Home
overview
Industry is becoming increasingly dependent on computerised systems and the healthcare industry is no exception. With the rapid technological advancement in this sector, there is a requirement for evaluation and validation of existing IT systems and for out-dated systems to be phased out and replaced by those with improved performance and reliability. The quality of electronic systems for laboratory and clinical use is carefully regulated and there is a need to gain a greater understanding of what if required by the regulatory bodies such as the FDA and GMP.

This conference will aim to take on the challenge to today’s healthcare industry, to develop practical solutions for integrating the quality assurance of computerised systems and electronic data into everyday business operations. The conference will bring together information directors, software project managers, application users, IT/IS installing teams and quality assurance professionals in the pharmaceutical and biotech industries. Presentations and discussions will assess current problems in computer validation and put forward possible solutions to allow for the successful integration of IT and life sciences in 2003 and beyond.

Previous attendees Pfizer AstraZeneca Novo Nordisk Ipsen International Amgen Berlex Laboratories Celltech Siemens Schering Steripak PricewaterhouseCoopers Eutech Engineering Solutions Investec Asset Management Q-One Biotech Limited Oxford Asymmetry International CB Technologies

Key issues include Establishing clear and unambiguous requirements GAMP 4 guidelines Improving understanding of the requirements of 21 CFR Part 11 Practical implementation of 21 CFT Part 11 at the user site Preparing for computer system audits Improving communications between supplier and client Validating legacy systems The roles and responsibilities of OQ,IT dept, IQ and PQ Assessing the impact of software changes Process excellence in validation life cycle Increasing efficiency of software validation Back up and securing of data and applications The role of cryptography in securing electronic data Electronic devices and computerised systems in clinical trials

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Christopher Evans

Christopher Evans, Manager, Site Audit & Compliance Support, GlaxoSmithKline

9:10 MOVING TOWARDS A PAPERLESS ENVIRONMENT?

  • What is the ultimate aim of computer systems in the pharmaceutical industry?
  • A look at how computational technologies transform life sciences across a range of disciplines
  • Integrating computer systems with healthcare research practices
  • The importance of validation of computer systems for the smooth running of your business
  • Achieving the goals set for computer validation: the key to successful implementation
  • The future of IT validation: room for improvement
  • Angela Winter

    Angela Winter, Computer System Validation Specialist, Validation Technologies

    Angela Winter

    Angela Winter, Computer System Validation Specialist, Validation Technologies

    9:40 OVERVIEW OF COMPUTER SYSTEMS VALIDATION

    Dr Bhanu Sharma

    Dr Bhanu Sharma, Manager, Computer Systems Validation & Compliance, Bayer

  • Why to validate: an overview of current regulatory requirements

    Writing a validation master plan

  • IQ, OQ, PQ execution and validation summary report

    Compliance strategy

  • New systems vs legacy systems

    Risk assessment

  • 21 CFR Part 11 assessment
  • Procedural and technical controls for remediation
  • Meeting the regulations
  • 10:20 THE GATEWAY TO QUALITY AND COMPLIANCE: ESTABLISHING CLEAR AND UNAMBIGUOUS REQUIREMENTS

    Dr Radouane Oudrhiri

    Dr Radouane Oudrhiri, Chief Technology Officer, Systonomy

  • What are requirements and why are requirements important? Why is the requirement engineering process so difficult?

    Understanding the impact of requirements on business risk

  • Consideration and integration of regulatory requirements

    Identifying the stakeholders and their interests

  • Introduction to requirements engineering process
  • Using the multiplicity of requirement styles and elicitation techniques as a means to mitigate risks and reduce ambiguity
  • Requirements verification and validation
  • Managing requirements change and traceability
  • 11:00 Morning Coffee

    11:20 GAMP 4 GUIDELINES

    Christopher Evans

    Christopher Evans, Manager, Site Audit & Compliance Support, GlaxoSmithKline

  • Widely used and internationally accepted guidelines: good practice definitions
  • The need to bring the guidelines up to date to reflect current regulatory expectations and good practice
  • What are the benefits of the new version?
  • Applying GAMP 4 to determine the extent and scope of validation for different types of automated system
  • Validation life cycle
  • Ensuring the automated system remains in a validated state
  • 12:00 21 CFR PART 11: IMPROVING UNDERSTANDING OF THE REQUIREMENTS

