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SMi’s 10th Annual Conference
Pharmaceutical Microbiology UK
January 18 - 19, 2021 | London, United Kingdom

Pharmaceutical Microbiology as an industry is projected to see significant advancements in the next five years. This forecast is largely attributed to rapid microbiology testing, which has accounted for $3.5 billion last year, while projected to reach nearly double at $6 billion by 2025, and an estimated CAGR of 8.3% leading up to 2025.

At the very core of pharmaceutical microbiology is the accurate and reliable detection of microorganisms that would otherwise contaminate the pharmaceutical products manufactured. This demand for more rapid methods for detection and identification will be addressed alongside equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing effective strategies to meet updated regulatory requirements.

Join us at SMi’s 10th Annual Pharmaceutical Microbiology Conference to explore the newest case studies and latest technologies that tackle the most pressing challenges and are pushing innovation in world of pharmaceutical microbiology.

 

• INSIGHT into the complex regulatory landscape and extensive regulator expectations
• EXPLORE the latest advancements in environmental monitoring technology and strategy
• DELVE into contemporary case studies delivered by experts in agile contamination control
• ATTAIN expert tuition in environmental monitoring at the post-conference workshop day 
 

• Heads of Aseptic Processing
• Heads of Microbiology
• Global Quality Directors
• Heads of GMP Compliance
• Quality & Compliance Heads
• Microbiology Senior Specialists
• Heads of Site Compliance
• Heads of Sterile Technology
• Global Microbiology Analytical Experts
• Directors of Quality Control Biology

• 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.;

FEATURED SPEAKERS

Di Morris

Di Morris

Senior Manager, Team Leader, GSK
Helen Gates

Helen Gates

Global Technical Consultant, Ecolab
Ian Ramsay

Ian Ramsay

Independent Quality Consultant, RamsayPharma
James Drinkwater

James Drinkwater

PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
Jim Polarine Jr

Jim Polarine Jr

Senior Global Technical Service Manager, Steris Corporation
Johannes Oberdoerfer

Johannes Oberdoerfer

Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
Juliana Nassette

Juliana Nassette

Team Lead QC Microbiology, Kite Pharma
Ramond Benoit

Ramond Benoit

Head of Microbiology & Sterile Technology, Sanofi

Di Morris

Senior Manager, Team Leader, GSK
Di Morris

Di is qualified with MRSC Chemistry and Post Graduate Diploma Industrial Pharmaceutical Science and is a Qualified Person under permanent provisions since 1993.
Di has worked in the pharmaceutical industry for over 40 years this includes a number of years as a Medicines Inspector for the MHRA. Di has worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance, Regulatory Affairs and Compliance Auditing and has worked with a wide range of dosage forms including sterile products, biological, and non-sterile dosage forms.
 

Helen Gates

Global Technical Consultant, Ecolab
Helen Gates

Helen Gates is a Microbiologist with more than fifteen years’ experience within the Pharmaceutical Industry, holding roles within Microbiology, Quality and Production, supporting the manufacture of sterile and non-sterile active pharmaceutical ingredients. Helen acted as the subject matter expert for topics including contamination control, environmental monitoring, aseptic process and equipment validation and water systems.

Helen joined Ecolab in 2019 as a Global Technical Consultant for Ecolab Life Sciences, advising on application and use of specialist cleanroom biocides in line with current regulatory guidance and industry best practice.
 

Henrietta Vinneras

Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Henrietta Vinneras

Mrs Vinnerås has been in the industry since year 2000 and has worked for pharmaceutical and medical device companies such as Pfizer, Abbott, GE Healthcare, Thermo Fisher Scientific and currently at Fresenius Kabi. Mrs Vinnerås is part of a global competence center supporting mainly the companys’ pharmaceutical manufacturing, medical devices and compounding centers world-wide with e.g. establishing global corporate procedures, on-site assessments, education and training, trouble shooting, root cause investigations, CAPAs and continuous improvement projects; specifically within the areas of microbiology and aseptic technique. She is also a member of the PDA Journal of Pharmaceutical Sciences and Technology editorial board.

