Home
overview

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
 

  • DISCOVER case studies in Contamination Control Strategy and Container Closure Integrity with leaders in the pharmaceutical industry
  • GAIN insight the regulatory strategy and latest regulator focus for successful and robust audits
  • EXPLORE the new best practice and EU GMP guidelines in risk-based cleaning, microbial detection, and operator intervention
  • JOIN the panel discussion on modern, rapid microbiological testing methods and their application in advanced therapeutics 
  • DISCUSS the latest developments in the detailed, rapid detection of microbes in pharmaceutical water

 

 

  • 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.;
 

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Di Morris

Di Morris, Clinical Auditor, AstraZeneca

9:10 Real-Time Viable Air Particle Counting: Technology and Validation

Peter Annel

Peter Annel, Principal Scientist, Novo Nordisk A/S

• The principles of real-time counts of total and viable particles in pharmaceutical manufacturing environments:
        o Minimising aseptic interventions, streamlining investigations, and improving knowledge of the process
• Showcasing the monitoring technology and equipment
• Methodology behind the validation approach
 

9:50 Validation of a real-time PCR-based Rodent Parvovirus Detection Assay

Sven Deutschmann

Sven Deutschmann, Head of Global ASAT, Global QC, Roche Diagnostics GmbH

• Background of Rodent Parvovirus Testing
• Development of a Rodent Parvovirus real time-PCR Assay
• Method Validation
 

10:30 Morning Coffee

11:00 How a next generation approach to data can help you maintain control

Andrew Davies

Andrew Davies, Microgenetics Managing Director, Microgenetics Ltd

• What is Pharma 4.0 and key benefits
• Issues in digitalising the pharmaceutical industry: from regulation to “we’ve always done it this way” attitudes
• Benefits of digitalisation
• Digitalisation of environmental monitoring data and how this allows you to get more out of it
 

11:40 Guidance on Biocontamination Control, Cleaning, and Disinfection in Pharmaceuticals

12:20 Panel Discussion: Diversity in Science: the importance of workplace diversity in life sciences

• Career negotiation tactics and best practice
• Significant challenges, biggest wins and failures
• Remote inspections
• Regulatory and clinical perspectives
• Identifying the barriers towards inclusion and diversity
• Advantages of diversity, equity, and inclusion over a homogenous workforce
 

Jim Polarine

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

Suzanne Nutter

Suzanne Nutter, QA Group Manager, AstraZeneca

Di Morris

Di Morris, Clinical Auditor, AstraZeneca

Pratixa Patel

Pratixa Patel, Senior Director, Microbiological and Stability Sciences, GSK

13:00 Networking Lunch

14:00 A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom

Jim Polarine

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

• Risk Assessment approach to fungal spore contamination in ATMP facilities
• Walking the audience through key contamination risks in the ATMP cleanroom
• Present efficacy data on disinfectants and sporicides to eliminate fungal spores in ATMP cleanroom operations
• Highlighting the latest Annex I and FDA regulations and guidance documents related to contamination control in ATMP operations
 

14:40 Sanofi Pasteur Mycoplasma techno roadmap and implementation of mycoplasma alternative method to release human vaccines

Thierry Bonnevay

Thierry Bonnevay, Microbiological Analytical Expert, Sanofi Pasteur

• Regulatory background and Mycoplasma testing
• Development of NAT methods
• Validation of NAT method for Mycoplasma testing
• Roadmap and Implementation for new vaccines and commercialized product
 

15:10 Afternoon Tea

15:50 Annex 1 and Environmental Monitoring Program - implementation and justification of the best practices in routine

Benoit Ramond

Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi

• Annex 1 - Viable and Non-viable Environmental Monitoring Program
• What is new? How to implement the changes?
• EM program and Contamination Control Strategy
• Example of Risk Analysis Methodology
• EM program and Data Management
 

16:30 Contamination Control Strategy - a wholistic way to maintain sterility assurance

Martin Mullner

Martin Mullner, Senior Quality Assurance Manager, Boehringer Ingelheim Pharma GmbH & Co. KG

• Current status of EU GMP Annex-1-
• Elements of a CCS and contaminants in scope
• CCS hierarchy, structure, and lifecycle
• Case Studies
 

17:10 Chair’s Closing Remarks and Close of Day One

Di Morris

Di Morris, Clinical Auditor, AstraZeneca

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Di Morris

Di Morris, Clinical Auditor, AstraZeneca

9:10 The necessity of Data Integrity to the Microbial Quality Control Lab

Di Morris

Di Morris, Clinical Auditor, AstraZeneca

• Harnessing accurate, relevant, and reliable data to automate processes and reduce risk
• Automating endotoxin testing to remove as much potential for human error as possible
• Removing subjectivity from testing through the use of objective and reagent-based automated software
• Error-free microbial identification to support comprehensive environmental monitoring programmes
 

