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SAE Media Group’s 3rd Annual Conference
Pre-Filled Syringes San Francisco
September 19 - 20, 2022 | San Francisco, CA, USA
Workshop: September 21, 2022 | San Francisco, CA, USA
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Denise Forkey and the UserWise team regularly consult with medical device and combination product companies in the development of user instructions and assessing those instructions as part of usability studies. In this workshop, we will present relevant case studies and our best practices for developing effective instructional material for combination products to ensure safe and effective product use.

  • An overview of types of user documentation and associated regulatory requirements
  • How to develop easy-to-use instructions for use from the get-go and reduce the formative testing burden 
  • How to design out-of-box experience
  • Best practices and case studies related to IFU development
  • Hands-on practice developing and conducting an expert review of instructions for use

 

  • Drug-delivery device 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:


 

 

Alexion Pharmaceuticals; Almac Group; Amgen; Amgen Inc; Amgen Inc.; Amgen, Inc.; AnaptysBio; Ascendis Pharma; AstraZeneca; Biogen; Boston Analytical Inc; Coherus Biosciences; Corning Inc; Corning, Inc.; Eagle Pharmaceuticals; Eagle Pharmaceuticals, Inc.; Eli Lilly and Company; Genentech; Genentech, Inc.; Glenmark Pharmaceuticals Inc.; Janssen Pharmaceuticals; Janssen R&D; Jazz Pharmaceuticals; Johnson & Johnson; Johnson & Johnson - Janssen; Johnson & Johnson Research & Development; Merck; Merck & Co. Inc.; Minapharm Pharmaceuticals; Pfizer; Pfizer Inc.; Pfizer, Inc; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals Inc; Regeneron Pharmaceuticals, Inc.; Sanofi Pasteur; Takeda; Takeda Pharmaceutical Company Limited; U.S. Food and Drug Administration; UserWise, Inc.; Zacros America, Inc.; Zeon Corporation; Zeon Specialty Materials ; Zeon Specialty Materials Inc;
 

Workshop LEADER

keynote-img

Denise Forkey

Director, Human Factors, UserWise, Inc.

Denise Forkey is currently Director, Human Factors at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups to design safe and easy-to-use medical products. She leads a team of human factors consultants who fulfil any and all aspects of the usability engineering process.

Denise has experience performing use-related risk analyses, conducting usability testing, designing instructions for use and implementing the usability engineering process for home-use injection products through complex robotic surgery system. Denise regularly works on human factors submission strategy and compliance documentation for FDA Human Factors Guidance, and international standards related to usability engineering (e.g., IEC 62366-1, IEC 60601-1-6, and ISO 14971). She has helped numerous UserWise clients successfully navigate FDA human factors submissions, create usability documentation for CE mark, and manage notifying body and test lab audits of the usability engineering file. Denise has been working in the medical products industry for more than 25 years and has experience in medical device testing and quality systems/engineering, with her last 6 years focusing on human factors engineering processes and testing.

She holds a master’s degree in Biomedical Engineering and has severed as a board member of the national Biomedical Engineering Society and the Bio2Device group and was the founding President of the San Francisco Bay Area Chapter of the Biomedical Engineering Society.
 

Workshop programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Denise Forkey

Denise Forkey, Director, Human Factors, UserWise, Inc.
View Bio

9:10 User documentation and associated regulatory requirements

Denise Forkey

Denise Forkey, Director, Human Factors, UserWise, Inc.
View Bio

  • General overview of different regulatory documents, standards and guidance that apply to combination product Instructions
  • Review of different types of user documentation and special considerations
  • Review of regulatory requirements for Instructions
  • 9:25 Optimizing instructions for use to reduce the testing burden

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

  • How to develop easy-to-use instructions for use from the get-go and reduce the formative testing burden?
  • 9:40 Designing for out-of-box experience

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

  • What is out-of-box experience?
  • How to design Instructions for optimal out-of-box experience?
  • 10:00 Morning Coffee

    10:10 Best practices and case studies related to IFU development

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

  • Do’s and Don’ts of designing Instructions
  • Case studies on designing packaging/Instructions for out-of-box experience
  • Case studies on optimization of the Instructions
  • 11:10 Evaluating Instructions in Usability Testing

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

  • Evaluation of Instructions in Formative Testing to minimize Validation Risks
  • Evaluation of Instructions in Validation Testing
  •  

    11:30 Hands-on Practice

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

  • Presentation of an Instructions Review Checklist
  • Hands-on practice developing and conducting an expert review of instructions for use
  • 12:10 Q&A

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

    12:30 Closing Remarks and End of Workshop

    Denise Forkey

    Denise Forkey, Director, Human Factors, UserWise, Inc.
    View Bio

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    VENUE

    Hyatt Centric Fisherman’s Wharf San Francisco

    555 North Point St, San Francisco, CA, USA

    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 SAE Media Group. SAE Media 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 Centric Fisherman’s Wharf San Francisco

    555 North Point St
    San Francisco 94133
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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, SAE Media 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@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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