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This conference will provide a forum for Validation and IT/IS Professionals to hear from other specialists about the technical implementation of legislation governing the validation of computer systems in the Pharmaceutical Industry and share their knowledge of controversial issues and real problems.

Hear from leading industry experts including:

  • Dr Guy Wingate, Director, Global Computer Validation, GlaxoSmithKline, Global Manufacturing & Supply
  • Pranay Butala, Head, Global Quality, AIS, Aventis
  • Norbert Fritz, Head, Clinical Programming, F. Hoffman-La Roche
  • Judi Boyle, Associate Director, R&D QA, External GMP & Part 11 Computer Validation Compliance, Boehringer-Ingelheim
  • Karin Östergren, Associate Director, QA Computerised Systems, AstraZeneca
  • Olaf Mölders, Global IT/IS Validation Manager, Bayer Healthcare
  • Hani Kamel, Quality & Security Advisor, Novo Nordisk
  • Richard Fazackerley, QA Validation Team Leader, Eli Lilly
  • Susan Widlake, Computer Compliance Specialist, Amgen

The essential event on:

  • VALIDATION & COMPLIANCE: Hear about business systems validation and FDA compliance for 21 CFR Part 11
  • RISK BASED APPROACHES: Understand the current issues surrounding laboratory systems and information systems
  • CLINICAL STUDY DATABASES: Gain an insight into how risk assessment can help to find the most suitable validation approach
  • PLANNING & SCRIPT WRITING: Assess validation planning for success as well as risk and impact analysis
  • NETWORK WITH KEY EXPERTS: Make valuable contacts with those at the forefront of development and implementation

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Susan Widlake

Susan Widlake, Computer Compliance Specialist, Amgen

9:10 BUSINESS SYSTEMS VALIDATION AND FDA COMPLIANCE FOR PART 11

Dr Bhanu Sharma

Dr Bhanu Sharma, Supervisor, Business Systems Validation, Bayer

  • Validation overview
  • The compliance element
  • FDA perspective
  • Why risk-based?
  • 21st century GMP
  • 9:50 A RISK BASED APPROACH TO ELECTRONIC RECORDS AND SIGNATURES

    Dr Guy Wingate

    Dr Guy Wingate, Director, Global Computer Validation, GlaxoSmithKline

  • Global perspective on regulatory expectations
  • Managing the transition to new FDA expectations for Part 11
  • Understanding risk, impact and criticality
  • Establishing efficient and effective practices
  • Review of current industry initiatives
  • 10:30 Morning Coffee

    11:00 A CASE STUDY

  • Defining a validation program for laboratory computers
  • Utilising FMEA
  • Risk assessment documentation
  • Risk evaluation for unresolved test case failures
  • Judi Boyle

    Judi Boyle, Associate Director, R&D QA, External GMP & Part 11 Computer Validation Compliance, Boehringer-Ingelheim

    Mrs Judi Boyle

    Mrs Judi Boyle, Associate Director, Boehringer Ingelheim

    11:40 RISK-BASED APPROACH FOR INFORMATION SYSTEMS

    Michelle Whitehead

    Michelle Whitehead, Senior Validation Engineer, Schering Plough

  • Objectives of the risk-based approach
  • Classification process for information systems
  • Examples of approaches - including validation strategies and document content
  • 12:20 Networking Lunch

    13:50 PANEL DISCUSSION: THE RISK-BASED APPROACH

    Pranay Butala

    Pranay Butala, Head, Global Quality, AIS, Aventis

    Hani Kamel

    Hani Kamel, Quality and Security Advisor, Novo Nordisk

    Richard Fazackerley

    Richard Fazackerley, QA Validation Team Leader, Eli Lilly & Company

    Michelle Whitehead

    Michelle Whitehead, Senior Validation Engineer, Schering Plough

    14:30 QUALIFICATION APPROACH FOR IT-INFRASTRUCTURE IN A GLP/GCP ENVIRONMENT

    Olaf  Mölders

    Olaf Mölders, Global IT/IS Validation Manager, Bayer Healthcare

  • Qualification planning - validation master plan, SOP’s
  • Data centres
  • Networks for buildings
  • Backbone
  • Documentation
  • 15:10 Afternoon Tea

    15:40 SCALABILTY - COMPUTER SYSTEM VALIDATION

    Ramkumar  Rayapureddy

    Ramkumar Rayapureddy, Manager, Computer Systems Validation & Automation Integration, Global Technical Services, Schering Plough

  • How to determine complexity of system
  • Validation strategy based on system complexity and risk
  • Multi-site implementation of similar systems
  • 16:20 EFFECTIVE VALIDATION OF COMPLEX SYSTEMS

