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Pharmaceutical Microbiology
30 January - 31 January 2013
Pharmaceutical Microbiology

Following on from our hugely successful pharmaceutical microbiology conference in 2011 SAE Media Group will provide a global forum for senior level decision makers and those working within microbiology fields to meet.

Pharmaceutical Microbiology 2013 aims to concentrate on recent developments in lab design, new latest trends in sterility & decontamination and demonstrations of new technologies such as advances in rapid microbial methods.

Our two-day conference will provide useful insights into the latest developments within Pharmaceutical Microbiology. With an international array of speakers, enhance your product launches or your own new developments with key decision makers from big pharma, biotech and academia.
 

FEATURED SPEAKERS

John Duguid

John Duguid

Principal Process Analytical Scientist, Genzyme
Scott Smith

Scott Smith

Microbiology QC leader, Sanofi-Aventis

Andrew Bartko

Senior Scientist, Battelle Memorial Institute
Andrew Bartko

Ann Warford

Associate Director, Quality Control, MedImmune
Ann Warford

Brendan Gilmore

Senior Lecturer in Pharmaceutical Microbiology, Queen's University Belfast
Brendan Gilmore

Christoph Leucht

International Marketing Manager, Roche Custom Biotech
Christoph Leucht

Elaine Nichols

European Technical Support Manager, ThermoFisher
Elaine Nichols

Hilary Chan

Quality Scientist IV , Pfizer
Hilary Chan

John Duguid

Principal Process Analytical Scientist, Genzyme
John Duguid

Kim Bowers

Manager, Pfizer
Kim Bowers

Kristian Agnew

Associate Director of Engineering, Merck & Co.
Kristian Agnew

Laura Barberis

Scientist, Merck
Laura Barberis

Olivier Chancel

Head of Pharmaceutical Support, Merial Sas
Olivier Chancel

Pranav Somaiya

Lead Researcher, University College London (Sponsored by bioMérieux)
Pranav Somaiya

Scott Smith

Microbiology QC leader, Sanofi-Aventis
Scott Smith

Stephen Rawling

Microbiology Team Leader, GlaxoSmithKline
Stephen Rawling

Victoria Girard

R&D Microbiology Manager, bioMérieux SA
Victoria Girard

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Olivier Chancel

Olivier Chancel, Head of Pharmaceutical Support, Merial Sas

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9:10

Monograph <1207> - Sterile product packaging is nice – Integrity evaluation is even better

Olivier Chancel

Olivier Chancel, Head of Pharmaceutical Support, Merial Sas

  • Share a global and rationalised approach to control container closure integrity at the best price
  • Initial qualification – microbial ingress testing to validate both the stopper / bottle association and the crimping parameters
  • In process control – seal force testing to control the line in sealing process through the filling of commercial batches
  • Stability studies – universal vacuum test to confirm container and closure system integrity as part of the stability protocol
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    9:50

    Selection, validation and automation of rapid mycoplasma test

    John Duguid

    John Duguid, Principal Process Analytical Scientist, Genzyme

  • Selection using a risk based approach
  • Validation according to PhEur 2.6.7
  • Automation for routine testing
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    10:30

    Morning Coffee

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    11:00

    Non thermal plasmas for disinfection, sterilisation and contamination control

    Brendan Gilmore

    Brendan Gilmore, Senior Lecturer in Pharmaceutical Microbiology, Queen's University Belfast

  •  The emerging field of plasma medicine and biocidal plasmas
  • Antimicrobial, antibiofilm and anti viral activity of non-thermal plasmas
  • Mechanisms of action and potential applications in pharmaceutical microbiology
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    11:40

    Rapid microbiology from a manufacturing perspective: available technologies and potential applications

    Hilary Chan

    Hilary Chan, Quality Scientist IV , Pfizer

  • Manufacturing perspective on rapid microbiology including case studies
  • Overview of technologies and potential applications
  • Potential for moving testing to the manufacturing floor
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    12:20

    Networking Lunch

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    13:40

    Superheat phenomena in autoclaves

    Kristian Agnew

    Kristian Agnew, Associate Director of Engineering, Merck & Co.

