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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

The revision of EU GMP annex1 for manufacture of sterile products requires the preparation of a Contamination Control Strategy (CCS) that must follow QRM (Quality risk management principles. In association if the sterile products are hazardous or require cross contamination control containment with aseptic processing is required and the approach needs defining in an Aseptic-containment strategy (ACS). This workshop covers the key considerations in preparing a CCS & ACS using a case study of filling an ATMP viral vector that is part of a CarT cell cancer therapy to show implementation.

  • The preparation of a CCS requires a multi-functional group, and the workshop should be of value of all those involved in sterile product manufacturing. Typically, CCS preparation is led by Quality Assurance groups in association with site microbiologists
  • Key considerations on contamination routes and vectors in a sterile product manufacturing supply chain and facility
  • Contamination risks mitigations and control measures considered for a CCS
  • Case study application of a CCS for an ATMP product formulation and filling process
  • Considerations for an Aseptic-Containment strategy for cross contamination control and viral vector containment


  • 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

13:30 Registration & Coffee

14:00 Opening Remarks and introductions

James Drinkwater

James Drinkwater, Head of GMP Compliance, F Ziel GmbH and PHSS
View Bio

Holger Kranenburg

Holger Kranenburg , Senior Scientist GMP Compliance, F Ziel GmbH and PHSS

14:10 Key requirements and expectations of a CCS and ACS to meet Annex 1 and Chapters 3 & 5 of GMPs, considering cross contamination control

  • Overview of PHSS-A3P CCS Guidance: Principles, content, structure
  • CCS Scope and positioning in site, regulatory documentation structure.
  • Contamination control Risk identification, Risk assessment and Control measures as the basis of CCS preparation


  • James Drinkwater

    James Drinkwater, Head of GMP Compliance, F Ziel GmbH and PHSS
    View Bio

    Holger Kranenburg

    Holger Kranenburg , Senior Scientist GMP Compliance, F Ziel GmbH and PHSS

    14:50 Contamination risk control measures Gap analysis in CCS preparation

  • Annex 1 compliance Gap analysis
  • Facility and Process design meeting GMP requirements and expectations to be documented in a CCS – leveraging existing documents.
  • James Drinkwater

    James Drinkwater, Head of GMP Compliance, F Ziel GmbH and PHSS
    View Bio

    Holger Kranenburg

    Holger Kranenburg , Senior Scientist GMP Compliance, F Ziel GmbH and PHSS

    15:30 Afternoon Tea

    16:00 Case study application of a CCS/ ACS for an ATMP product formulation and filling process

  • Facility designs and process maps to be used in CCS/ACS preparation
  • Content of CCS Case study: Overview
  • Connecting contamination control and cross contamination control through CCS and ACS including viral containment strategy
  • James Drinkwater

    James Drinkwater, Head of GMP Compliance, F Ziel GmbH and PHSS
    View Bio

    Holger Kranenburg

    Holger Kranenburg , Senior Scientist GMP Compliance, F Ziel GmbH and PHSS

    17:00 Closing remarks & End of workshop

    James Drinkwater

    James Drinkwater, Head of GMP Compliance, F Ziel GmbH and PHSS
    View Bio

    Holger Kranenburg

    Holger Kranenburg , Senior Scientist GMP Compliance, F Ziel GmbH and PHSS



    Holger Kranenburg

    Holger Kranenburg

    Senior Scientist GMP Compliance, F Ziel GmbH and PHSS
    James Drinkwater

    James Drinkwater

    Head of GMP Compliance, F Ziel GmbH and PHSS

    Holger Kranenburg

    Senior Scientist GMP Compliance, F Ziel GmbH and PHSS
    Holger Kranenburg

    James Drinkwater

    Head of GMP Compliance, F Ziel GmbH and PHSS
    James Drinkwater

    James is also an honorary member of the Not-for Profit Pharmaceutical and Healthcare Sciences Society: PHSS, Leading the PHSS Aseptic processing and Bio-contamination special interest groups and Annex 1 Focus group. James is pharmaceutical process engineer with additional education in Pharmaceutical microbiology with a career spanning over 35 years in Pharmaceutical manufacturing and Aseptic processing technologies. Additional association memberships include the Pharmaceutical Quality Group (PQG) UK and ISPE.


    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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    Venue To Be Confirmed

    United Kingdom

    Venue To Be Confirmed



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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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