    David Rai

    David Rai, Healthcare Division, Tescom

  • Details to be announced
  • 12:40 Lunch

    13:40 AN INSPECTOR CALLS

    John Farrell

    John Farrell, Principal Consultant, The Synapse Partnership

  • Based on a wide range of real inspections
  • What are the hot points?
  • What are the emerging areas of interest?
  • What are the underlying trends?
  • 14:20 COMPUTER SYSTEM AUDITS: PREPARE, PREPARE, PREPARE

    Sharon Strause

    Sharon Strause, Senior IM Consultant, Computer System Validation, McNeil Consumer & Speciality Pharmaceuticals, Johnson & Johnson

  • Gain an understanding of what needs to be done to prepare for a site audit
  • Guidelines for an internal audit programme and preparation team
  • Maximise the audit process for internal process improvement in your company
  • Standardise your company’s audit process
  • 15:00 IMPROVING COMMUNICATIONS BETWEEN SUPPLIER AND CLIENT

  • How do we communicate?
  • Common communication issues seen at audit - between sponsors - between sponsors and suppliers
  • Techniques for ensuring good communications
  • Ensuring effective audits via good communication of requirements
  • Karen Hue

    Karen Hue, Director, ADAMAS Consulting

    Neil Konopka

    Neil Konopka, Head, International Quality & Regulatory Compliance, Phase Forward Europe

    15:40 Afternoon Tea

    16:00 VALIDATING LEGACY SYSTEMS

    Kate Samways

    Kate Samways, Director / Secretary, KAS Associates / European Steering Committee (GAMP)

  • Typical issues with legacy systems
  • Use of gap and risk analysis
  • Updating the dynamic documentation
  • Filling the gaps
  • Remaining in control
  • 16:40 A PRACTICAL APPROACH TO COMPUTER SYSTEMS VALIDATION SERVICES

    Brigitte Staecker

    Brigitte Staecker, Validation Consultant, ThermoLabsystems

  • Validation: a project in a project?
  • What can a validation consultant offer?
  • The importance of planning and process
  • Documentation development, challenges and pitfalls
  • Performing the testing: the proof of the pudding?
  • Supporting validation and compliance
  • 17:20 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Sharon Strause

    Sharon Strause, Senior IM Consultant, Computer System Validation, McNeil Consumer & Speciality Pharmaceuticals, Johnson & Johnson

    9:10 OQ, IQ, PQ: WHAT ARE THE ROLES AND RESPONSIBILITIES FOR SOFTWARE SUPPLIER (OQ), IT/IS DEPT (IQ) AND END USER GROUP (PQ) IN COMPUTERISED SYSTEM VALIDATION (CSV)?

    Dr Teri Stokes

    Dr Teri Stokes, Director, GXP International

  • Validation of computerised systems to GCP/GLP/GMP compliance is a senior management responsibility
  • Management commitment is essential and active oversight and control are required for compliant OQ/IQ/PQ
  • Software supplier, platform supplier and application user each have a significant, ongoing role to play
  • Quality management systems (QMS) must define and support validation work at each stage of system life as an integrated part of business operations activities
  • Standard policy, procedures, packages and templates give a common sense approach to validation in the context of business and regulatory priorities and concerns for each stage of a system’s life
  • Validation documentation allows management, auditors and inspectors to give credit for good work performed to ensure the management control, system reliability and data integrity of computerised systems
  • 9:40 COMPUTER SYSTEM/AUTOMATED SYSTEM VALIDATION

    Marin Klaric

    Marin Klaric, Business Development Specialist, Pliva

  • Linkage between different islands of terminology, knowledge, experiences and views: design, user, control system vendor, package unit vendor, quality assurance
  • Different start time of URS for automated system and URS for computer system
  • Drivers to timely and cost effective commissioning and qualification, coming from ISPE C&Q guide
  • Parallel and sequential activities
  • Off-site/on-site implementation/inspection/testing: overall scope, integration and repetitions
  • Integrated business and manufacturing processes: what to commission? What to qualify/validate?
  • 10:20 ASSESSING THE IMPACT OF SOFTWARE CHANGES

