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Pharmaceutical microbiology is of crucial importance to the development and manufacture of pharmaceutical drugs, biologics and devices. Set to take place on the 21st and 22nd January 2015, the event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology

Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Hear presentations from the heart of industry, addressing real world case studies on the benefits and challenges of rapid methods, risk assessments and objectionable organisms. Share the wisdom of respected consultants and get the regulators perspective on recent changes and issues under review.

Discover the latest in the development and
management of sterilisation and validation
processes
Benefit from shared learning and case studies to
enhance your practice
Understand data review and analysis for
pharmaceutical microbiology
Tune in to developments in bioburden and biofilm
control strategies
Look in depth at issues of objectionable organism
management
Hear specialist advice on contamination control
and risk assessment to
 

Chief Executives, Vice Presidents, Heads, Directors, Chief Scientists, Principle Scientists, and Project Leaders, Managers, in:

  • Microbiologists
  • Biological manufacture and production
  • Quality control
  • Quality assurance
  • Antimicrobial and biocide research
  • Biotech research and development
  • Sterile lab management 
  • Sterile facilities design and construction
  • Compliance
  • Regulatory Affairs
  • Validation  

 

A snapshot of our previous delegates at the 2014 event included:

Abbott Biologicals B V; Aquachim; AstraZeneca; AstraZeneca PLC; Barts and The London School of Medicine and Dentistry; Battelle Memorial Institute; BPL; Charles River; Charles River EMD; Eden Biodesign Ltd; EMS Particle Solutions; FDA; Genzyme ; GlaxoSmithKline; Glaxosmithkline (Cork) Ltd; JHAC; MedImmune; Merck Serono - RBM; Merck Sharp & Dohme; Merial Sas; MHRA; MIcrobiologics; Novo Nordisk; Pall Corporation ; Pfizer; Pfizer Ireland Pharmacueuticals; Pharmaceutical Solutions Ltd.; PMT (GB) Ltd; Queens University Belfast; Rapid Micro Biosystems Inc; Rapid Test Methods Ltd.; Steris Corp; TECHNOPATH; University Of Cambridge; Wickham Laboratories Ltd

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Olivier Chancel

Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas

9:10 Twelve lessons learned on sterility assurance

Olivier Chancel

Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas

• Experience: a treasure box full of historical accidents, technical visit remarks
• Contamination occurred on one site, they may occur on your site too
• Some suggestions to prevent new contaminations

9:50 Relating microbial risk assessment to HACCP

Stephen Rawling

Stephen Rawling, Microbiology Team Leader, GlaxoSmithKline

• Where does microbiological risk assessment interact with HACCP?
• How microbiological quality may be impacted by the steps in the manufacturing process
• Evaluate steps within a process
• Control activities that may increase microbial contamination risk
 

10:30 Morning Coffee

11:00 Profound risk assessment using Hazard Analysis and Critical Control Point to control biologic contamination during manufacturing of biologic products

Stijn  Seels

Stijn Seels, Process Engineer Microbiology, Genzyme

• The HACCP tool (Hazard Analysis and Critical Control Points) in i) Viruses, ii) Bacteria, Fungi/mould and mycoplasma and iii) Endotoxin and Toxin contamination
• Good understanding of the manufacturing process was required to find the critical control points and GAPs with the current sampling plan
• Identifying future actions to control biologic contamination and reduce risk that may impact biologic product quality and safety
 

11:40 Latest approaches to preventing biofilms in water systems

Robert Neri

Robert Neri , Senior Scientist, Sanofi

• Overview of biofilms
• Prevention: Design point of use
• Prevention: Electrolytic ozone design
• Removal of biofilm

12:20 Networking Lunch

13:30 Assessment of microbial risk to patients from aseptically manufactured products

Tim Eaton

Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca PLC

• Likelihood of the product being contaminated during manufacture
• Treatments during manufacture that will deactivate micro-organisms
• The ability of microbes to multiply, survive or die during shelf life of the product

14:10 Development and management of sterilisation and validation processes

Jeanne Moldenhauer

Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting Inc

• Understanding validation and sterilisation processes
• Defining validation requirements that will be part of regulatory filings
• Implementation of validation studies for sterilisation and other equipment/processes- keeping in mind the data will be part of a submission
• Exploring sterile process validation requirements in submissions
 

