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Training & Workshops

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At SPD we provide a number of relevant forums for

skills development, primarily through our mentoring

programme and Techgistics© series of workshops

in the pharmaceuticals and medical

devices space.

 

  • The Techgistics Workshop

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    The Techgistics© Workshop Series was developed specifically to address critical

    knowledge gaps within these highly

    technical specialist industries.

     

    Our approach is to simulate 'real -life' situations as closely as possible. Your company can experience these workshops in different forums

     

    Open forums which allow sharing of ideas with industry peers.

     

    Closed company-only forums, either on-site or at an external venue.

     

     

    Techgistics© Workshops are available in a number of platforms, namely

     

    • Off-the-shelf (ready-to-go) workshops.
    • Partially-customised workshops which are based on an existing topic, with Case Studies relevant to your company situations.
    • Fully-customised workshops typically constructed on a problem area or situation currently experienced by your company.

     

     

    We’ve worked internally with local, North American and European clients, as well as with educational institutions such as Box Hill TAFE, UTS, UNSW and industry associations to develop tried and tested workshops much-needed by our industry.

     

    As a result, we are able to offer you a wide repertoire of learning themes in the Techgistics© Workshop Series, such as:

     

    • Medical Devices Unplugged – helping minimise the chances of TGA rejection.
    • Dossier Gap Analysis – will your dossier make the grade?
    • Product Development & Launch Processes in a Highly-regulated Industry.
    • An Intro into Regulatory Affairs, covering prescriptions, OTCs and Medical Devices.
    • Regulatory Affairs for non-Regulatory People.
    • Introduction to the Regulation of Medical Devices.
    • How to Create and Review Dossiers to Register Sterile Products.
    • Conformity Assessment Procedures for Medical Devices.
    • Project Management in a Technical and Highly Regulated Industry
    • Planning for commercialisation.
    • Conducting Due Diligence.
    • Marketing in a Highly-Regulated Environment.
    • Supply Chain.
    • QbD.
    • Quality.
    • Drug Discovery – where it all begins.
    • Risk Assessment - a practical "how-to" guide.

     

     

  • Customised Workshops & Training

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    In addition to our state-of-the-art workshop,

    the Techgistics© Workshop can be customised for

    individual company needs on request. These can

    be held at a location of choice.

    Examples of workshops that can be modified to meet the company's specific needs include

     

    How to select the right product for development.

     

    Managing the process to launch and beyond.

     

    Customised workshops for specific industries, i.e. understanding regulations and creating systems to meet them.

     

    Implementing standard techniques for dossier preparation and submission, e.g. SOPs and checklists.

     

    "How to" workshops covering the setting up and maintaining of quality management systems.

     

    Trouble-shooting techniques and how to apply them (generic, or customised to specific problems).

     

    Facilitate a "What can go WRONG?" workshop using the company expertise.

     

    "How to" workshop on conducting a feasibility or due diligence study.

     

     

  • On-the-job Mentoring

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    In terms of Mentoring, we offer flexible support whether it be on-site, on-the-job “hand-holding”

    to periodic feedback and sounding board

    sessions, and either face-to-face

    or telephonically.

     

    Locating talented staff with the right skills set is becoming increasingly difficult in the competitive market for high performers.

     

    One strategy to overcome this is to hire people with great potential, but who may be deficient in some or all of the required skills.

     

    A number of our experts are also skilled mentors, happy to share our extensive knowledge.

     

    We take pride in developing up-and-coming staff who are growing into their new roles, or acting as soundboards in the executive decision-making process.

     

     

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Email

theSPDco@bigpond.net.au

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linkedin.com/in/clive-simon-spdco

Telephone

0402 546 792

Address

PO BOX 1915 Macquarie Centre NSW 2113 Australia

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