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SMi’s reputable Pharamceutical Microbiology conference returns for its 3rd year. The event is due to take place in London, UK, on 20th and 21st January, 2014.

Building upon last year’s successful event, Pharmaceutical Microbiology 2014 will draw upon the experiences and knowledge experts and specialists from around the globe to provide first-class presentations and stimulating discussions.

The conference will aim to focus on the regulatory aspect, with topics addressing preparations for auditing, what to expect during the inspection process, and how to rectify poor situations. There will also be considerable spotlight on novel rapid methods, case studies from the USA, their implementation, and the current regulatory view on methods. Among these hot topics, popular talks from last will return and examine sterility assessment, risk management, and contamination control.

  • Regulatory body representation and update – what to expect from inspection, how to prepare your lab, and how to rectify situations when things go wrong.
  • Discover cutting edge rapid methods, how to implement the technology, and the regulatory stance
  • Hear specialist advice on contamination control and risk management to minimise costs and maximise efficiency
  • Learn about hot topics which include objectionable organisms, viral contaminations, update on the pharmacopeias, and quality by design.
  • Discuss case studies and experiences with expert speakers and delegates from across the UK, USA, and Europe.

This event is unmissable for the following:

Microbiologists
Biological manufacture and production
Quality Control
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 Return of experience: unexpected observations during vial depyrogenation by water for injection rinsing

Olivier Chancel

Olivier Chancel, Head of Pharmaceutical Support, Merial Sas

  • Differences observed between plastic and glass vials
  • Depyrogenation of Glass - a need?
  • Risk analysis: management of depyrogenated glass vials
  • 9:50 Cleanroom behaviour, aseptic practices and operator understanding

    Phil Duncanson

    Phil Duncanson, Site Microbiologist & QC Lead, MedImmune

  • Developing a feedback and learning culture around cleanroom behaviour
  • Evaluating operator cleanroom behaviour
  • Avoiding common regulatory observations around aseptic technique
  • Relating operator performance to environmental monitoring excursions
  • 10:30 Morning Coffee

    10:50 Real-time microbial air sampling in operational cleanrooms

    Tim Eaton

    Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca PLC

  • Introduction to real-time microbial air samplers
  • Evaluation in operational cleanrooms and critical zones
  • Interpretation of the data
  • The future of real-time microbial air sampling
  • 11:30 "Objectionable Organism" - Who cares?

    Peter Penn

    Peter Penn, International sales & Marketing Manager, Microbiologics

  • What objectionable organisms are
  • The harm they can cause
  • How they get into products (environment, raw materials, personnel, water etc.)
  • What is currently available to assist you in dealing with objectionable organisms
  • 12:10 Maximizing your microbiological toolkitfor improved contamination responsiveness

    Lynn Johnson

    Lynn Johnson, Quality Scientist, Pfizer

  • An approach to facilitate a faster, more effective contamination response
  • Choosing the appropriate tools for supportive testing
  • Understanding the strengths and weaknesses of the methods in relation to the investigation
  • Developing a base knowledge, through experimentation and research, to enhance understanding and improve preparedness
  • 12:50 Networking Lunch

    14:00 ISO 14644 revision of parts 1 & 2: new dedicated methods for classification and monitoring of air cleanliness by particle measurement

    John Hargreaves

    John Hargreaves, Managing Director, JHAC

  • Role of Particle counting
  • Classification: representing the clean zone or room
  • Particle counting methods
  • Monitoring in operation
  • Technical Standard and GMP
     
  • 14:40 Non thermal plasmas in infection and contamination control - where are we now?

    Sarah Higginbotham

    Sarah Higginbotham, Research Fellow, Queens University Belfast

  • The development of non thermal plasmas has given rise to the emerging field of plasma medicine
  • Discussion of the translation of this exciting technology into pharmaceutical microbiology and infection control applications
  • New insights into mechanisms of action of non thermal plasma against bacterial biofilms
  • Future opportunities
  • 15:20 Preparing for pharmaceutical microbiology inspections

    Di Morris

    Di Morris, Consultant, Pharmaceutical Solutions Ltd.

  • Overview of inspection process
  • What inspectors are looking for
  • Microbiological investigations
  • 16:00 Afternoon Tea

    16:30 The human oral microbiome and oral care products

    William Wade

    William Wade, Professor of Oral Microbiology, Barts and The London School of Medicine and Dentistry

  • The composition of the human oral microbiome
  • The role of the microbiome in tooth decay and gum disease
  • Chemical control of dental plaque
  • Potential for probiotics in control of oral disease
  • 17:10 Antimicrobial preservation by design

    Stephen Rawling

    Stephen Rawling, Microbiology Team Leader, GlaxoSmithKline

  • Why design preservative systems
  • Preservative system design / working with the formulator
  • Self preserving formulations
  • Antimicrobial efficacy tests
  • 17:50 Chairman’s closing remarks and close of day one

    8:30 Registration & Coffee

    9:00 Chairman's opening remarks

    Andrew Bartko

    Andrew Bartko, Senior Scientist, Battelle Memorial Institute

    9:10 Rapid contaminant sensing and Microbial identification

    Andrew Bartko

    Andrew Bartko, Senior Scientist, Battelle Memorial Institute

  • Overview of optical rapid microbial methods
  • Implementation objectives
  • In-line integration results
  • Continuous process monitoring results
  • 9:50 Lean Microbiology for the QC laboratory through automation, quality and cost

