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SMi’s 10th Annual Conference
Pharmaceutical Microbiology UK
January 17 - 18, 2022 | London, UK
Microbiology remains an essential tool for the detection of microorganisms present in biopharmaceutical and pharmaceutical batches.
In recent years, the industry’s interest in microbiology has grown, this has been in part due to the growing resistance of certain bacteria to antibiotics, as well as the introduction of new technologies and automated solutions which provide more rapid results for faster clinical decisions -- making the most relevant information easily accessible to clinicians, significantly improving the operational efficiency of laboratories. Microbiological considerations continue to be one of the largest areas of investment from the pharmaceutical industry.

This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and minimisation of operator intervention, to the latest technologies in rapid microbiological testing methods and data integrity.

To register your interest or to get involved please contact: eshambler@smi-online.co.uk


This workshop will focus in on key elements of an effective Contamination Control Strategy (CCS). Specifically cleaning and disinfection, personnel and environmental monitoring, risk training and outsourcing training will be covered. Annex I and PDA Technical Report # 70 provide guidance on risk and cleaning and disinfection which will be discussed. Several case studies will also be detailed utilizing fishbone diagrams and the 5 whys for analysis. The importance of all measures in the CCS are to minimize microbial, particulate and pyrogen contamination risks including the implementation of an appropriate monitoring for its success.

• Case studies will be presented utilizing risk assessment tools.
• Attendees will learn how to develop a successful and comprehensive CCS.
• Strategies for an effective cleaning and disinfection program will be covered.
• Environmental monitoring and personnel sampling will be discussed.
• Outsourcing training and implantation will be covered.


  • Heads of Aseptic Processing
  • Heads of Microbiology
  • Global Quality Directors
  • Heads of GMP Compliance
  • Quality & Compliance Heads
  • Microbiology Senior Specialists
  • Directors of Quality Control Biology
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Heads of Site Compliance
  • Heads of Sterile Technology
  • Global Microbiology Analytical Experts
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
  • Previous attendees include:


Allergy Therapeutics Ltd; AllergyTherapeutics; Associates of Cape Cod; Associates Of Cape Cod International; AstraZeneca; AstraZeneca PLC; Baxter; Baxter Healthcare Ltd; BioMerieux; bioMerieux UK Limited; BioPhorum; Boehringer Ingelheim; Boehringer Ingelheim Pharma GmbH & Co. KG; Charles River EMD; Christian Doppler Laboratory for Monitoring of Contaminants, University of Veterinary Medicine, Vienna; Copan; Copan Group; Copan Italia SpA; CTL - Mat; David P Elder Consultancy; European Patent Office; Fagron; Freeline; Fresenius Kabi; Fresenius Kabi UK Ltd; GSK; GSK Vaccines; GW Pharma ; King's College London ; Kite Pharma ; Lonza; MeiraGTx; Meriagtx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; MIcrobiologics; Microgenetics Ltd; Novo Nordisk; Oxford Biomedica Ltd; Paul Ehrlich Institut; PHSS: Pharmaceutical & Healthcare Sciences Society; Reading Scientific Services Ltd; Reading Scientific Services Ltd (RSSL); Regeneron Pharmaceuticals Inc.; RSSL; Sanofi-Aventis Deutschland GmbH; SDA Pharma; Steris Corporation; Techniconsult Firenze SRL; University of Veterinary Medicine Vienna; VCCN/Brookhuis Applied Data Intelligence; Veltek Associates, Inc.;


Workshop programme

8:30 Registration & Coffee

9:00 Introductions and Workshop Overview

  • The importance of CCS in minimizing microbial, particulate, and pyrogen contamination risks
  • Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    Benoit Ramond

    Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi
    View Bio

    9:15 Contamination Control

  • Risk Based Analysis
  • Case studies in utilizing risk assessment
  • Environmental Monitoring
  • Developing a successful and comprehensive CCS
  • Outsourcing Training, covering implantation
  • Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    Benoit Ramond

    Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi
    View Bio

    10:15 Coffee Break

    10:45 Cleaning and Disinfection Case Studies

  • Fungal and Bacterial Spore Case Studies
  • Cleaning and Disinfection Case Studies
  • Effective program strategy
  • Recent FDA Warning Letters and 483’s
  • Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    Benoit Ramond

    Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi
    View Bio

    12:00 Questions and Answers

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    Benoit Ramond

    Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi
    View Bio

    12:15 End of Workshop



    Benoit Ramond

    Benoit Ramond

    Head of Microbiology & Sterile Technology, Sanofi
    Jim Polarine

    Jim Polarine

    Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi

    Benoit Ramond

    Head of Microbiology & Sterile Technology, Sanofi
    Benoit Ramond

    Benoît Ramond is Doctor in Pharmacy at the University of Paris XI in France and obtains a PhD in Microbiology.
    He has more than 30 years of experiences in the Pharmaceutical Industry.
    Since 2016 he is Head of Microbiology and Sterile Technology Expertise in Sanofi Group. In his function he has also a leading role in the Annex 1 implementation program within Sanofi.

    Jim Polarine

    Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    Jim Polarine

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.



    Venue To Be Confirmed

    London, United Kingdom

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.


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    United Kingdom

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    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.


    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.


    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.


    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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