Home
overview
This Conference will explain and clarify the new regulations & guidance for computer systems, look at 21 CFR Part 11 issues and cover network infracture & systems validation. This event is especially useful for validation and IT professionals.

This event will discuss technical aspects of complying with processes and procedures, assess GAP analysis & Part 11 and tell you how to benefit from legacy systems validation. The new FDA Warning Letter process will be reviewed and the latest inspection and enforcement practices assessed. You will also hear about enforcement actions in the event that your organisation is cited for process control deficiencies. By attending this comprehensive event you will further benefit from talks about the risk-based approach to Part 11 compliance and the process and benefits of using Six Sigma for computerised systems validation.

BENEFITS OF ATTENDING:

The essential meeting on how to:
· UNDERSTAND technical aspects of complying with processes and procedures
· OPTIMISE system prioritisation - GAP analysis & Part 11 assessment
· MAXIMISE benefits of legacy systems validation
· MITIGATE enforcement actions in the event your organisation is cited for process control deficiencies
· EVALUATE the new FDA Warning Letter review process
· ASSESS the latest inspection and enforcement practices
· LEARN about the risk-based approach to Part 11 compliance
· DISCOVER the process and benefits of using Six Sigma for computerised systems validation

Gain an insight from the key industry experts in the field
· Klaus Krause, Corporate Manager, Computer Systems Compliance, Amgen
· Ron Armstrong, Manager, R&D QA, Computer Systems Compliance, Boehringer Ingelheim
· Michael Britt, Site Manager, Systems Validation Services, Roche
· Dr Robert Stephenson, Regulatory Systems Team Leader, PGMIT, Pfizer
· Dr Ludwig Huber, Product Marketing Manager, Agilent Technologies
· Dr Teri Stokes, Director, GXP International
· Kate Samways, Director, KAS Associates & Secretary, European Steering Committee (GAMP)
· Ron Johnson, Executive Vice President, Quintiles (formerly FDA)
· Carolyn Stockdale, Manager, Quality & Regulatory Compliance - Validation, Phase Forward
· Teri Stokes, Director, GXP International
· Kate Samways, Director, KAS Associates & Secretary, European Steering Committee (GAMP)
· Carolyn Stockdale, Manager, Quality & Regulatory Compliance - Validation, Phase Forward
Dr Jennifer Methfessel, Senior Consultant, Life Sciences, ABB Eutech

“Cutting edge information from multiple perspectives”
George Kuniholm, IS Compliance Manager, Vertex Pharmaceuticals, Smi Executive Briefing January 2003

Conference programme

8:30 Registration and Coffee

9:00 Chairperson’s Opening Remarks

Dr Teri Stokes

Dr Teri Stokes, Director, GXP International

9:10 KEYNOTE ADDRESS: CSV MODELS

Dr Teri Stokes

Dr Teri Stokes, Director, GXP International

  • Who does what in CSV and why?
  • What is computerised system validation (CSV) about?
  • Why have three types of qualification?
  • How is a validation plan different from a test plan?
  • What is the real reason for using summary reports?
  • 9:40 GOVERNING PROCESSES AND PROCEDURES FOR CSV

    Ron Armstrong

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

  • Corporate and global procedures
  • Local procedures
  • Practical SOPs
  • Change control
  • Fitting the needs of the business
  • 10:20 TECHNICAL ASPECTS OF COMPLYING WITH PROCESSES AND PROCEDURES

    Judi Boyle

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

  • Auditing against procedures
  • Documenting variances and justifications for deviations
  • Procedures for systems involving equipment and databases
  • 11:00 Morning Coffee

    11:20 TYPICAL DOCUMENTATION REQUIREMENTS FOR CSV

    Michael Owings

    Michael Owings, Director, Quality & Regulatory Compliance, Phase Forward

  • General validation concepts and definitions
  • Governing processes and procedures
  • The FAQs of documentation requirements
    Why is documentation required?
  • Who is responsible for documentation?
  • What should be documented?
  • How should we prepare documentation?
  • 12:00 NEW REGULATIONS AND GUIDANCE FOR COMPUTER SYSTEMS

    Dr Ludwig Huber

    Dr Ludwig Huber, Product Marketing Manager, Agilent Technologies

  • EU regulations and guidelines, eg PIC/S
  • FDA’s current thinking and implementation of part 11
  • Inspection and enforcement practices
  • Recent Warning Letters
  • Impact of risk-based system inspections
  • New focus: IT infrastructure and networked systems
    Recommendations from the industry
  • 12:40 Networking Lunch

    13:40 COMPLIANCE WITH 21 CFR PART 11

    Dr Robert Stephenson

    Dr Robert Stephenson, Regulatory Systems Team Leader, PGMIT, Pfizer

  • Clear at last? – FDA’s latest guidance on Part 11
  • A risk-based approach to Part 11 compliance
  • Part 11 – business as usual?
  • 14:20 RISK BASED PART 11 COMPLIANCE STRATEGIES

    Dr Rachita Sharma

    Dr Rachita Sharma, President, FDA Computer Validation (contracting for Bayer & Baxter)

  • Scope of Part 11 and the current FDA thinking
  • Predicate rules - the new essence
  • New & legacy systems - what is FDA saying?
  • Risk-based approach - the central point
  • GAP analysis & Part 11 assessment - system prioritisation
  • Compliance strategy - a practical approach
  • 15:00 IS 21 CFR 11 STILL THE GOLD STANDARD?