14:50 Afternoon Tea

15:30 Implementing rapid microbiology methods

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute

• Overview of optical rapid microbial methods
• Exploring implementation objectives
• In-line integrating results

 

 

16:10 Chairman's Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Phil Duncanson

Phil Duncanson, Director, QC Microbiology, MedImmune

9:10 Mould contamination in pharmaceutical drug products

Phil Duncanson

Phil Duncanson, Director, QC Microbiology, MedImmune

• Facility design and mould remediation recovery
• Examine microbial testing conducted in the pharmaceutical industry directed towards the detection, enumeration and the identification and lifecycle of fungi
• Discuss product recalls associated with fungal contamination
 

9:50 DNA-sequencing based methods: Is it really possible to use them for a rapid, efficient and routine-based microbial identification in pharmaceutical industry?

Sara Gamberini

Sara Gamberini, Molecular Biology Scientist, Merck Serono - RBM

• Share in the development of a validated, accurate DNA method to identify bacteria, mycoplasma, fungi and moulds at genus and species level
• Learn about the improvements that made the method GMP compliant and extensively used for identification of microbial samples coming from biotechnological manufacturing environments and processes
• Discover the innovative system for transport of samples coming from the different production sites
• Hear how a very high analysis throughput has been obtained by implementing a completely automated platform for its execution
 

10:30 Morning Coffee

11:00 Latest technologies to combat and prevent water contamination and mould contamination

Brian Hubka

Brian Hubka, CEO, BGH International

  • Ensuring all water is continuously within specifications. Removing biofilms and depyrogenate
  • Benefits of 24/7 continuous monitoring
  • Easily retrofit any existing water systems
  • Case studies on why mold keeps appearing despite continuous cleaning
  •  

    11:40 Supplier Education: From pitfalls to reliable quality

    Hans Noordergraaf

    Hans Noordergraaf, Microbiologist, Abbott Biologicals

    • Case presentation of a sterility failure in purchased media
    • What is the role of the microbiologist in the process?
    • Audit process and CAPA plan as an educational tool
    • Effectiveness monitoring of executed CAPA plan

    12:20 Networking Lunch

    13:20 Endotoxin detection in biopharmaceuticals

    Wolfgang Mutter

    Wolfgang Mutter, General Manager, Hyglos GmbH

    • Regulatory requirements regarding stability of endotoxin during product shelf-life
    • Reliable test procedures for in-process control and product release 
    • Influence of major formulation components on endotoxin detectability
    • Theory of LER and recovering of masked endotoxin
     

    14:00 Afternoon Tea

    14:40 Bioburden control, cleaning and disinfection

    Jim Polarine

    Jim Polarine, Technical Service Manager, Steris Corporation

    • Case studies on bioburden control
    • Solutions for controlling fungal and bacterial spore outbreaks
    • Latest advances in cleaning and disinfection
    • Current industry regulations on bioburden control
     

