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This conference will provide a forum for RA/QA Professionals, Laboratory Managers and Users to learn about the validation of computerised systems and how this can be integrated into business operations.

The conference will explain and clarify the current regulations that guide validation of laboratory computer systems, including 21 CFR Part 11 compliance issues. The event will focus on how to develop and successfully implement validation plans, providing practical information backed up by specific case studies illustrating companies’ experiences of the validation processes, from installation to operation and ongoing performance.

This comprehensive event will provide clear, practical information on topics including how to write SOPs, how to implement the procedures, how to audit the processes and the ins and outs of electronic signatures, system security and data archiving, allowing the development of efficient, cost-effective and achievable validation procedures.

Hear from experienced professionals what the implications of CSV are for your company in 2003
· Hani Kamel, Quality & Security Advisor, Novo Nordisk
· Richard Thomas, Validation Manager, Amersham Health
· Karin Östergren, Manager, Quality System Computerised System & Validation, AstraZeneca

A comprehensive event where you learn about
· COMPUTER SYSTEM VALIDATION: what is it all about & what does it mean to your company?
· THE FDA REGULATIONS & REQUIREMENTS: get a comprehensive breakdown of the latest regulations straight from the FDA
· 21 CFR PART 11: practical guidelines for implementation & compliance
· ELECTRONIC RECORDS: learn about existing standards and guidelines
· REQUIREMENTS FOR USE OF SPREADSHEETS: what is important for calculation integrity?

Conference programme

8:30 Registration and Coffee

9:00 Chairperson’s Opening Remarks

Paul Coombes

Paul Coombes, Head of CSV and LSV (Eastern Hemisphere) , Washington Group
View Bio

9:10 WHAT IS COMPUTER SYSTEMS VALIDATION?

Bob Taylor

Bob Taylor, Technical Director, Smart Tech Worldwide (formerly GlaxoSmithKline)

  • Use a recognised standard approach to project management, software development and validation
  • Get close to system suppliers
  • Reduce the number of system suppliers
  • Leverage existing information
  • Aim to reduce costs without compromising quality
  • Use software to track the validation lifecycle
  • 9:40 AN INTRODUCTION TO 21 CFR PART 11 AND ITS COMPLIANCE

    Richard Thomas

    Richard Thomas, Validation Manager, Amersham Health

  • What is 21 CFR Part 11 and why do we have it?
  • Key elements of the rule
  • What are the compliance issues?
  • How does Part 11 impact business process?
  • FDA’s current thinking and approach
  • 10:20 A PRACTICAL APPROACH TO THE IMPLEMENTATION OF CFR PART 11

    Karin Östergren

    Karin Östergren, Manager, Quality System Computerised System & Validation, AstraZeneca

  • Recognising the importance of training management and lab supervisors
  • Building a strategy for inventory collection
  • Evaluating methods for GAP analysis and scheduling
  • Analysing system and remediation prioritisation
  • Developing immediate measures towards compliance
  • Investigating longer terms solutions
  • 11:00 Morning Coffee

    11:20 WHAT IS A NETWORK?

    Arthur Charlesworth

    Arthur Charlesworth, Validation Consultant, ABB Eutech (formerly GlaxoSmithKline)

  • Infrastructure qualification
  • Validation vs qualification
  • Why application validation includes ‘the network’?
  • Drivers for qualifying your network
  • 12:00 CASE STUDY

    Paul Coombes

    Paul Coombes, Head of CSV and LSV (Eastern Hemisphere) , Washington Group
    View Bio

    12:40 Networking Lunch

    14:00 AUDITING SYSTEMS SECURITY PROCESSES

    Hani Kamel

    Hani Kamel, Quality & Security Advisor, Novo Nordisk

  • Primary site visit and conducting an audit
  • Conducting the audit
  • Deciding when and what type of audit to conduct
  • Corrective action
  • Critical documentation for computerised systems
  • How do you determine if the system has been developed correctly and still functions well?
  • 14:40 LIFECYCLE APPROACH TO THE VALIDATION OF COMPUTERISED SYSTEMS

    Marian Mutch

    Marian Mutch, QA Staff Associate, System Validation, Europe, Covance Laboratories