    Anna Mills

    Anna Mills, Senior Field Application Specialist, Rapid Micro Biosystems Inc

  • Principles and challenges of being Lean in Micro QC
  • Identification of Waste
  • Lean through Automation
  • 10:30 Morning Coffee

    10:50 Rapid Microbiological methods in autologous cell therapy: Advantages, limitations, support, and obstacles

    John Duguid

    John Duguid, Principal Process Analytical Scientist, Genzyme

  • Autologous cell therapy products have short shelf-lives measured in hours or days
  • Products with short shelf-lives often require same day lot release
  • Rapid microbiological methods (RMM) exist for sterility, endotoxin, and Mycoplasma
  • Regulators have approved RMM for in-process and lot release testing
  • 11:30 Implementation of real time PCR testing in the QC Microbiology Laboratory

    Kim Bowers

    Kim Bowers, Manager, Pfizer

  • Use of commercially available real time PCR kits for in-process Mycoplasma and MMV screening and for microbial identification testing
  • Benefits of PCR RMM’s: cost, control and time to result
  • Qualification/validation approach and strategy
  • Implementation challenges
  • 12:10 Networking Lunch

    13:30 The Operational Benefit of a Customized MALDI-TOF Library for the Identification of Environmental Microorganisms

    Ulrich Herber

    Ulrich Herber , Senior European Product Manager, Charles River

  • Overview of how MALDI-TOF technology works
  • Challenges of making MALDI-TOF library entries
  • Impact of adding EM relevant entries to ID performance
  • Case Studies
  • 14:10 QPs and Microbiologist how to build a great partnership

    Mary-Anne Weatherhead

    Mary-Anne Weatherhead, Qualified Person, Pfizer

  • What useful information can the Microbiologist supply to the QP
  • How to make a QP interested in your data
  • What data to leave out
  • Why should Microbiologists become QPs
  • 14:50 Afternoon Tea

    15:20 The FDA Drug Product Review process: Microbiological considerations

    Steven Donald

    Steven Donald, Microbiologist, FDA

  • Microbiological concerns in the manufacturing process
  • Process validation expectations
  • Microbiological specifications for the drug product
  • Avoiding common deficiencies
  • 16:00 Current topics in regulatory review - The FDA perspective

    Erika Pfeiler

    Erika Pfeiler, Microbiologist, FDA

  • Issues related to specific classes of drug products will be identified (Burkholderia cepacia testing, post-reconstitution hold times, rapid microbiological methods)
  • FDA expectations for specific review issues will be discussed
  • Data requirements and testing strategies for submissions will be described
  • Common inadequacies in testing will be outlined
  • 16:40 Chairman’s closing remarks and close of day two

    +

    FEATURED SPEAKERS

    Di Morris

    Di Morris

    Consultant, Pharmaceutical Solutions Ltd.
    Erika Pfeiler

    Erika Pfeiler

    Microbiologist, FDA
    John Duguid

    John Duguid

    Principal Process Analytical Scientist, Genzyme
    Olivier Chancel

    Olivier Chancel

    Head of Pharmaceutical Support, Merial Sas
    Phil Duncanson

    Phil Duncanson

    Site Microbiologist & QC Lead, MedImmune
    Stephen Rawling

    Stephen Rawling

    Microbiology Team Leader, GlaxoSmithKline
    Tim Eaton

    Tim Eaton

    Sterile Manufacturing Specialist, AstraZeneca PLC

    Andrew Bartko

    Senior Scientist, Battelle Memorial Institute
    Andrew Bartko

    Anna Mills

    Senior Field Application Specialist, Rapid Micro Biosystems Inc
    Anna Mills

    Di Morris

    Consultant, Pharmaceutical Solutions Ltd.
    Di Morris

    Erika Pfeiler

    Microbiologist, FDA
    Erika Pfeiler

    John Duguid

    Principal Process Analytical Scientist, Genzyme
    John Duguid

    John Hargreaves

    Managing Director, JHAC
    John Hargreaves

    Kim Bowers

    Manager, Pfizer
    Kim Bowers

    Lynn Johnson

    Quality Scientist, Pfizer
    Lynn Johnson

    Mary-Anne Weatherhead

    Qualified Person, Pfizer
    Mary-Anne Weatherhead

    Olivier Chancel

    Head of Pharmaceutical Support, Merial Sas
    Olivier Chancel

    Peter Penn

    International sales & Marketing Manager, Microbiologics
    Peter Penn

    Phil Duncanson

    Site Microbiologist & QC Lead, MedImmune
    Phil Duncanson

    Sarah Higginbotham

    Research Fellow, Queens University Belfast
    Sarah Higginbotham

    Stephen Rawling

    Microbiology Team Leader, GlaxoSmithKline
    Stephen Rawling

    Steven Donald

    Microbiologist, FDA
    Steven Donald

    Tim Eaton

    Sterile Manufacturing Specialist, AstraZeneca PLC
    Tim Eaton

    Ulrich Herber

    Senior European Product Manager, Charles River
    Ulrich Herber

    William Wade

    Professor of Oral Microbiology, Barts and The London School of Medicine and Dentistry
    William Wade

    Workshops

    Aseptic Behavior, Feedback & Learning
    Workshop

    Aseptic Behavior, Feedback & Learning

    Marriott Regents Park
    22nd January 2014
    London, United Kingdom

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    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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