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Following on from our hugely successful pharmaceutical microbiology conference in 2011 SMi 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.
 

Microbial contamination of products and processes in a lab and manufacturing environment continues to pose a major problem to the Pharmaceutical and Biotechnological industries and its regulators. Attendees will be presented with a series of case studies of recent developments along with practical methods and examples of how to effectively manage your sterile environment.

  • The latest tools, techniques, and procedures used in the identification and control of contaminants
  • Sterile production and handling of traditional drugs and biologics
  • Design, construction, and validation of sterile facilities and equipment
  • New Rapid Microbial Methods to test and detect for the presence of contaminants
Microbiologists
Biological manufacture and production
Quality Control and Quality Assurance
Antimicrobial and biocide research
 
Biotech Research and Development
Sterile lab management
Validation and Regulatory affairs
Sterile facilities design and construction
 

Alfa Wassermann BV; Astrazeneca; Barts and The London NHS Trust; Becton Dickinson Gmb H; Bio Products Laboratory; BioMerieux; Blenkharn Environmental; Bovis Lend Lease Pharmaceuticals; Celsis; Celsis Ltd; Genentech; Genzyme ; Glaxochem Ltd; GlaxoSmithKline; Johnson & Johnson; Med Pharma Service; MedImmune; Merck Millipore; MHRA; Ministry of Health; Moorfields Pharmaceuticals; Novo Nordisk A/S; Patheon Italia SpA; Patheon UK Ltd; Pfizer; Qualitest Pharmaceuticals, Inc.; Reckitt Benckiser Healthcare; Sanofi-Aventis Ltd Dagenham; schering Plough; STERIS Corporation; University Of Cambridge; Wickham Laboratories Ltd;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Olivier Chancel

Olivier Chancel, Head of Pharmaceutical Support, Merial Sas

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
  • 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
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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
  • 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
  • 15:00 Afternoon Tea

    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
  • 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
  • 17:00 Chairman's closing remarks and end of day one.

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Scott Smith

    Scott Smith, Microbiology QC leader, Sanofi-Aventis

    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
  • 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

    10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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
  • 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
  • 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
  • 15:40 Chairman's closing remarks and close of day two.

    15:45 Afternoon Tea

    +

    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

    Marriott Regents Park

    128 King Henry's Road
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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, 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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