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Testing of Drug Delivery Devices
15 June 2022
Testing of Drug Delivery Devices

SAE Media Groups 6th Annual Conference
Pre-Filled Syringes West Coast
June 13 - 14, 2022 | San Diego, CA, USA
Workshop: June 15, 2022 | San Diego, CA, USA
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SAE Media Group is delighted to announce the 6th annual Pre-Filled Syringes West Coast conference, to be held in San Diego. As part of SAE Media Group’s leading series of drug delivery device conferences, the 2022 event will provide insights into the rapidly accelerating market of combination product development with industry, device developer and regulatory perspectives.

 

Prefilled syringes and autoinjectors are devices that are prone to failure due to their complex action mechanics and sensitivity to storage. Due to high risk, these devices are strictly regulated by international standards.

Knowing the applicable standards is only one step. Companies must first develop a validation master plan. The key elements of this plan include a user requirements specification (URS), a risk Assessment (RA), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
 

Workshop LEADER

keynote-img

Michael Goehring

Medical & Pharmaceutical Industry Manager, ZwickRoell

BSEE – Instrumentation and System – University of Connecticut, School of Engineering

Field Systems Engineer for materials and component test systems
Territory Manager for Laboratory Information Management Systems
District and Regional Sales Manager for materials and component test systems
America’s Sales Manager for material preparation and analysis
Medical & Pharmaceutical Industry Manager – Testing Solutions

ZwickRoell

ZwickRoell has years of experience in delivering innovative solutions for the testing of drug delivery systems that reduce operator influence, which increases accuracy, repeatability, reproducibility, and traceability of test results. ZwickRoell’s qualification services bridge include DQ to a URS, IQ, OQ, and soon we will be able to assist in the PQ Test Plan.

Workshop agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

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9:10

Drug Delivery Device Overview

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

  • Applicable ISO standards and referenced UPS
  • Standard V Model from URS to PQ
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    9:50

    (Prefilled) Syringe Testing and Spring Simulation

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

  • ISO 11040-4, -6, -8
  • “Live” performing a Break Loose / Glide Force Test
  • User influences and how to reduce or eliminate?
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    10:30

    Morning Coffee

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    11:00

    Autoinjector and Pen Injector Testing

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

    • Pen Injectors – Manual Dose or Automated Dosing – ISO 11608-3
    • Autoinjectors - Full function tests – ISO 11608-5
    • Wearables – ISO 11608-6

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    11:40

    Regulatory Demands

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

  • 21 CFR Part 11 – Traceability (When, Who, What, Why and Who is Responsible
  • Configuring Traceability and User Rights
  • DQ, IQ, OQ and PQ
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    12:20

    Closing Remarks

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

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    12:30

    Close of Workshop

    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, 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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    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
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