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Electronic Document Management Systems
9 December 2010
Electronic Document Management Systems

Electronic Document Management Systems

In association with

 GxPi logo

www.gxpi.com

 

Why should you attend this event?

By attending this Masterclass, you will be able to

  • Prepare your organisation for an eDMS
  • Design an implementation process
  • Identify the best validation strategies for your eDMS
  • Maximise the benefits of an eDMS for your organisation

Where does the event take place?

This Masterclass will take place in central London, UK.

What is this event about?

It is widely recognised that an electronic document management system can save your business time and money, while leaving your documents safer yet more easily retrievable and searchable.  However, planning and implementing an eDMS is a complex operation and needs to be done correctly to ensure a smooth transition from paper to microchip for your documents and also for your staff.  Maintaining a validated state throughout the change process is crucial, as is educating your staff to use the new eDMS to its fullest potential.

The workshop will look at procedures for ensuring your organisation and documents are ready for the transition and at strategies for designing and implementing your eDMS.

Scroll down for the full programme...

 

Who is leading this event?

The Masterclass is being led by Jonathan Burd, Solutions Director, GxPi.

A pharmacist by background, Jonathan has 30 years of experience working in healthcare and life sciences.  After working for 15 years in the NHS, Jonathan moved into consultancy and software development, where he has undertaken a wide variety of roles.  For the last 10 years, prior to joining GxPi, Jonathan has been involved in providing enterprise content management solutions into the Life Sciences market on industry-leading products based on the Documentum and SharePoint platforms.  He brings this experience to GxPi to provide further domain input to the x-docs™ product development as well as consulting and subject matter expert support to project implementations.

GxPi 

GxPi was founded in 2000 to address a growing need in the Pharmaceutical, Biotechnology and Life Sciences sectors to improve business efficiency, and comply with increasing regulatory and legal pressures. Our aim is to provide high-value, high-impact results-focused services and software solutions in a simply compliant way.
 
The founders have many years of experience in delivering software services and solutions to large corporations, and believe that the Healthcare Sector is growing significantly due to the emergence of the small and mid-sized enterprises.

These companies need pragmatic advice and regulatory support.  They also have to have the same compliance hurdles for electronic document and electronic content management that large bio and pharma have.  Their solutions need to be easy to use and administer, keep the regulators and auditors satisfied, and be implemented, and validated quickly with low sponsor company resource input.

 

Who should attend this event?

Chief Executives, Vice Presidents, Heads, Directors, and Project Leaders of

  • Document and Records Management
  • Standards Implementation
  • Regulatory Affairs
  • Quality Assurance and Compliance
  • IT and Support
  • Contract Research and Service Support
  • Validation
  • Pharmacovigilance
  • IP

Masterclass agenda

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9:30

Registration and coffee

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10:00

Welcome and introductions

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10:10

How ready is your organisation for an eDMS?

  • Organisational readiness assessment - what shape is your organisation in to take on an eDMS and its processes?
  • Identifying the main points and potential blockages before an implementation starts
  • Avoiding interference with people's everyday work
  • clock

    10:40

    Designing and specifying an eDMS that is fit for purpose

  • What do you need the system to do?
  • What do you need from the system? 
  • How to structure the Requirements Specification to get the right configuration first time
  • clock

    11:20

    Implementing the eDMS

  • Key steps for implementation
  • How to avoid the major pitfalls
  • clock

    12:00

    Document readiness

  • How to prepare your existing documentation and legacy systems
  • Ensuring an efficient transfer of documentation into the new environment
  • clock

    12:30

    Lunch

    clock

    13:30

    Validation of the eDMS

  • Guidance on the best approaches and strategies
  • clock

    14:15

    User adoption

  • Ensuring the eDMS is understood and used by the business to its full potential
  • clock

    15:00

    Case Study examples

    clock

    15:45

    Discussion and questions

    clock

    16:00

    Close of masterclass

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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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