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An Enterprise Compliance Management Solution for Validation of your CS
20 April 2010
An Enterprise Compliance Management Solution for Validation of your CS

In association with

Rescop Logo

www.rescop.com

 

About the workshop

During this workshop Rescop B.V. will present their paperless compliance solution to how you can improve your compliance readiness of all your computerised systems throughout the total live cycle of each system.  You can reduce your validation costs and resources between 25% and 50% depending on your local situation.

The RC-ECMS system is a web-based solution that supply you a full control over all validation activities needed.  The system makes it possible to define your own validation approach for a given category and type of system.  A central validation dashboard gives you full control over all validation deliverables and the system will automatically initiate and trigger validation activities using your local email server.

 

About the workshop leader

 Piet Vervoort

P.E.M. Vervoort RE CISA, Managing Director, Rescop B.V.

Piet has a master degree within  IT-quality and has more than 25 years of experience within IT - his expertise is related to the quality of IT within a complex organization.  He has worked for  companies such as the Dutch Police Force, and in the financial industry and the pharmaceutical industry.  As a corporate IT-compliance officer he was responsible for the harmonisation  of 21 CFR Part 11 for the manufacturing sites of an international company.

 

About the organisation

Rescop B.V. (Regulatory system compliance partners) delivers innovative products and services to support companies in compliance of computerised systems with business and regulatory requirements.  Our products and services are applicable to companies operating in the pharmaceutical, chemical, veterinary, medical device, healthcare and animal feed industries which have to comply with GxP regulations.  Besides the RC-ECMS system Rescop also offers consultancy, audits and training in the area of validation of computerised systems.

Workshop agenda

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13:30

Registration and coffee

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14:00

Welcome and introductions

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14:10

Introduction of RC-ECMS

  • Challanges for the industry
  • Rescop philosophy for paperless compliance
  • Validation model of Rescop
  • Document versus content management
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    14:50

    Presentation of RC-ECMS: Part One

  • Configuration items
  • Asset and configuration management
  • Validation Master Plan
  • Establishing compliance
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    15:30

    Afternoon tea

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    15:50

    Presentation of RC-ECMS: Part Two

  • Establishing compliance
  • Maintaining compliance
  • Scheduling and triggering
  • Electronic logbook
  • Pricing and hosting
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    16:30

    Discussion session

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    17:00

    Close of workshop

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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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    Opening Hours: 9.00 - 17.30 (local time)
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