Ian Ramsay

Independent Quality Consultant, RamsayPharma
Ian Ramsay

He has a Degree in Microbiology and joined the industry in 2004, with GlaxoSmithKline where he spent 8 years in a number of roles within QC and QA. He spent significant time within front line QA roles supporting a range of different products and dose forms- including steriles, non-steriles, tablets, capsules, topicals, injectables, inhaled products and biologics. This role culminated in a global QA function where Ian spent 2 years supporting inspection readiness and providing oversite for multiple vaccine manufacturing sites worldwide.

After spending time in industry, Ian spent 4 years as an MHRA GMDP inspector. This role saw Ian responsible for planning and executing inspections worldwide across a wide range of products and dose forms. In this time, Ian specialised in data integrity and unlicensed aseptic operations. Ian also spent significant time managing serious non-compliance cases through the formal regulatory process (IAG) and is experienced in site remediation activities.

As a consultant, Ian has assisted multiple companies worldwide across a diverse range of dose forms. RamsayPharma offers comprehensive support in the areas of consulting, audit and remediation.

James Drinkwater

PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
James Drinkwater

F Ziel Head of GMP Compliance and Aseptic process integration. 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.

Jim Polarine Jr

Senior Global Technical Service Manager, Steris Corporation
Jim Polarine Jr

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 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.

Johannes Oberdoerfer

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

The pharmaceutical company Boehringer Ingelheim was founded in 1885 by Albert Boehringer in Ingelheim am Rhein. From its beginnings in 1885 the company has since become a global enterprise with more than 50 000 employees.
Boehringer Ingelheim BioXcellence™ is a world-leading biopharmaceutical contract manufacturer with tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof.
The Endotoxin testing lab has the challenge of managing and testing a large number of water samples on a daily basis, making it necessary for microbiology lab analysts to perform water endotoxin/LAL testing. The Endosafe® Nexus™ robotic endotoxin/LAL testing system combines a proven cartridge-based LAL technology (the multi-cartridge system, or MCS™) with a robotic system that carries and dilutes samples all the way through to completion. The Endosafe® Nexus™ system increases the laboratory throughput and efficiency while reducing potential pipetting variability and data entry errors with its sample bar code reader and ability to communicate with Labware LIMS.
 

Juliana Nassette

Team Lead QC Microbiology, Kite Pharma
Juliana Nassette

I have finished my bachelor degree and post- graduation in Biomedical Sciences specializing myself in Microbiology at the Jean Piaget University in Portugal.
In 2010 I have moved to The Netherlands where I worked at Crucell B.V., today know as J&J Janssen Vaccines for a bit over 3 years and got introduced to Environmental Monitoring and contamination control.
After that I have spent roughly 5 years in R&D at 2 different companies still in the area of contamination control but got more in depth with biocidal products for disinfection and preservation of materials.
End of 2019 I have joined Kite Pharma and got back to my origins in the pharmaceutical industry, where I became the Team Lead of the Microbiology department where part of the responsibilities are the strategy around Environmental Control and Monitoring.
 

Ramond Benoit

Head of Microbiology & Sterile Technology, Sanofi
Ramond Benoit

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

Tony Cundell

Principal Consultant, Microbiological Consulting, LLC
Tony Cundell

Dr. Tony Cundell consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

He is a member of the 2020-2025 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods, co-chairing the USP Expert Panel that published a stimuli article in the Sept-Oct. 2017 Pharmacopeial Forum entitled The Development of Compendial Rapid Sterility Tests.

Tony Cundell chaired the PDA task force responsible for the ground-breaking 2000 Technical Report No. 33 The Development, Validation, and Implementation of New (Rapid) Microbiological Methods. In June 2009, he co-edited with Anthony Fontana a book entitled Water Activity Applications in the Pharmaceutical Industry and contributed two chapters to the book. He was co-chair of the PDA task force responsible for 2014 Technical Report No. 67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. In 2015 he was appointed to the Advisory Committee of Sterile Compounding to the State of Massachusetts Board of Pharmacy. He received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to the advancement of pharmaceutical science.

More recently Tony Cundell co-authored a review article entitled Controls To Minimize Disruption of the Pharmaceutical Supply Chain During the Covid-19 Pandemic that was published in the July-August, 2020 issue of the PDA J. Pharm. Sci. & Technol.
 

Sponsors and Exhibitors

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 and Exhibitors


Ecolab

Sponsors and Exhibitors
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.


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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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