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Having run highly successful CSV conferences in the past, in 2010 SMi are revisiting the issue of Computer Systems Validation in the Pharmaceutical Industry to look at whether the pharmaceutical industry could change its attitude towards CSV, so that it is done sensible, effectively and practically.

Taking place in London, UK, this conference will focus on a wide range of issues withing the CSV arena, including the regulatory aspects to CSV - whether the current guidelines need expanding, reinterpreting or rewriting - CSV in an R&D context, the need for a risk-based approach to CSV, the respective benefits of doing CSV in-house or contracting it out, and developing a 'bigger picture' approach to CSV.

Questions examined during the conference will include: what is the role of QA departments?  How much CSV is enough?  Does CSV hamper clinical R&D?  Should all CSV be risk-based in analysis?  Should the industry use a consortium approach to vendor-CSV audit?  Are consultants too widely used - would CSV be done better in-house?  What are the CSV implications for mergers?  How to develop a quality model?

Attend this event to discover how computer systems validation does not have to be difficult, time-consuming and costly, and to learn how to plan for better implementation of a CSV programme.

Fancy speaking at the conference?  Do you know of anyone who may be interested in speaking?  We are always on the look-out for new speakers for our upcoming conferences.  Let us know: smiproduction@smi-online.co.uk.

For sponsorship and exhibitioning opportunites, contact  sponsorshipdept@smi-online.co.uk.

 

Delegates at this conference will learn about

  • Developing an overall quality model
  • Different perspectives on CSV - regulators, industry, consultants, QA departments
  • Mergers and CSV
  • CSV in clinical research and development
  • Risk-based approaches to CSV
  • Maintaining a validated state and auditing CSV programmes
  • CROs and CSV - regualtory implications
  • Using consultants vs in-house CSV

 

 Computer
 Floppy Discs

How you will benefit from attending this conference

Hear from some of the most important and influential experts working in CSV

Learn about implementing a 'bigger picture' approach to CSV and reducing the administrative burden

Study how the biggest players in the industry implement CSV - and learn lessons for your sector

Network with people you need to know in the CSV world

 

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

  • Systems Validation
  • Information Technology 
  • Quality Assurance
  • Quality Control
  • Data Management
  • Auditing
  • Compliance
  • Regulatory Affairs
  • Research and Development
  • Laboratory Systems Management
  • Software Quality Engineering
  • Project Development
  • Clinical Systems
  • Scientific Affairs

 Delegates at our previous CSV conferences came from across the world

Graph of delegate countries

 

Conference programme

8:30 Registration & coffee

9:00 Chairman's opening remarks

Mark Stevens

Mark Stevens, Managing Director, GxPi

9:05 OPENING KEYNOTE: HOW CAN WE APPLY 'LEAN THINKING' TO CSV?

Henrik Olsson

Henrik Olsson, Clinical IS Quality & Compliance Team Leader, AstraZeneca

  • The lean approach to achieve quality, a brief overview of how companies apply lean to get it right first time.
  • Translating lean philosophies and principles into the CSV area
  • Challenges in a regulated environment
     
  • 9:40 THE ROLE OF QA DEPARTMENTS

    Trev Simmons

    Trev Simmons, Founder, A1 IT Compliance

  • What is the role of QA in CSV?
  • Where does CSV fit into the quality model?
  • What tools can be used to expedite CSV?
  • Minimum documentation requirements
  • 10:15 CSV IN CLINICAL R&D

    Willi Ramseier

    Willi Ramseier, Senior Systems Validation Analyst, Hoffmann-La Roche

  • GCP vs. CSV vs. common sense - where  does one start and the other end?
  • Problems and remedies in a research laboratory which analyses clinical trial samples - practical experiences
  • Relationships between different involved groups - technicians, statisticians, research, informatics and quality
  • 10:50 Morning coffee

    11:20 IMPEMENTATION OF A RISK-MANAGED APPROACH TO COMPUTERISED SYSTEMS VALIDATION

    David Smith

    David Smith, PDQV Head of Validation Services, Hoffmann-La Roche

  • Defining a computerised system
  • Computerised Systems Risk Assessments
  • How did we do it?
  • 11:55 GAMP5 - A CSV APPROACH FOR GCP?

    Olaf Moelders

    Olaf Moelders, Portfolio Management Officer, Bayer Schering Pharma

  • Developing System Life Cycle SOPs for the clinical area 
  • Validation, change management and retirement of computerised systems 
  • Improving quality and compliance
  • 12:30 Networking lunch

    13:45 THE SYSTEM ADMINISTRATION PROCESS - A RISK-BASED APPROACH

    Rob Stephenson

    Rob Stephenson, Consultant, Elmstone Systems

  • Brief introduction to the new ISPE GAMP Good Practice Guide "A Risk-Based Approach to the Operation of GxP Computerised Systems" 
  • Case study: a scalable approach to system administration and change management 
  • The role of the System Administrator in maintaining the validated state of a system 
  • The implementation of an electronic system administration and a change management support system 
  • Benefits and lessons learned
  • 14:20 A RISK-BASED APPROACH TO A QUALIFIED INFRASTRUCTURE

    Marcelo Furlan

    Marcelo Furlan, PGXQ - Global Informatics Quality, Roche Products

  • Trends in infrastructure management and control
  • How to identify gaps in your infrastructure qualification
  • Reducing cost while staying in compliance
  • 14:55 Afternoon tea