  • The phenomena of superhead and its relevance to sterilisation
  • Technologies available to detect superheat conditions
  • Variability found in commonly used daily steam quality tests
  • clock

    14:20

    Creation and use of in-house naturally occurring endotoxin preparation for spiking and hold time studies

    Kim Bowers

    Kim Bowers, Manager, Pfizer

  • Creation of an in-house Naturally Occurring Endotoxin (NOE) preparation: organism choice, growth conditions etc
  • Use of NOE in endotoxin spiking and hold time studies: design of studies, recommended controls to use
  • Difference between design and execution of hold time studies and LAL validation studies
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    15:00

    Afternoon Tea

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    15:30

    Auditing suppliers to ensure product quality

    Ann Warford

    Ann Warford, Associate Director, Quality Control, MedImmune

  • Recent history of bioreactor contaminations
  • Regulatory expectations for biopharmaceuticals
  • Raw material sampling, storage and transport best practices
  • Environmental control expectations and use of QC in process and environmental testing
  • Case study of audit finding cases
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    16:10

    Using the MycoTOOL® PCR mycoplasma detection kit for release of biopharmaceutical products

    Christoph Leucht

    Christoph Leucht, International Marketing Manager, Roche Custom Biotech

  • Regulatory considerations for validation of an alternative, PCR-based mycoplasma detection method intended for final release 
  • Advantages of implementing a rapid release test in the Pharma QC environment
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    17:00

    Chairman's closing remarks and end of day one.

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Scott Smith

    Scott Smith, Microbiology QC leader, Sanofi-Aventis

    clock

    9:10

    Effective microbial investigations

    Scott Smith

    Scott Smith, Microbiology QC leader, Sanofi-Aventis

  • Trigger points, laboratory failure and sample validity
  • Collaboration and team work
  • Manufacturing plant investigating
  • Contributing fators, risk asses, conclusions and CAPA
  • clock

    9:50

    Revolutionising microbial Identification with mass spectrometry technology

  • Development of MALDI-TOF technology
  • Application for Microbial identification
  • VITEK MS: MALDI-TOF for the microbiologist
  • Performance
  • Database, Algorithm and Software Development for Industry
  • Regulatory Acknowledgement
  • The future of VITEK MS, identification and beyond
  • Pranav Somaiya

    Pranav Somaiya, Lead Researcher, University College London (Sponsored by bioMérieux)

    Victoria Girard

    Victoria Girard, R&D Microbiology Manager, bioMérieux SA

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    10:30

    Morning Coffee

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    11:00

    Molecular biology methods for viral safety: danger tool or perfect solution

    Laura Barberis

    Laura Barberis, Scientist, Merck

  • The perception of using molecular biology and PCR based testing
  • Faculty design, GMP compliance and highly trained personnel make a difference
  • Results
  • Conclusions and validations for biopharmaceuticals quality control
  • clock

    11:40

    Integrated microbial and contaminant identification in manufacturing process water

    Andrew Bartko

    Andrew Bartko, Senior Scientist, Battelle Memorial Institute

  • Emerging rapid microbial methods
  • Spectroscopic microbial identification
  • Manufacturing process water quality
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    12:20

    Networking Lunch

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    13:40

    Microbial risk assessment of objectionable organisms

    Stephen Rawling

    Stephen Rawling, Microbiology Team Leader, GlaxoSmithKline

  • Microbial risk assessment is a structured approach based on science that can be applied to the risk management of objectionable organisms
  • The elements, hazard characterisation, exposure assessment and risk characterisation
  • Microbial risk assessment allows transparent and effective decision making
  • clock

    14:20

    Development of Culture Media for Media Fills

    Elaine Nichols

    Elaine Nichols, European Technical Support Manager, ThermoFisher

  • Requirements of the Pharmaceutical Industry
  • Mycoplasma Contamination and Filtration Process Simulation
  • Product Development
  • Product Testing
  • clock

    15:00

    Assessment of solution and raw material microbial stability and testing requirements in a non-sterile manufacturing environment

    Hilary Chan

    Hilary Chan, Quality Scientist IV , Pfizer

  • Use of a multi-faceted evaluation tool, including water activity, for establishment of non-sterile solution expiry based on microbial stability/survivability
  • Use of the same approach for determining appropriate microbial testing of non-sterile raw materials
  • Implementation of a procedure for assessing solutions and raw materials allows a greater understanding of microbial stability, reduction in testing requirements, and a streamlined documented approach for audit preparedness
  • clock

    15:40

    Chairman's closing remarks and close of day two.

    clock

    15:45

    Afternoon Tea


    Quality Scientist IV
    Pfizer
    Manager
    Pfizer
    Head of Pharmaceutical Support
    Merial Sas
    Lead Researcher
    University College London (Sponsored by bioMérieux)
    R&D Microbiology Manager
    bioMérieux SA
    International Marketing Manager
    Roche Custom Biotech
    Scientist
    Merck
    European Technical Support Manager
    ThermoFisher
    Microbiology QC leader
    Sanofi-Aventis
    Associate Director of Engineering
    Merck & Co.
    Senior Lecturer in Pharmaceutical Microbiology
    Queen's University Belfast
    Principal Process Analytical Scientist
    Genzyme
    Microbiology Team Leader
    GlaxoSmithKline
    Senior Scientist
    Battelle Memorial Institute
    Associate Director, Quality Control
    MedImmune

    Marriott Regents Park

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    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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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, SAE Media 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@saemediagroup.com

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