    15:20 Chairman’s Closing Remarks and Close of Day Two

    Phil Duncanson

    Phil Duncanson, Director, QC Microbiology, MedImmune

    +

    FEATURED SPEAKERS

    Hans Noordergraaf

    Hans Noordergraaf

    Microbiologist, Abbott Biologicals
    Phil Duncanson

    Phil Duncanson

    Director, QC Microbiology, MedImmune
    Sara Gamberini

    Sara Gamberini

    Molecular Biology Scientist, Merck Serono - RBM
    Tim Eaton

    Tim Eaton

    Sterile Manufacturing Specialist, AstraZeneca PLC

    Andrew Bartko

    Research Leader, Battelle Memorial Institute
    Andrew Bartko

    Brian Hubka

    CEO, BGH International
    Brian Hubka

    Hans Noordergraaf

    Microbiologist, Abbott Biologicals
    Hans Noordergraaf

    Jeanne Moldenhauer

    Vice President, Excellent Pharma Consulting Inc
    Jeanne Moldenhauer

    Jim Polarine

    Technical Service Manager, Steris Corporation
    Jim Polarine

    Olivier Chancel

    Sterility and Aseptic Process Assurance Expert , Merial Sas
    Olivier Chancel

    Phil Duncanson

    Director, QC Microbiology, MedImmune
    Phil Duncanson

    Robert Neri

    Senior Scientist, Sanofi
    Robert Neri

    Sara Gamberini

    Molecular Biology Scientist, Merck Serono - RBM
    Sara Gamberini

    Stephen Rawling

    Microbiology Team Leader, GlaxoSmithKline
    Stephen Rawling

    Stijn Seels

    Process Engineer Microbiology, Genzyme
    Stijn  Seels

    Tim Eaton

    Sterile Manufacturing Specialist, AstraZeneca PLC
    Tim Eaton

    Wolfgang Mutter

    General Manager, Hyglos GmbH
    Wolfgang Mutter

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Methods for Endotoxin Detection and Removal
    Workshop

    Methods for Endotoxin Detection and Removal

    Marriott Regents Park
    20th January 2015
    London, United Kingdom

    Setting Up an Environmental Monitoring Programme to Meet Global Requirements
    Workshop

    Setting Up an Environmental Monitoring Programme to Meet Global Requirements

    Marriott Regents Park
    20th January 2015
    London, United Kingdom

    Interview with MedImmune

    Download

    Sponsors and Exhibitors


    Hyglos

    Sponsors and Exhibitors
    http://www.hyglos.com

    Hyglos is dedicated to innovation in Endotoxin Detection & Endotoxin Removal. Based on recombinant reagents, our methods are entirely animal-free without using Horseshoe crabs. The results generated with EndoLISA®, EndoZyme® and Endo-RS® convince customers from biopharmaceutical research and industry, overcoming limitations of currently used methods, including Low Endotoxin Recovery (LER).


    STERIS

    Sponsors and Exhibitors
    http://www.sterislifesciences.com

    For over 100 years STERIS Corporation has been known as a global leader, trusted partner and solutions provider in the field of sterilization and contamination control. From Formulated Chemistries, to Capital Equipment to Parts and Services, STERIS Life Sciences is Science and Solutions for Life.


    Veltek Associates Inc

    Sponsors and Exhibitors
    www.sterile.com

    Veltek Associates Inc. plays an innovative role to the pharmaceutical, biotechnology and medical device industries by developing products and services to improve operations and reduced costs associated with contamination. VAI offers a range of disinfectants, sporicides, cleaners, lubricants, environmental monitoring equipment, process cleaners, Core2Clean systems, laboratory testing and consulting services.

    Media Partners


    BioMed Central – BMC Pharmacology and Toxicology

    Official Media Partner
    http://www.biomedcentral.com/bmcpharmacoltoxicol

    BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials.


    BioMed Central – Microbiome

    Official Media Partner
    http://www.microbiomejournal.com/

    Microbiome aims to unite investigators conducting microbiome research in environmental, agricultural, and biomedical arenas. Topics broadly addressing the study of microbial communities, such as, microbial surveys, bioinformatics, meta-omics approaches and community/host interaction modeling will be considered for publication.


    BioMed Central – Annals of Clinical Microbiology and antimicrobials

    Official Media Partner
    http://www.ann-clinmicrob.com/

    Annals of Clinical Microbiology and Antimicrobials is an open access, peer-reviewed journal focusing on information concerning clinical microbiology, infectious diseases and antimicrobials. The journal aims to improve the communication between basic and clinical science in the field of clinical microbiology and antimicrobial treatment.


    BioMed Central – BMC Microbiology

    Official Media Partner
    http://www.biomedcentral.com/bmcmicrobiol

    BMC Microbiology is an open access, peer-reviewed journal that considers articles on analytical and functional studies of prokaryotic and eukaryotic microorganisms, viruses and small parasites, as well as host and therapeutic responses to them and their interaction with the environment.


    EPM

    Official Media Partner
    http://www.rapidnews.com/epm-magazine.html

    EPM is a highly regarded brand covering the pharmaceutical manufacturing supply chain from conception to production, keeping readers informed of the latest news, opinions, developments and breakthroughs in this innovative and technologically advanced sector. EPM delivers timely, topical content giving pharmaceutical manufacturers the tools they need to maximise on opportunities of growth.


