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If you want to keep up to date with the recent developments and advances in laboraorty equipment, the easiest way is to attend SMi’s Laboratory Equipment Validation conference. SMi’s event offers you the simple way to stay ahead of the game, by covering the latest hot topics in Laboratory equipment and its application to the drug and bio-pharma industries.

The conference aims to show how the regulatory forces are driving the validation of laboratory euipment and how these developments are impacting on the drug and bio-pharma players. It will bring together leaders in the fields of pharmaceutical research and development, and the bio-pharma world to share up to date information about the current situation surrounding this exciting field, and to analyse the future of the industry. As a senior industry executive, you will be aware of the importance and potential of this field. This conference offers you the opportunity to discover the potential and realities of oncology research, to match your company’s resources to the needs of drug discovery

Conference programme

9:00 Registration and Coffee

9:30 Chairman's Opening Remarks

Dr Paul Baker

Dr Paul Baker, Senior Consultant, Bovis Lend Lease Pharmaceuticals

9:40 VALIDATION

Dr Tony Margetts

Dr Tony Margetts, International Project Manager, AstraZeneca

  • Validation objectives
  • The importance of a validation team: their role & responsibilities
  • Simple rules for effective validation project management
  • Can validation be efficient
  • Prospective, concurrent & retrospective validation
  • Future developments in validation
  • 10:20 REGULATORY EXPECTATIONS

    Ashley Hankinson

    Ashley Hankinson, Global Head Quality and Compliance Management, Janssen Research Foundation & RW Johnson Pharmaceutical Research Institute

  • Understanding the rationale behind FDA and MCA expectations
  • Interpreting the guidelines accurately
  • Understanding the difference between, calibration, verification, qualification and validation
  • Assessing compliance gaps
  • A review of current guidelines
  • Looking at past failures for future successes
  • 11:00 Morning Coffee

    11:20 PREPARING FOR FDA INSPECTIONS OF COMPUTERISED LABORATORY SYSTEMS

    Monica Cahilly

    Monica Cahilly, President, Green Mountain Quality Associates

  • Developing a master plan for computer systems validation and 21 CFR Part 11 compliance
  • Implementing a strategy to mitigate immediate compliance risks
  • Assigning responsibilities to appropriate personnel
  • Hypothetical conduct of the inspection
  • FDA 483s and warning letters
  • 12:00 VALIDATION DOCUMENTATION

    Dr Paul Baker

    Dr Paul Baker, Senior Consultant, Bovis Lend Lease Pharmaceuticals

  • What needs to be documented in the validation process
  • The variety of documentation types
  • Defining strategies for achieving goals
  • Identifying strengths and weakness in information
  • The validation master plan: when is it necessary?
  • 12:40 Networking Lunch

    14:00 LIFE CYCLE-BASED COMPUTER VALIDATION

    Barbara Mullendore

    Barbara Mullendore, Director, Technical Operating Processes, AstraZeneca

  • Regulators expectations
  • The life cycle-based approach to computer validation
  • Creating a computer validation plan
  • 14:40 CHROMATOGRAPHIC DATA SYSTEMS

    Huber Ludwig

    Huber Ludwig, Worldwide Product Marketing Manager, Agilent Technologies

  • The fundamentals
  • Understanding the regulations and guidelines
  • The problems encountered when validating systems
  • Practical solutions
  • Complying with 21 CFR Part 11, GLP & GMP
  • Maintaining system validation and keeping up to date on regulations

    Recording and archiving data

  • 15:20 Afternoon Tea

    15:40 21 CFR PART 11

    David Harrison

    David Harrison, Senior Consultant, ABB Eutech

  • How has 21 CFR Part 11 changed the laboratory computer and software validation requirements
  • What is the impact of 21 CFR Part 11 on our validation activities
  • What are the additional validation requirements
  • Ensuring technical compliance and reliance on the supplier
  • Achieving compliance or making a pragmatic stance
  • How can we minimise the impact and use 21 CFR Part 11 to benefit our operations
  • 16:20 VALIDATION PROTOCOLS

    Dr Rodney Thompson

    Dr Rodney Thompson, Senior Consultant, BioProcess Technology Consultants

  • The requirements of an effective protocol
  • Developing templates for validation protocols
  • Writing and executing process validation protocols
  • Harmonisation of and consistency between protocols
  • Equipment/utility/facility qualification protocols
  • 17:00 Chairman's Closing Remarks and Close of Day One

    9:00 Re-registration and Coffee

    9:30 Chairman's Opening Remarks

    Ashley Hankinson

    Ashley Hankinson, Global Head Quality and Compliance Management, Janssen Research Foundation & RW Johnson Pharmaceutical Research Institute

    9:40 VALIDATING COMPUTERISED SYSTEMS

    Niels Holger Hansen

    Niels Holger Hansen, Vice President, Quality Support, Novo Nordisk

  • FDA expectations
  • EU expectations
  • Creating and implementing a computer validation plan
  • Maintaining a validated state of a system
  • Increasing the effectiveness of computer validation programmes
  • The future of computer validation
  • 10:20 EQUIPMENT QUALIFICATION

    Dr Brian Davies

    Dr Brian Davies, Technology Manager, Perkin-Elmer

  • Understanding and applying DQ/IQ/OQ & PQ to a validation programme
  • What should be included within each qualification
  • DQ & the vendor qualification dilemma
  • How to perform IQ/OQ/PQ most cost effectively
  • The documentation that should be available at the end of equipment qualification
  • When to re-validate
  • 11:00 Morning Coffee

    11:20 VENDOR & LABORATORY

    Brigitte Staecker

    Brigitte Staecker, Validation Consultant, ThermoLabsystems

  • Who writes requirements?
  • Who writes validation documentation?
  • What is the best use of IQ kit? Vendor runs it, or lab?
  • What is the best use of the OQ kit? Vendor runs it, or lab?
  • What is in PQ? Who writes it? Vendor runs it, or lab?
  • How to configure to system for Part 11 compliance – vendor or lab?
  • 12:00 AUTOMATED SAMPLE PREPARATION SYSTEMS

    Randy Estes

    Randy Estes, President/ Senior Validation Consultant, Laboratory Validation & Services

  • What is an automated system?
  • Define the validation approach
  • Dealing with multi-vendor modules configured into the system
  • 21 CFR Part 11 considerations
  • Method validation – this too?
  • Keeping the system validated
  • 12:40 Networking Lunch

    14:00 VALIDATION AUDITING

    Elien Young

    Elien Young, Functional Quality Manager, Novartis

  • Timing of an audit
  • How to audit
  • Practical approaches to an audit
  • Auditing from a regulators perspective
  • Performing audits
  • Auditing equipment vendors
  • 14:40 DEALING WITH FAILURE

    Mark Broughton

    Mark Broughton, Head, Analytical Technology, Aventis

  • Handling out of specification results
  • Use of a defined procedure for investigation
  • Establishing an investigation team
  • What can be learnt from out of specification results
  • Root cause analysis
  • Implementing preventative procedures

    What can be learnt from regulatory body citations

  • 15:40 PANEL DISCUSSION

    16:20 Chairman's Closing Remarks and Close of Conference

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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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