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SMi proudly presents the half-day interactive workshop at Pre-Filled Syringes West Coast in San Diego, USA in June 2016!

This workshop will cover the regulatory requirements for human factors work on medical devices, comparisons between the regulatory requirements between the US and the EMEA region, and discuss when, and how, to go about planning human factors activities.

Stay up to date on human factors regulatory requirements, including:

  • New FDA guidance published in February 2016
  • Understand how to meet these requirements during the development of your products

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

Pre-Filled Syringes/ PFS
Medical Device
Device Delivery
Aseptic Processing
from pharmaceutical and biotech only

Workshop LEADER


Shannon Clark

Founder & CEO, UserWise



Shannon Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants a UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

Before UserWise, Shannon was a Human Factors Engineer at Intuitive Surgical, where she worked on da Vinci surgical systems, instruments, and accessories including the da Vinci Xi System.

In 2012, Shannon completed Abbott Laboratories' Professional Development Program, working in various supervisory, R&D, Quality and Regulatory functions in divisions including Abbott Vascular, Abbott Diagnostics, Abbott Diabetes Care, and Abbott Medical Optics.

Shannon graduated in 2010 from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.

Successful product development requires a balance of usability, usefulness and desirability. Core's human factors methodologies uniquely address this balance.

Core has vast experience with consumer, industrial and healthcare-related products. The latter, in particular, requires an exceptional amount of risk management for regulatory compliance and liability control, all of which Core can successfully accomplish.



Workshop programme

8:00 Registration & Coffee

8:30 Workshop Leader's Opening Remarks

8:40 Regulatory Update – US vs. EU

9:30 Coffee Break

10:00 How to Conduct Your Studies to Ensure Compliance?

11:00 Case Study

11:30 Q&A

12:00 Workshop Leader Closing Remarks & End of Workshop


Hyatt Regency Mission Bay

1441 Quivira Road
San Diego 92109

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.



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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.


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.


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.


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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