  • Strategy and methodologies for the validation of computerised systems
  • Benefits of adopting a lifecycle approach
  • Importance of the validation documentation generated
  • Significance of a validation team to successful validation and implementation
  • Importance of team management and communication during the validation
  • 15:20 INSTALLATION, OPERATIONAL, PERFORMANCE QUALIFICATIONS

    Dr Brian Hatton

    Dr Brian Hatton, Consultant, Pharmaceutical Division, Bovis Lend Lease

  • Verifying the equipment is installed according to manufacturer’s recommendations
  • Operating conditions, physical connections, system configuration
  • Ensuring the equipment operates as intended by manufacturer
  • What are the pre-defined acceptance criteria derived from the operational specifications?
  • Suitability for use: the final area of qualification testing
  • 16:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Chris Montgomery

    Chris Montgomery, IT Regulatory Manager, Celltech

    9:10 CASE STUDY

    Dr James Stafford

    Dr James Stafford, Senior Consultant, Mi Services

  • What types of laboratory systems and equipment require validation vs traditional qualification approaches?
  • Is validation limited to software applications and systems?
  • How does it apply to microprocessor based equipment?
  • How does Part 11 and other regulations and guidance impact this decision?
  • 9:40 VALIDATION OF EXISTING SYSTEMS

    Bob Taylor

    Bob Taylor, Technical Director, Smart Tech Worldwide (formerly GlaxoSmithKline)

  • What is a scaleable system?
  • Assessing the scope of the validation exercise
  • Becoming effective - applying risk based approaches to validation of a scaleable system
  • Becoming efficient – approaches to a lean validation
  • Change control and scaleability
  • Examples of validating scaleable systems – an enterprise chromatographic data system and a scaleable LIMS system
  • 10:20 VALIDATION OF A LIMS FOR CLINICAL ASSAYS

    Chris Montgomery

    Chris Montgomery, IT Regulatory Manager, Celltech

  • How is a quality plan established?
  • What is the process for vendor selection?
  • What are the objectives of the vendor audit?
  • How are the user requirements gathered and documented?
  • How is the validation plan created?
  • What steps are required to complete the validation process?
  • 11:00 Morning Coffee

    11:20 EXCEL – HEAVEN OR HELL

    Dr Christopher Burgess

    Dr Christopher Burgess, Principal, Burgess Consultancy

  • It is only a printing calculator isn’t it?
  • Regulatory requirements for calculation integrity
  • System development lifecycle for spreadsheets
  • Validation and verification
  • GAMP 4
  • Part 11 and all that
    Data migration and change control
  • 12:00 CASE STUDY

    Wayne Ziegler

    Wayne Ziegler, Director, Computer & Automation Validation, Worldwide Technical Services, Schering-Plough

  • Learn what cGMP and 21 CFR Part 11 require for spreadsheet use
  • Inspectional observations and FDA expectations
  • Learn which documents are expected for national and international environments
  • Learn how to implement a practical spreadsheet validation program
  • Learn how to define, code and manage your spreadsheets to promote integrity of data
  • Qualification of the environment to define compliant use
  • 12:40 Networking Lunch

    14:00 RISK ANALYSIS: WHAT DOES IT MEAN FOR 21 CFR PART 11 COMPLIANCE?

    Victoria Lander

    Victoria Lander, Market Development Manager, NuGenesis Technologies

  • What has recently changed with regard to the new FDA approach to 21 CFR Part 11?
  • Discussion of the new FDA Draft Guidance Document for Part 11 interpretation
  • What is a ‘risk-based’ approach to Part 11?
  • Why do a risk assessment?
  • What are the commonly accepted risk management approaches?
  • How to apply HACCP, FMEA and FMECA to risk assessment for Part 11
    Moving forward with your Part 11 remediation plan
  • 14:40 SCIENTIFIC DATA, DIGITAL ARCHIVES, THE GRID AND PHARMACEUTICAL INDUSTRY REGULATIONS

    Alison Macdonald

    Alison Macdonald, Senior Consultant, The Digital Archiving Consultancy

  • Brief history of e-records regulations in the pharmaceutical industry, current FDA position
  • The non-regulatory drivers behind data archiving
  • What is an electronic record?
  • Why scientific data represent a particular and growing challenge
  • The lab, the grid and electronic records
  • Existing standards and guidelines
    Sample projects illustrating key issues in scientific data archiving
  • 15:20 Chairman's Closing Remarks Followed by Afternoon Tea.
    Close of Conference

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    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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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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