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This conference will provide attendees with the latest developments in Computer Systems Validation. There will be an outline of the future trends and innovations in the market. Close attention will be given to FDA standards and how these requirements effect the development of validation systems.

There will be an overview of the current 'hot' issues effecting the industry. These include outsourcing and governance and strategy- are these the next stage for businesses to consider?

An opportunity to listen to presentations from major companies discuss the technical implementation of the legislation governing the validation of computer systems. Listen as they share their knowledge of controversial issues and real problems.

SMi’s 6th Conference on ‘Computer Systems Validation’ seeks to provide a forum for leading industry experts from major companies to discuss and evaluate the latest challenges and problems facing the market. The conference will provide attendees with an excellent opportunity to network, enhance your company’s profile and keep up-to-date on the latest issues in the Computer Systems Validation market

This years speakers include:

  • Dr Guy Wingate, Director, Strategy, Systems & Knowledge Management, Global Manufacturing & Supply, GlaxoSmithKline
  • Dr Siegfried Schmitt, Quality Director, GE Healthcare
  • Ramkumar Rayapureddy, Director, Automation Integration & Computer Systems Validation, Schering-Plough
  • Karin Ostergren, Associate Director, QA Computerised Systems, Quality Assurance, AstraZeneca
  • Dr Bhanu Sharma, Global Quality, Validation & Documentation, Bayer Healthcare
  • Michelle Whitehead Lemasters, Technical Manager, Schering-Plough
  • Dr Peter Bosshard, Quality Manager, F. Hoffmann – La Roche
  • Morten Urhoej Palm, Manager & Senior Consultant, NNIT A/S
  • Earl Hulihan, Senior Vice President, Regulatory Consulting, META Solutions

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michelle Whitehead Lemasters

Michelle Whitehead Lemasters, Technical Manager, Schering Plough

9:10 RISK MANAGEMENT PRINCIPLES FOR COMPUTERISED SYSTEMS

John Andrews

John Andrews, Director, Andrews Consulting Enterprises Ltd

9:50 RISK-BASED COMPUTER SYSTEMS VALIDATION

Ian Storr

Ian Storr, Managing Consultant, PA Consulting Group

  • Identifying and managing potential threats to keep systems free from compliance risk
  • Quantifying the effect of the threat on your systems and gauging your response
  • Appropriately applying technologies to ensure consistent security management of critical systems
  • Ensuring the availability and dependability of critical systems
  • How to make sure that your response to validation is measured, robust and remains practical, achievable and adds value
  • 10:30 Morning Coffee

    11:00 A RISK-BASED APPROACH TO VALIDATING NETWORKS

  • How to justify and document these approaches
  • Evaluating existing networks
  • Assessing the risk posed by the network- low, medium or high?
  • The reality of a risk-based approach for companies
  • Ramkumar Rayapureddy

    Ramkumar Rayapureddy, Director, Automation Integration & Computer Systems Validation, Schering Plough

    11:40 A RISK-BASED APPROACH TO QUALIFIED INFRASTRUCTURE

    Morten Urhoej Palm

    Morten Urhoej Palm, Manager & Senior Consultant, NNIT A/S

  • How to identify gaps in your infrastructure qualification
  • New GAMP good practice guidelines for infrastructure qualification
  • Roadmaps and best practices to a qualified infrastructure
  • A horizontal approach to qualification- the building block concept
  • Reducing the cost while staying in compliance
  • Ensuring a risk-based approach
  • 12:20 Networking Lunch

    14:00 PANEL DISCUSSION

  • What are the various methods involved?
  • Who gets involved?
  • What standards need to be followed?
  • How are these methodologies structured?
  • Siegfried Schmitt