    Dr Jennifer Methfessel

    Dr Jennifer Methfessel, Senior Consultant, Life Sciences, ABB Eutech

  • Is there a conflict of interest between the software industry and the pharmaceutical industry?
  • What are the drivers for software upgrades?
  • Understanding the design specifications of new software: what can it do for you?
  • Writing a project and validation plan based on specifications

    Keeping track of changes to operating system software

  • Documenting and managing the changes

    Controlling the cost of validating new software

  • Long term archiving of data to prevent problems with changing software
  • 11:00 Morning Coffee

    11:20 LONG-TERM ARCHIVING OF ELECTRONIC RECORDS

    Alison Macdonald

    Alison Macdonald, Senior Consultant, The Digital Archiving Consultancy

  • What is an electronic record?
  • Standards and guidelines
  • Stakeholders and benefits
  • What do you need to keep?
  • The importance of process
  • Migration, emulation, time capsules: technical difficulties
    Validation considerations
  • 12:00 INCREASING THE EFFICIENCY OF SOFTWARE VALIDATION

    Dr Brian Davies

    Dr Brian Davies, Technology Manager, PerkinElmer

  • What are testing automation tools?
  • How do they work?
  • Reducing costs and increasing quality of the testing/validation process
  • What role can automation tools play in vendor organisations?
  • What role can automation play in the pharmaceutical validation process?
  • Examples from the development of laboratory instrumentation software systems
  • 12:40 Lunch

    13:40 BACK UP AND SECURING OF DATA AND APPLICATIONS

    George Kuniholm

    George Kuniholm, IS Compliance Manager, Vertex Pharmaceuticals

  • Backup, contingency planning and archiving requirements
  • Establishing service level agreements within your organisation
  • Overview of backup methods and data/application availability
  • Creating and communicating a viable contingency plan
  • Meeting archiving requirements and long term storage methods
  • Creating SOPs and verifying data security
  • 14:20 THE ROLE OF CRYPTOGRAPHY IN SECURING ELECTRONIC DATA

    Daniel Murton

    Daniel Murton, International Marketing Director, nCipher

  • Introduction to cryptography and digital signatures: 21CFR Part 11 and beyond
  • Generating and using effective digital signatures
  • Transporting data securely: the role of SSL
  • Securing stored data: protecting the crown jewels
  • Proving the point: time stamps and audit trails
  • Deploying secure cryptographic hardware
  • 15:00 DESIGN, IMPLEMENTATION AND VALIDATION OF ELECTRONIC BATCH RECORD SYSTEMS

    Justin Iovino

    Justin Iovino, Director, Business Development, CimQuest

  • History of batch records and the evolution of technology
  • Current industry conditions driving EBRS
  • System architecture and the validation impact
  • Content and controls required in an EBRS
  • Criteria for record archival, retrieval and retention
  • Benefits of implementing an EBRS
  • 15:40 Afternoon Tea

    16:00 ELECTRONIC DEVICES IN CLINICAL TRIALS

  • Why do we use devices?
  • Understanding the validation environment
  • The importance of risk analysis
  • The future solutions
  • Andy Lawton

    Andy Lawton, Head, Biometrics & Data Management, Boehringer Ingelheim

    Angela Winter

    Angela Winter, Computer System Validation Specialist, Validation Technologies

    Angela Winter

    Angela Winter, Computer System Validation Specialist, Validation Technologies

    16:40 COMPUTERISED SYSTEMS IN CLINICAL TRIALS

    Dr Jean Paty

    Dr Jean Paty, Chief Quality Officer, Invivodata

  • Using an electronic diary system to create, modify, maintain, archive, retrieve and transmit clinical data
  • Subjecting the diary solution to a vigorous validation policy
  • Entering original observations directly into a computerised system: accurate reflection of patient experience
  • Using the internet to transfer data and uploading data nightly to improve effective trial management
  • Identifying the right technical solution for Phase I, II, III and IV clinical trials
  • 17:20 Chairman's Closing Remarks and Close of Conference

    +

    Workshops

    Technical Aspects of Implementing 21 CFR Part 11
    Workshop

    Technical Aspects of Implementing 21 CFR Part 11

    The Hatton, at etc. venues
    29th January 2003
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.