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The pharmaceutical industry relies heavily on IT systems throughout the whole process from compound discovery to marketing the drug. One crucial but easily neglected area is validation of corporate IT systems. Validation of IT systems in pharmaceutical manufacturing is essential for protecting the quality of healthcare products while ensuring compliance with the strict regulatory requirements of bodies such as the MCA and the FDA.

The Validation of Corporate IT Systems in the Pharmaceutical Industry will include senior industry figures presenting case studies on implementation and validation of business systems such as LIMS, EDMS and MRPII. The conference will explore issues concerning cost effectiveness, understanding the GMP regulations, the degree of validation required in order to meet the regulations, risks, infrastructure and many more essential issues surrounding corporate IT system validation.

For those new to the field of validation, come along and gain vital insight and understanding of this critical area. Leading experts in the field will also provide more advanced knowledge and best practice using real life case studies for those with more experience.

This conference is vital for those involved in pharmaceutical manufacturing to gain essential knowledge in order to fully appreciate and use your business information systems to the most strategic advantage.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Paul Herremans

Paul Herremans, Quality Assurance Manager, IT, Janssen Pharmaceutica

9:10 AN OVERVIEW OF CORPORATE IT SYSTEMS

Dr Tony Margetts

Dr Tony Margetts, International Project Manager, AstraZeneca

  • Defining corporate IT systems
  • Defining GMP requirements
  • Defining validation in terms of IT systems
  • Implications of validation requirements to the business
  • What are we striving to achieve with IT in the pharmaceutical industry?
  • Benefits of successful validation of corporate IT systems
  • 9:40 UNDERSTANDING THE GOOD MANUFACTURING PRACTICE (GMP) GUIDELINES

    Robert Bronstein

    Robert Bronstein, President, Software Applications Division, Base Ten Systems

  • Requirements of the GMP regulations
  • Assuring consistency in pharmaceutical products and processes
  • Impact of the regulations on the global pharmaceutical industry
  • Defining and controlling the critical variables
  • Ensuring end-product homogeneity and conformity with appropriate regulations
  • Interpreting the regulations for successful validation
  • 10:20 VALIDATION PROJECTS AND RISK ASSESSMENT

    Chris Reid

    Chris Reid, Principal Consultant, Integrity Solutions & Member, European Steering Committee, (GAMP)

  • Understanding risks involved with validation projects
  • Assessing the level of risk
  • Implementing successful risk management strategies
  • Effective change management
  • Implementing successful change management techniques
  • 11:00 Morning Coffee

    11:20 ELECTRONIC DOCUMENT MANAGEMENT SYSTEMS (EDMS)

    Dr Ruediger Buchkremer

    Dr Ruediger Buchkremer, Head, Department of Scientific Information and Documentation, Project Leader EDMS, Byk Gulden

  • Harmonisation of project management and validation documentation in a large international project
  • Influence on processes in the submission chain
  • Effective validation of the EDMS
  • Complying with validation requirements for EDMS
  • Understanding the component technologies of an EDMS
  • Understanding current and future EDMS needs; Effective documentation management strategies
  • 12:00 IMPLEMENTING LABORATORY INFORMATION MANAGEMENT SYSTEMS (LIMS)

    Simon Thomson

    Simon Thomson, Validation and Regulatory Affairs Officer, LabSystems

  • How validation requirements affect LIMS
  • Increased requirements for ease of validation of hardware, systems and processes
  • Managing and controlling LIMS
  • Successful implementation of a sustainable LIMS
  • Implementing an effective LIMS strategy
  • LIMS selection criteria
  • 12:40 Lunch

    14:00 WORKING WITH AN EFFECTIVE LABORATORY INFORMATION MANAGEMENT SYSTEM

    Robert Cleave

    Robert Cleave, Quality Assurance IT Manager, Boots Contract Manufacturing

  • Benefits of a successful LIMS to pharmaceutical manufacturing
  • Applications of LIMS
  • Meeting regulatory requirements with LIMS
  • Understanding validation documentation and SOPs associated with LIMS
  • Executing a LIMS validation
  • 14:40 IMPLEMENTING A MANUFACTURING RESOURCE PLANNING SYSTEM (MRPII)

    Erik Degn

    Erik Degn, Director, Health Care IT, Novo Nordisk

  • Scope of the MRPII implementation
  • Evaluating and selecting the appropriate vendor and software package
  • Special issues and requirements in pharmaceutical manufacturing
  • Integration with other enterprise systems and Manufacturing Execution Systems
  • Validating the MRPII implementation
  • Effective operations and support of the MRPII system
  • 15:20 Afternoon Tea

    15:40 EFFECTIVE SUPPLY CHAIN PLANNING AND PRODUCT LIFE-CYCLE MANAGEMENT

    Dave Alberts

    Dave Alberts, Principal, World Class International

  • Understanding supply chain constraints
  • World class supply chain design principles
  • Strategic, tactical and operational supply chain processes
  • Planning and control techniques; how to select and use the best techniques to improve customer service, reduce supply chain costs and improve responsiveness
  • Providing superior customer value through effective supply chain designed execution
  • Speed; the key differentiator
  • 16:20 IMPROVING QUALITY ASSURANCE THROUGH VALIDATION

