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SMi is proud to announce the inaugural Prefilled Syringes San Francisco Virtual Conference taking place in September 2020.
 

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human factors studies and innovative design and delivery systems within the prefilled syringes industry.

As part of SMi's leading Injectable conference series, we will assess digital health and connected devices, biologics, biosimilars and biocompatibility for drug/device combination products, platform and device selection, regulatory insights and hear from the West Coast's biotech innovators.

 

Risk management is central to the development of any medical device or combination product. Integration of Human Factors Engineering processes into the development of your device ensures the prioritization of safety and efficacy when in the hands of the end user. This workshop will teach best practices in identifying use errors and analysing risks stemming from use of medical products. We will review pertinent definitions and strategies for determining use-related risk and perform exercises to train these skills.

  • Integration of Human Factors Engineering processes in risk management saves time and money in product development 
  • Effective identification of use-related risk helps inform constructive design decisions
  • Mitigation of use-related risk improves treatment outcomes for end users 
  • Understanding the methods used to assess use-related risk will improve the efficiency and acumen of your organization
     
  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

Previous attendees include:
 

 

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc;

 

Workshop programme

13:30 Opening Remarks

Denise Forkey

Denise Forkey, Senior Human Factors Engineer, UserWise, Inc.
View Bio

Miles Buroker

Miles Buroker, Human Factors Engineer, UserWise, Inc.
View Bio

13:40 Session 1

  • Use-related risk analysis overview
  • Key definitions from standards and guidance
  • Denise Forkey

    Denise Forkey, Senior Human Factors Engineer, UserWise, Inc.
    View Bio

    Miles Buroker

    Miles Buroker, Human Factors Engineer, UserWise, Inc.
    View Bio

    14:20 Session 2

  • Use error vs. User error
  • Exercise: Case Studies in Use error vs. User error
  • Denise Forkey

    Denise Forkey, Senior Human Factors Engineer, UserWise, Inc.
    View Bio

    Miles Buroker

    Miles Buroker, Human Factors Engineer, UserWise, Inc.
    View Bio

    15:10 Session 3

  • PCA task analysis
  • Authoring a use-related risk analysis
  • Identifying critical tasks
  • Use-related risk analysis best practices
  • Assessing risk acceptability
  • Denise Forkey

    Denise Forkey, Senior Human Factors Engineer, UserWise, Inc.
    View Bio

    Miles Buroker

    Miles Buroker, Human Factors Engineer, UserWise, Inc.
    View Bio

    15:50 Afternoon Break

    16:30 Session 4

  • Exercise: Authoring line items in a use-related risk analysis
  • Denise Forkey

    Denise Forkey, Senior Human Factors Engineer, UserWise, Inc.
    View Bio

    Miles Buroker

    Miles Buroker, Human Factors Engineer, UserWise, Inc.
    View Bio

    16:50 Closing Remarks

    Denise Forkey

    Denise Forkey, Senior Human Factors Engineer, UserWise, Inc.
    View Bio

    Miles Buroker

    Miles Buroker, Human Factors Engineer, UserWise, Inc.
    View Bio

    17:00 End of Workshop

    +

    FEATURED SPEAKERS

    Denise Forkey

    Denise Forkey

    Senior Human Factors Engineer, UserWise, Inc.
    Miles Buroker

    Miles Buroker

    Human Factors Engineer, UserWise, Inc.

    Denise Forkey

    Senior Human Factors Engineer, UserWise, Inc.
    Denise Forkey

    Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

    Miles Buroker

    Human Factors Engineer, UserWise, Inc.
    Miles Buroker

    Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

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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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