    European Pharmaceutical Review

    Official Media Partner
    http://www.europeanpharmaceuticalreview.com

    European Pharmaceutical Review is the leading bi-monthly technical journal for the pharmaceutical industry, and essential reading for anyone involved in drug discovery or manufacturing. Every issue offers a high level of technical and business contributions from the world's leading pharmaceutical companies and academic institutions, keeping readers up-to-date with new developments and projects within the dynamic European pharmaceutical environment and featuring articles on topics that impact the sector, including: – cellular imaging, drug discovery, microbiology, stem cells and toxicology. The strength of European Pharmaceutical Review is reflected by our circulation figures, with an estimated 30,000 readers across the globe.


    Journal of Infection Prevention

    Official Media Partner
    http://jip.sagepub.com

    Journal of Infection Prevention aims to advance evidence based infection prevention and control, and to provide a publishing platform for all health professionals interested in this field of practice. The bi-monthly journal is peer-reviewed and contains a wide range of articles. Find out more online: http://jip.sagepub.com Journal of Infection Prevention is published by SAGE Publications.


    Global Biodefense

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    Global Biodefense publishes the latest news on vaccine and therapeutics countermeasure development, biosurveillance and detection technologies, food safety and biosecurity, and CBRN incident preparedness and response. Visit our website to access daily news updates, organization profiles, conference listings, and the latest in funding opportunities for advancing biodefense technology.

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    Labhoo

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    Scrip Intelligence

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    KONGPOSH Publications

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    KONGPOSH Publications is one of India’s leading Pharma Publishers. The Pharma Review® is a bi-monthly article based journal covering various fields of pharmacy. Participation and distribution in over 30 Expos & Conferences worldwide each year. It is widely read by decision makers, middle management and the academia. Also available in E-book format. Other publications : Indian Pharma Reference Guide (Annual) – Names and address of Pharmaceuticals, Bulk Drugs, Machinery’s & Instrumentation, AYUSH Manufacturers; and much more; High Performance Thin Layer Chromatography; Elements of Pharmacovigilance; Regulation of Clinical Trials; AYUSH (CD); NDDS/AMD (CD)


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    Technology Networks

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    Absave

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    American Pharmaceutical Review

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    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. We are an online R&D matching tool that connects Scientifics and organizations involved in discovery, development and delivery of new healthcare products with service and products providers worldwide. Life science information technology is undergoing a revolution. Part of that revolution involves new, unexplored business models, open innovation, open data and collaboration. If you have a project or idea that you would like to propose, develop or run, we can help. A New Collaboration Network Model for Discovery Research and Development • Effective Platform: the 95% • 5.000 registered users // > 15.000 Newsletter subscribers • Geographical background: 45,5% Europe / 37,5% North America / 16,5% Asia / 0,5% ROW • Professional background: Outsourcing Manager, Project Manager, CEO, Business Developer, CSO, Account Manager, Sales & Marketing People, Scientists, R&D. For further information, please visit our website www.contract-biotechnology.com


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    BioMed Central – Journal of Pharmaceutical Policy & Practice

    Supporters
    http://www.joppp.org/

    Journal of Pharmaceutical Policy and Practice (formerly known as Southern Med Review) is an open access, peer-reviewed journal. It provides a platform for researchers to disseminate empirical research findings, with the aim that people everywhere have access to the medicines they need and use them rationally.


    Pharma Technology Focus

    Supporters
    http://www.nridigital.com/

    Pharma Technology Focus Magazine is a dynamic bi-monthly online publication available on iPad and online. It offers in-depth coverage of the most important issues and the latest developments in the pharmaceutical industry, in an innovative digital format. Brought to you by an experienced editorial and design team, Pharma Technology Focus is the essential magazine for decision-makers wanting up-to-date pharmaceutical industry news and analysis, with articles and features covering technology, discovery and development, packaging and labelling, supply chains, manufacturing and ingredients, trials and successes and much more.

    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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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