    Jacqui Farini

    Jacqui Farini, Production Support Section Manager, Pfizer

  • Validating software in secondary dosage form equipment
  • Using appropriate validation methodology
  • Optimising productivity through correct validation
  • Ensuring regulatory requirements are met
  • Maintaining validated status
  • 17:00 E-Solutions in FDA regulated environments

    Kyle McDuffie

    Kyle McDuffie, Director, Quality Assurance, CB Technologies, Inc

  • Definition and examples of E-solutions in regulated environments (GMP/GCP/GLP)
  • Benefits of implementing these types of systems over traditional client-server
  • Impact of 21 CFR Part 11
  • Specific Validation challenges associated with these systems
  • Tools to meet the regulatory challenges
  • 17:30 Chairman’s Closing Remarks and Close of Day One

    17:40 Drinks Reception For Delegates And Speakers

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Frances Bruttin

    Frances Bruttin, Service Line Leader, European Validation and Compliance Service, Pharmaceutical Sector Team, PricewaterhouseCoopers

    9:10 CONTRIBUTIONS OF VENDORS FOR VALIDATION OF COMPUTER SYSTEMS

    Dr Ludwig Huber

    Dr Ludwig Huber, Product Marketing Manager, Agilent Technologies

  • Responsibilities of vendor and user firms
  • Validation during development
  • Qualification of the vendor
  • Assistance from the vendor for DQ, IQ, OQ and PQ
  • Long term archiving and reprocessing data for 21 CFR Part 11
  • Required validation documents from a vendor
  • 9:40 IT INFRASTRUCTURE VALIDATION

    Stephen Summers

    Stephen Summers, Principal Consultant, Newburn Consulting

  • Separating infrastructure from applications so that validation can be planned
  • Understanding what is best practice in infrastructure management
  • Validation of infrastructure and ‘best practice’ management
  • Impact on validation of outsourcing infrastructure services - maintaining a validated service at arm’s length
  • 10:20 WORKING WITH ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

    Dr Jennifer Methfessel

    Dr Jennifer Methfessel, Validation Consultant, Eutech

  • Conducting 21 CFR Part 11 assessments
  • Managing and mining the assessment information
  • 21 CFR Part 11, GLP and validation
  • Case study 1: LIMS; Case study 2: Networked and stand alone HPLC systems
  • An overview of practical problems encountered and some solutions
  • Changes in culture and practice initiated by 21 CFR Part 11
  • 11:00 Morning Coffee

    11:20 COMPUTER SYSTEM VALIDATION (CSV)

    Ann C Puskaric

    Ann C Puskaric, Regional Sales Manager, Former Senior Validation Scientist, PharmComm

  • Increasing efficiency of CSV projects
  • Reducing cycle time for CSV projects
  • Involving the users in the validation process
  • Advantages of user involvement over rapid turn-key validation
  • Defining and testing the relevant computer system components to ensure consistent and correct operation
  • Knowing what to validate and how much to validate
  • 12:00 EFFECTIVE VALIDATION PLANNING AND STREAMLINING

    Mark Brazier

    Mark Brazier, Associate Director, Information Systems Consulting, KMI/Parexel

  • Understanding the degree of validation required
  • The importance of effective validation involvement and planning early in the project
  • Use of the System Development Life Cycle and project
  • Defining the validation planning strategy
  • Validation programme implementation
  • Validation added value
  • 12:40 Lunch

    14:00 FAST-TRACK PROJECT VALIDATION: FACT OR MYTH?

    Dave Cosgrove

    Dave Cosgrove, Northwest Regional Manager, Raytheon

  • Top-end client interface and buy-in
  • Defining the project
  • Building the project team
  • Understanding the barriers to successful ‘fast track’ validation
  • Managing the project
  • Change control procedures and processes
  • 14:40 EFFECTIVE IMPLEMENTATION IN A VALIDATED ENVIRONMENT

    Anne O’Riordan

    Anne O’Riordan, Experienced Manager, Andersen Consulting

  • Orchestrating the holistic approach
  • People, processes, technology and long term service
  • Avoiding the common pitfalls
  • Tackling the problems successfully
  • 15:20 Afternoon Tea

    15:40 QUALIFICATION WITHIN THE SCOPE OF VALIDATION

    Dr Thomas Müller-Heinzerling

    Dr Thomas Müller-Heinzerling, Senior Manager, Control System Validation, Siemens

  • Supplier qualification - what to look for in your supplier (GAMP NE72)
  • Qualification activities during project execution - how to proceed in an efficient way (GAMP NE58)
  • Validation supporting control system functions - what to look for in your control system (GAMP NE72)
  • Tips and tricks to reduce the qualification effort
  • Tools to support qualification activities
  • 16:20 COMPETING FOR THE FUTURE

    Dr Christoph Herrmann

    Dr Christoph Herrmann, Head of Good Dataprocessing Practices, Schering AG

  • Why it is beneficial to have corporate IT policies
  • Validation and IT security are not the only topics
  • Balancing guidance and bureaucracy
  • Organising the process of generating and implementing IT policies
  • Possible impact on the base line
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    IT and Sales & Marketing: the Search for a Common Language
    Workshop

    IT and Sales & Marketing: the Search for a Common Language

    The Hatton, at etc. venues
    4th July 2000
    London, United Kingdom

    IT and Sales & Marketing: the Search for a Common Language
    Workshop

    IT and Sales & Marketing: the Search for a Common Language

    The Hatton, at etc. venues
    4th July 2000
    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

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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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