    15:25 BRINGING EFFICIENCIES INTO A COMPUTER SYSTEMS CHANGE CONTROL

    Adil Gatrad

    Adil Gatrad, Director, Corporate Quality Computer Compliance, Watson Pharmaceuticals

  • What is change control, and what regulations govern it?
  • What are the consequences of 'non-managed' changes?
  • Which type of Quality activities are managed by computer systems?
  • What IT change management process should be in place?
  • How much testing, documentation and input from QA is appropriate to maintain the GxP state?
  • 16:00 VENDOR AUDITS AND RISK-BASED CSV

    Torben Thorhauge

    Torben Thorhauge, Life Sciences Consulting, NNIT

  • Minimising validation effort using a risk-based approach
  • Using test and requirements management tools
  • Vendor audits and the reuse of vendor specifications
  • 16:35 DOES RE-TESTING TESTED SYSTEMS ADD TO QUALITY?

    Birgit Kiene

    Birgit Kiene, Head of Computer Validation, Biopharmaceutical Department, Boehringer-Ingelheim

  • Testing of COTS / in-house developed systems
  • Management of risks: criteria for test strategy
  • Acceptance of risks: support by management
  • Quality assurance through CSV
  • 17:10 Chairman’s closing remarks and close of day one

    8:30 Re-registration & coffee

    9:00 Chairman's opening remarks

    Mark Stevens

    Mark Stevens, Managing Director, GxPi

    9:05 DEVELOPMENT AND MAINTENANCE OF IT SYSTEMS ENSURING COMPLIANCE

    Wolfgang Reh

    Wolfgang Reh, Head of Global IT Quality & Security, Roche Diagnostics

  • Keeping within frameworks of quality, security and segregation of duties
  • Including CSV in project management
  • Maintaining validated status through efficient change control
  • Conclusions from audits
  • 9:40 AUDITING GxP CRITICAL COMPUTERISED SYSTEMS

    Reinhard Voglmaier

    Reinhard Voglmaier, IT Systems Validation Manager, GlaxoSmithKline

  • Preparing for an audit - the perspective of the auditor and the auditee
  • Complying with regulators and ensuring 'inspection readiness'
  • Organising your human resources efficiently
  • 10:15 cGMP LAB AUTOMATION AND VALIDATION - OPERATIONAL EXCELLENCE IMPLICATIONS

    John Helfrich

    John Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation

  • Removing non value-added tasks from process workflow
  • Applying a high level of customisation to the business process  to match the software technology
  • Product vs. project approach - reduction in implementation time
  • 10:50 Morning coffee

    11:20 SUCCESSFUL IT SYSTEMS - STREAMLINING VALIDATION AND QUALITY

    Bob Mauger

    Bob Mauger, Principal Consultant Validation and Quality, ABB

  • SAP™/ERP, LIMS, CDS, eDMS, eCTD, TrackWise™ etc
  • Local and global implementations
  • Managing risk with real project experiences
  • 11:55 LABORATORY SYSTEM VALIDATION - STREAMLINING THE APPROACH

    Arthur Montague

    Arthur Montague, Director, Tumont

  • Hardware and software - a holistic approach 
  • Leveraging the vendor's qualification documents 
  • Lab systems configuration control
  • 12:30 Networking lunch

    13:30 DO CSV CONSULTANTS HELP OR HINDER CSV?

    Mark Stevens

    Mark Stevens, Managing Director, GxPi

  • Benefits and risks of using consultants - the role of the consultant
  • Hidden costs of using consultants - getting the correct type of support
  • Are consultants creating work for themselves?
  • 14:05 QUESTION TIME

    A chance for delegates to pose questions, suggestions, and problems to a panel of speakers taken from both days of the conference

    Reinhard Voglmaier

    Reinhard Voglmaier, IT Systems Validation Manager, GlaxoSmithKline

    Mark Stevens

    Mark Stevens, Managing Director, GxPi

    Arthur Montague

    Arthur Montague, Director, Tumont

    Wolfgang Reh

    Wolfgang Reh, Head of Global IT Quality & Security, Roche Diagnostics

    Marcelo Furlan

    Marcelo Furlan, PGXQ - Global Informatics Quality, Roche Products

    14:50 Afternoon tea

    15:20 A SENSIBLE APPROACH TO ELECTRONIC RECORDS AND SIGNATURES

    George Cahill

    George Cahill, CSV Consultant, Boehringer-Ingelheim and 4CSV

  • The good, the bad and the downright ugly systems 
  • Internet systems 
  • Archiving data
  • 15:55 MERGING COMPANIES, MERGING CSV

    Gillian Martindale

    Gillian Martindale, Director, GxP Compliance

  • CSV implications for large pharmaceutical mergers
  • Uniting CSV practice in both companies pre-merge
  • Using merger as an excuse for overhauling CSV
  • 16:30 Chairman’s closing remarks and close of day two

    +

    Workshops

    An Enterprise Compliance Management Solution for Validation of your CS
    Workshop

    An Enterprise Compliance Management Solution for Validation of your CS

    Crowne Plaza Hotel - St James
    20th April 2010
    London, United Kingdom

    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, 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.

    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@smi-online.co.uk

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