    Siegfried Schmitt, Quality Director, GE Healthcare

    Dee Carri

    Dee Carri, Founder & Director, Torque Management

    Michelle Whitehead Lemasters

    Michelle Whitehead Lemasters, Technical Manager, Schering Plough

    14:40 MAINTAINING QUALITY IN AN OUTSOURCED ENVIRONMENT

    Chris Reid

    Chris Reid, Director and Principal Consultant, Integrity Solutions

  • Outsourcing life cycle from a QA perspective
  • Benefits and risks associated with outsourcing
  • Issues to be managed and points to consider
  • Considerations: people, cultures, systems, processes, information, access
  • Accountabilities and relationships
  • Managing improvement as well as maintaining the status quo
  • 15:20 KEY INFORMATION STRATEGIES FOR THE VALIDATION OF LABORATORY INFORMATION MANAGEMENT SYSTEMS (LIMS)

  • Practical strategies to develop a validation master plan, validating existing systems and prepare for inspections
  • Change management strategies of existing and upgraded systems, validation of hardware and software and revalidation
  • Risk considerations- the LIMS system
  • Compliance of data management within the RD and QC laboratory- its relevance to CFR Part 11
  • Cost-effective ways to upgrade your knowledge in validation and regulatory requirements for LIMS
  • Michelle Whitehead Lemasters

    Michelle Whitehead Lemasters, Technical Manager, Schering Plough

    16:00 Chairperson's Closing Remarks Followed by Afternoon Tea, Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Siegfried Schmitt

    Siegfried Schmitt, Quality Director, GE Healthcare

    9:10 IT COMPLIANCE, GOVERNANCE AND STRATEGY

    Dee Carri

    Dee Carri, Founder & Director, Torque Management

  • The growing IT compliance agenda
  • Integrated compliance challenges: SOX, GXP, Privacy
  • Emerging governance models
  • Roles and responsibilities
  • Key components of an IT compliance governance strategy
  • 9:50 AUDITING SYSTEMS

    Earl Hulihan

    Earl Hulihan, Senior Vice President, Regulatory Consulting, META Solutions

  • Overview of major approaches
  • Regulatory standards
  • 10:30 Morning Coffee

    11:00 INSPECTION AND AUDITING OF COMPUTERISED SYSTEMS

  • Inspections - how to cope
  • Planning an audit
  • Developing an audit checklist
  • Evaluating SOPs governing system development, maintenance and support
  • Evaluating system development deliverables in relation to SOPs and industry standards
  • Preparing an audit report and addressing corrective action follow-up
  • Common findings in FDA inspections and audit
  • Peter  Bosshard

    Peter Bosshard, Quality Manager, ROCHE

    11:40 COMPUTER VALIDATION CHECKS FOR USER ACCEPTANCE OF GXP APPLICATIONS

    Malcolm Knott

    Malcolm Knott, Managing Director, Industrial Technology Systems

  • GxP regulations and compliance
  • The application of GxP regulations - what is their purpose?
  • Key requirements and what they mean for the company
  • Status of implementation
  • Consequence of non-compliance
  • Responsibilities
  • 12:20 Networking Lunch

    14:00 INTEGRATING INDUSTRY BEST PRACTICES

    Siegfried Schmitt

    Siegfried Schmitt, Quality Director, GE Healthcare

  • Lean, six sigma and validation- the good practices
  • Bringing these methodologies together
  • Leveraging lean and six sigma for validation
  • Making the business case- the cost of compliance
  • 14:40 FDA'S CURRENT THINKING ON PART 11 AND A PRACTICAL APPROACH FOR CSV

  • Summary of the code of federal regulations and EU regulation
  • Overview of 21 CFR Part 11
  • Changes in the interpretation and enforcement of Part 11
  • Impact of FDA's risk-based approach
  • Implementing a practical approach for CSV
  • Karin Ostergren

    Karin Ostergren, Associate Director QA Computerised Systems, Quality Assurance, AstraZeneca

    15:20 VALIDATION AND LABORATORY DATA ARCHIVING CHALLENGES

  • Introduction and background
  • Validation and electronic data archiving
  • World-wide regulations on electronic data archiving and management
  • Electronic data archiving challenges
  • Methods of archiving - languages for disparate systems
  • The one solution - XML in archiving
  • Future trends in archiving regulations
  • Bhanu Sharma

    Bhanu Sharma, Global Quality, Validation and Documentation, Bayer

    16:00 Chairperson's Closing Remarks Followed by Afternoon Tea, Close of Conference

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    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

    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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