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SMi are proud to announce the launch of their inaugural conference on Pharmaceutical Microbiology.

Microbiological contamination of products and processes in a lab and manufacturing environment continues to be a major problem to the Pharmaceutical and Biotechnological industries and its regulators. The potential impact of such contamination can be enormous, and does not only create health and safety problems but can also cost companies millions in lost product revenue. 

Put simply, microbial contamination can kill patients and business!

This conference aims to address; the latest developments and procedures used in the identification and prevention of contaminating agents; the design and validation of new lab environments; sterile manufacture and process validation; the challenges facing the Pharmaceutical Microbiology industry; and updates on new rules and regulations.
 

“Contamination of an aseptic process can have a serious impact on a company’s financial viability, manufacturing license and industry reputation. Regulatory GMP codes for the aseptic manufacture of human and veterinary products mandates that an incidence involving product sterility failure or media fill contamination must be fully investigated, and also that the manufacturer establishes an environmental monitoring program that is properly validated to ensure that any environmental contaminates are detected.”

Business Biotics Group

View the conference programme    

 Register for the event

     Download the brochure

 

Key topics under discussion include;

  • 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

 

You should attend this event if you are involved in;
  • Microbiology

  • 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

 

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Tim Sandle

Tim Sandle, Head of Microbiology, Bio Products Laboratory (BPL)

9:10 BEST PRACTICES FOR AN ENVIRONMENTAL MONITORING PROGRAM QUALIFICATION

Luis Mayor

Luis Mayor, QC Microbiologist, Genentech

  • Determination of number of sites
  • Sample site selection
  • Microbial identification significance during EM qualification
  • 9:50 THE USE OF RISK ASSESSMENT IN THE PHARMACEUTICAL INDUSTRY - THE APPLICATION OF FMEA TO A STERILITY TESTING ISOLATOR: A CASE STUDY

    Tim Sandle

    Tim Sandle, Head of Microbiology, Bio Products Laboratory (BPL)

  • Overview of risk assessment tools used in the pharmaceutical industry
  • Introduction to Failure Modes and Effects Analysis (FMEA)
  • FMEA case study: sterility testing isolator
  • Risks to isolators
  • Preventative measures
  • 10:30 Morning Coffee

    11:00 SOLUTIONS FOR ADDRESSING BACTERIAL SPORE AND MOLD SPORE EXCURSIONS IN PHARMACEUTICAL AND BIOTECH OPERATIONS

    Jim Polarine

    Jim Polarine, Technical Services Specialist, STERIS Corporation

  • The industry is facing an increase in the number and species of bacterial endospores and mold spores found in facilities
  • Sporicidal products and data
  • Addressing bacterial spore issues and ways to limit bacterial and mold spore contamination
  • Current industry regulation in the US and Europe
  • Personnel practices, incoming items into cleanrooms, facility design and conditions, and products used
  • 11:40 RECENT ISSUES AND OBSERVATIONS DURING EU GMP INSPECTIONS

    Des Makohon

    Des Makohon, Senior GMP Inspector, MHRA

  • Issues regarding micro labs and results
  • Common GMP failing points
  • Overlooked regulations
  • 12:20 Networking Lunch

    13:20 STERILITY FAILURE: WHAT HAPPENS NEXT?

    Neil Raw

    Neil Raw, GMP Inspector, MHRA

  • Re-tracing steps- What went wrong?
  • Suitable investigation procedures
  • Developing an appropriate SOP
  • 14:00 NEW GENERATION OF NEUTRALISING CULTURE MEDIA FOR SURFACE DISINFECTANTS

    Arnaud Paris

    Arnaud Paris, Global Marketing Director, Biopharma, BioMerieux

  • Review of classical disinfectants used in pharma
  • Optimization of culture media formulation
  • Performance evaluation on two specific disinfectants
  • 14:40 Afternoon Tea

    15:10 BEST PRACTICES FOR PERFORMING CONTAMINATION INVESTIGATIONS

    Francesco Boschi

    Francesco Boschi, QC Microbiology Manager, Patheon

  • Assessing contamination data accuracy
  • Key factors for carrying out an effective and quick investigation: development of a check-list
  • Planning a feasible corrective/preventive actions (CAPA) plan
  • Follow-up: When an investigation is really completed?
  • 15:50 RISK MANAGEMENT OF CONTAMINATION DURING CLEANROOM OPERATIONS

    Tim Eaton

    Tim Eaton, Sterile Manufacturing Specialist, Astrazeneca

  • Fundamental mechanism of contamination transfer
  • Sources of contamination (particularly humans)
  • Routes of transfer and risk diagrams
  • General cleanroom risk assessments and quantification of risk
  • Management of risk
  • 16:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Amy McDaniel

    Amy McDaniel, Director, QC Microbiology, Pfizer

    9:10 SUSTAINING A LEAN QC MICROBIOLOGY LABORATORY

    Amy McDaniel

    Amy McDaniel, Director, QC Microbiology, Pfizer

  • Challenges that were encountered moving from implementation to sustainability
  • Tools for sustaining lean product testing and environmental monitoring
  • Key performance indicators for the QC microbiology laboratory
  • 9:50 THE TRAVELLING MICROBIOLOGIST - EXPERIENCES FROM API AUDITING

    Philip Greaves

    Philip Greaves, Operations Director, Bovis Lend Lease

  • Experiences from field audits
  • Microbiological risks identified
  • Making quality improvements
  • Managing multiple audits
  • 10:30 Morning Coffee

    11:00 5S LEAN LAB IMPLEMENTATION

    Louis Egger

    Louis Egger, Sterilization and Microbiology Manager, Johnson & Johnson

  • Developing an effective 5S plan
  • A case study
  • Evaluating the 5S success
  • 11:40 THE MANUFACTURING PLANT MICROBIOLOGIST – BREAKING BARRIERS AND BUILDING RELATIONSHIPS

    Scott Smith

    Scott Smith, Microbiology QC leader, Sanofi-Aventis

  • Earning respect of operation teams and building confidence
  • Unlocking data and sharing process understanding
  • Assuring competence
  • 12:20 Networking Lunch

    13:40 CELSIS RAPID DETECTION

    Anna Mills

    Anna Mills, Technical Support Manager, Celsis

  • Rapid microbial limits and sterility testing using Adenylate Kinase (AK)-amplified bioluminescence
  • Overview of Celsis technology and the theory behind bioluminescence
  • The application of amplified bioluminescence to both microbial limits testing and sterility testing
  • 14:20 VALIDATION CONSIDERATIONS WHEN IMPLEMENTING A RAPID MYCOPLASMA TEST

    John Duguid

    John Duguid, Principal Process Analytical Scientist, Genzyme

  • Selecting mycoplasma test methodology
  • Choosing validation parameters based on compendial guidance
  • Avoiding validation pitfalls specific to mycoplasma
  • 15:00 A RISK-BASED APPROACH FOR DETERMINING OBJECTIONABLE MICROORGANISMS IN NON-STERILE PHARMACEUTICAL PRODUCTS

    Rhonda Ezell

    Rhonda Ezell, Micro Lab Manager, Qualitest Pharmaceuticals

  • Guidelines and regulations for objectionable microorganisms
  • Who should be involved in determining whether an organism is objectionable
  • How to determine whether a microorganism is objectionable through scientific risk-based assessments
  • 15:40 Chairman’s Closing Remarks

    15:50 Afternoon Tea and Close of Conference

    +

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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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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