    Karin Ostergren

    Karin Ostergren, Associate Director, QA Computerised Systems, AstraZeneca

  • Roles and responsibilities
  • Validation planning
  • Modular qualification
  • SOP’s and service agreements
  • Prepare for maintenance
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re - registration & Coffee

    9:00 Chairperson's Opening Remarks

    Judi Boyle

    Judi Boyle, Associate Director, R&D QA, External GMP & Part 11 Computer Validation Compliance, Boehringer-Ingelheim

    Ron Armstrong

    Ron Armstrong, Manager, R&D QA, Computer Systems Compliance, Boehringer Ingelheim

    9:10 A RISK-BASED APPROACH TO COMPUTER SYSTEMS AUDITS AND EVALUATIONS

    Susan Widlake

    Susan Widlake, Computer Compliance Specialist, Amgen

  • The main topics for computer compliance auditing
  • Developing a framework for audit areas
  • Using risk assessment as an audit tool
  • 9:50 VALIDATION OF CLINICAL STUDY DATABASES AND RELATED COMPUTERIZED PROGRAMS

    Norbert Fritz

    Norbert Fritz, Head, Clinical Programming, F. Hoffman-La Roche

  • How does validation of study databases tie into computer system validation
  • How risk assessment can help to find the most suitable validation approach
  • Standardization of database objects: can it help?
  • 10:30 Morning Coffee

    11:00 TAMING YOUR INFRASTRUCTURE JUNGLE

    Dr Jennifer Methfessel

    Dr Jennifer Methfessel, Senior Consultant, ABB Process Solutions

  • Why you might be concerned about your infrastructure
  • The value of risk analysis
  • The first step to taming your infrastructure - network diagrams
  • Knowing where your servers are and what they are doing
  • Finding a win-win situation for compliance and operations
  • Keeping things under control long term
  • 11:40 VALIDATION PLANNING AND SCRIPT WRITING

    Richard Fazackerley

    Richard Fazackerley, QA Validation Team Leader, Eli Lilly & Company

  • Validation planning for success
  • Validation testing and deliverables for lifecycle management
  • Risk and impact analysis
  • Addressing the business needs and requirements for the system
  • 12:20 Networking Lunch

    13:50 VALIDATION AND QUALIFICATION FOR SYSTEMS

    Pranay Butala

    Pranay Butala, Head, Global Quality, AIS, Aventis

  • Validation planning - what items need to be covered?
  • Requirements planning - how much is enough?
  • Testing - what should be done?
  • Procedures - which ones, and why?
  • Operations - how do I keep my system in a validated state?
  • 14:30 KEEPING UP TO DATE

    Robert Stephenson

    Robert Stephenson, Regulatory Systems Team Leader, PGMIT, Pfizer

  • Where and why does it all go wrong?
  • Maintaining the systems inventory and the master validation plan
  • Key tools - change control and periodic review
  • Recovery from systems failure
  • 15:10 Afternoon Tea

    15:40 VALIDATION OF COMPUTER SYSTEMS USED IN CLINICAL TRIALS

    Hani Kamel

    Hani Kamel, Quality and Security Advisor, Novo Nordisk

  • Laws and regulations in the GCP area
  • Computer systems in clinical trials
  • Validation concepts for computer systems
  • Planning the validation process - pre-validation activities
  • Documenting the validation process - validation activities
  • Maintaining the validation state - post validation activities
  • Practice and experience
  • Discussions and conclusions
  • 16:20 MANAGING THE SCOPE OF COMPLIANCE NEEDS

    Ian Storr

    Ian Storr, Managing Consultant, PA Consulting Group

  • Meeting requirements for computer system compliance with regulations focusing on provability and traceability of data already means that a significant burden is being placed on the systems supporting ‘quality critical’ processes
  • With increased automated, computerised support for quality processes, it is the systems and the way in which they have been controlled that are scrutinised during inspections rather than the processes themselves
  • Ensuring an appropriate level of compliance for all existing and new systems supporting these processes already presents resource, pace of change and compliance standards challenges for many organisations
  • Additional regulations (such as HIPPA, Sarbanes Oxley and those relating to legal weight of evidence supporting patent protection and litigation) are now requiring similar controls to be applied outside of the normal ‘quality critical’ process domain will add to this challenge
  • This session explores how organisations now need to be looking systems supporting processes being effected by current and emerging legislation and regulation and how a risk based approach can be used to secure an appropriate degree of compliance based on a pragmatic, risk based approach looking systems supporting processes being effected by current and emerging legislation and regulation and how a risk based approach can be used to secure an appropriate degree of compliance based on a pragmatic, risk based approach
  • 17:00 Chairperson’s Closing Remarks and Close of Conference

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    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

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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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