9:50 From Visual Counting to Automation of Environmental Monitoring with the Growth Direct™

Johannes Oberdoerfer

Johannes Oberdoerfer, Scientist of Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG

• Build your business case to show the impact of automation in your lab
• Define your validation strategy
• The Growth Direct™ in routine
 

10:30 Morning Coffee

11:00 Developing Wipe Efficacy Validation for the Pharmaceutical Industry

David Collins

David Collins, Global Technical Consultant, Ecolab Life Sciences

• Disinfectant efficacy for end user validation is demonstrated through performance testing to show that a disinfectant is capable of reducing microbial bioburden on cleanroom surfaces to an acceptable level
• Of the different efficacy studies performed for disinfectant validation, surface studies with mechanical action (wiping) are regarded as the most challenging but most representative of actual cleanroom conditions and disinfectant application
• Use of a harmonized wipe method can give companies a transferable platform to achieve replicable results between laboratories and between countries
• Consideration of the factors discussed, including development of validation study controls, investigation of wipe material, wipe saturation and disinfectant application, will aid in the creation of a disinfectant efficacy study that will stand up to regulatory scrutiny across the globe
 

11:40 Applying virtual reality to training in aseptic processing and microbiology

• Overview of the technology
• Rollout plan and approach
• Pros and Cons of the technology for training
 

Karen Capper

Karen Capper, UK Site Microbiologist, AstraZeneca

Suzanne Nutter

Suzanne Nutter, QA Group Manager, AstraZeneca

12:20 Current state of Pyrogen- and Endotoxin Testing

Ingo Spreitzer

Ingo Spreitzer, Deputy Head of Communications and IT Department, Paul Ehrlich Institut

• Testing for Pyrogens and/or for Endotoxins?
• Monocyte Activation Test
• Recombinant Factor C and recombinant full cascade Endotoxin test
• Regulation and Resistance
 

13:00 Networking Lunch

14:00 Alternative endotoxin test methods for products exhibiting low endotoxin recovery

Ren-Yo Forng

Ren-Yo Forng, Scientific Director, Amgen

• The development of a suitable method to replace current endotoxin testing methods for products
• A strategic approach to the evaluation and validation of testing methods
• The future for finding a suitable replacement method – scope and reality check
 

14:40 Evolution of Microbiology testing

Pratixa Patel

Pratixa Patel, Senior Director, Microbiological and Stability Sciences, GSK

• Approaching to bring speed to historically slower test methods
• How to develop methods which are ‘fit for purpose’
• Risk management program: how it adds confidence to rapid testing
 

15:20 Afternoon Tea

15:50 Sustainable Lab Certification: a growing green paradigm in pharmaceutical production

Raj Patey

Raj Patey, ACT Label Consultant, My Green Lab

• Successful techniques for effective sustainability strategy implementation into pre-existing laboratory processes
• Identifying modern microbiological testing methods that synergise with sustainable practices
• How greener labs decrease operation periods and expenses, on top of ecological influence
• Strategies to integrate sustainability into research, development, and key lab operations
 

17:00 Chairman’s Closing Remarks and Close of Day Two

+

FEATURED SPEAKERS

Karen Capper

Karen Capper

UK Site Microbiologist, AstraZeneca

Andrew Davies

Microgenetics Managing Director, Microgenetics Ltd
Andrew Davies

David Collins

Global Technical Consultant, Ecolab Life Sciences
David Collins

Ingo Spreitzer

Deputy Head of Communications and IT Department, Paul Ehrlich Institut
Ingo Spreitzer

Jim Polarine

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

Johannes Oberdoerfer

Scientist of Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
Johannes Oberdoerfer

Karen Capper

UK Site Microbiologist, AstraZeneca
Karen Capper

Ren-Yo Forng

Scientific Director, Amgen
Ren-Yo Forng

Sponsors

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

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.

 

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.
HOTEL BOOKING FORM

Sponsors


Ecolab

Sponsors
https://en-uk.ecolab.com/

Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry.

Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency.



Microgenetics

Sponsors
https://microgenetics.co.uk/

Microgenetics is a biotech company specialising in microbiology, with two products currently:

• SmartControl, allowing easy capture and analysis of microbiological environmental monitoring data and is pre-validated for GMP compliance

• SwiftDetect, an ultra-sensitive rapid sterility test capable of detecting a single cell in a large sample volume in 6 hours


SAVE TO


Outlook Calendar  OUTLOOK CALENDAR
Google Calendar  GOOGLE CALENDAR
ICal Calendar  ICAL CALENDAR
Yahoo! Calendar  YAHOO! CALENDAR

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

Title

SubTitle
speaker image

Content


Title


Description

Download


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

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

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




Forgotten Password

Please enter the email address you registered with. We will email you a new password.

Thank you for visiting our event

If you would like to receive further information about our events, please fill out the information below.

By ticking above you are consenting to receive information by email from SMi.
Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out