    John Farrell

    John Farrell, Principal Consultant, The Synapse Partnership

  • Traditional position of FDA as ‘strictest’ regulator
  • Strengthening European regulatory framework
  • Changes in FDA guidance and enforcement
  • Trends in European regulatory enforcement
  • Role of externally published good practice
  • 15:40 Afternoon Tea

    16:00 LEGACY SYSTEMS

    Kate Samways

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

  • Understanding the legacy system problem
  • Establishing a programme for legacy system validation
  • Benefits of doing legacy systems validation
  • Defending legacy systems during inspections
  • 16:40 PROCESSES AND TOOLS APPROACH FOR REGULATORY COMPLIANCE

    Sairamkumar Jayaraman

    Sairamkumar Jayaraman, Delivery Lead, Life Sciences Practice, Cognizant Technology Solutions

  • Regulatory challenges in life sciences IT
  • Process & tools framework for regulatory compliance
  • Case study #1 - tool-based 21CFR11 assessment
  • Case study #2 - CSV using an onsite/offshore execution model
  • CSV - critical success factors
  • 17:20 Chairperson’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    John Farrell

    John Farrell, Principal Consultant, The Synapse Partnership

    9:10 THE LATEST FDA GUIDANCE REVIEW ON PART 11 AND PROCEDURAL CHECKLISTS

    Dr Bhanu Sharma

    Dr Bhanu Sharma, Manager, Computer Systems Validation & Compliance for a leading Pharmaceutical company,

  • History of guidance document
    FDA intention vs industry reaction
  • Pure vs hybrid systems
    Current validation practices
  • Audit trail - the most confused topic
    Archival, copies of records & record retention
  • Procedural vs technical controls
  • A checklist for Part 11 success
  • Current FDA inspection trends
  • 9:40 THE FDA-483 AND THE WARNING LETTER

    Ron Johnson

    Ron Johnson, Executive Vice President, Quintiles (formerly FDA)

  • What is FDA’s foreign inspection programme?
    Can you get a Warning Letter even if you did not get a 483?
  • If no 483 is issued, should you respond to observations in the EIR?
    Who writes FDA Warning Letters?
  • Can you avoid getting a Warning Letter?
    What does the new FDA Warning Letter review process mean to you?
  • What regulatory action can result following a Warning Letter?
  • How does a Warning Letter affect a foreign company?
  • What can you do if FDA puts you on import alert?
  • 10:20 GAMP

    Holger H Reusch

    Holger H Reusch, Computer Systems Validation Specialist, Integrity Solutions

  • Influence of different risks on your computer validation programme
  • When and how to evaluate risk throughout the lifecycle
  • Expectations for validation of different types of application (eg LIMS, custom development, spreadsheets)
  • Using GAMP to validate your computerised system
  • 11:00 Morning Coffee

    11:20 APPLICABILITY OF SOPS TO IT DEPARTMENTS

    David Stephenson

    David Stephenson, Principal Computer Systems Validation Specialist, Aker Kvaerner

  • What is achieved by SOPs?
  • What are they written for?
  • How does this affect the IT team?
  • Existing technical activities are performed accordingly
  • 12:00 QUALIFICATION OF NETWORK INFRASTRUCTURE AND SYSTEMS VALIDATION

    Michael Britt

    Michael Britt, Site Manager, Systems Validation Services, Roche

  • Definitions – the 4 Qs
  • How does infrastructure align with the business model?
  • The elements of infrastructure
  • Qualification vs validation
  • Steps to qualification of infrastructure
  • Supporting your customers/users validation needs
  • 12:40 Networking Lunch

    13:40 SECURING YOUR NETWORK

    John Dickson

    John Dickson, Senior Consultant, Thermo Electron

  • Who owns the network? – get it under control
  • Remember 85% of attacks are from inside your company
  • Secure GXP data with at least a router and firewall
  • Use all the security features of the operating system
  • Explain very clearly to staff the reasons for network security and then act on security breaches
  • Data is the beginning of corporate intellectual property – guard it well
  • 14:20 QUALITY MANAGEMENT SYSTEM FOR COMPUTER SYSTEMS COMPLIANCE

    Klaus Krause

    Klaus Krause, Corporate Manager, Computer Systems Compliance, Amgen

  • System structure
  • Components and controls
  • Global computer system registry as a quality management tool
  • 15:00 EFFECTIVE GAP ANALYSIS AS A TOOL FOR COMPLIANCE

    Dr Jennifer Methfessel

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

  • Effective GAP analysis techniques
  • Preparing for a GAP analysis: developing worksheets and checklists
  • Conducting a computer systems GAP analysis
  • Conducting a 21 CFR Part 11 GAP analysis
  • Risk analysis techniques
  • Practical and impractical corrective methods
    How to mitigate enforcement actions in the event your organisation is cited for deficiencies
  • 15:40 Afternoon Tea

    16:00 TOOLS AND CONCEPTS OF SIX SIGMA

    Dr Radouane Oudrhiri

    Dr Radouane Oudrhiri, Chief Technology Officer, Systonomy
    View Bio

  • The economics of computerised systems compliance and validation
  • How Six Sigma and software process improvement fit into quality regulation systems
  • What Six Sigma tools are usable in computerised system validation and how process improvement methodologies operate
  • The use of measurement to prove objective success and achievement
  • Challenges for deploying such initiatives within software/IT communities
  • 16:40 GETTING THE MOST OUT OF YOUR SUPPLIER

    Dr David James

    Dr David James, Principal Engineer, Invensys Systems

    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
    19th November 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.