product
Injectables
Sterile Manufacturing
Packaging
Regulatory Affairs

or anyone who works with Pre-Filled Syringes/ Autoinjectors within pharmaceutical, biotech and solution providers.

Abbott Laboratories; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Höfliger; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune Inc; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical America Inc; MITSUBISHI GAS CHEMICAL COMPANY, INC; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services,; West Pharmaceutical Services, Inc.; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON; ZEON CORPORATION; Zeon Specialty Materials Inc;

 

Workshop programme

13:00 Registration & Coffee

13:30 Opening Remarks and Introductions

Natalie Abts

Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
View Bio

Rita Lin

Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

13:40 Overview of Human Factors Guidance Documents

  • Review FDA human factors guidance Applying Human Factors and Usability Engineering to Medical Devices
  • Review Xcertia mHealth App Guidelines and discuss relevance to pre-filled syringe industry
  • Discuss current directions and challenges with pre-filled syringes from regulatory and industry perspectives
     
  • Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts

    Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
    View Bio

    14:20 Case Study Introduction

  • Case study product overview – testing a pre-filled syringe utilizing Bluetooth to communicate with an accompanying app
  • Discussion of risk analysis and risk considerations for this type of product
  • Preliminary discussion and review of product documentation
     
  • Natalie Abts

    Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
    View Bio

    Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    15:00 Afternoon Tea

    15:30 Validation Study Planning

  • Discuss key components of a good validation study design
  • FDA perspective on common problems with validation plans
  • Industry perspective on problem-solving for difficult-to-test products
  • Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts

    Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
    View Bio

    16:10 Creating a Study Plan

  • Work time to create a validation study plan for the device introduced during Session 2
  • Team report out of study plans
  • Discussion of lessons learned from the exercise
  • Natalie Abts

    Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
    View Bio

    Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    16:50 Closing Remarks from Workshop Leaders and End of Workshop

    +

    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    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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