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SMi’s 9th Annual Conference
Pharmaceutical Microbiology UK
January 20 - 21, 2020 | London, United Kingdom
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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 accompanied by equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing updates to meet regulatory requirements.
 

Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of pharmaceutical microbiology.
 

Highlights for 2020
• Discuss the regulatory expectations and supportive guidance on bio-contamination control and monitoring in aseptic manufacturing of sterile products from PHSS
• Gain valuable insight from key opinion leaders in a panel discussion on the impact of the Annex 1 revisions on pharmaceutical microbiology
• Examine the common myths and urban legends in the pharmaceutical industry related to contamination control from STERIS
• Explore container closure integrity and controls strategies ensuring product sterility from AstraZeneca
• Revisit the role of the Official Medicines Control Laboratories as the GMP back up from Infarmed IP
 

Allergan Biologics Ltd; Allergy Therapeutics; Allergy Therapeutics UK; AllergyTherapeutics; AstraZeneca; Atalmedial; Baxter Healthcare Ltd; Biomerieux; bioMerieux UK Limited; Boehringer Ingelheim; BPL; British America Tobacco; Cancer Research UK; Cell and Gene Therapy Catapult; Ceutiqus; CGT - Catapult ; CGT (Cell & Gene Therapy Catapult) ; ChargePoint Technology; Charles River; Copan Group; Copan Italia SpA; Dupont De Nemours (Luxembourg) S A; DuPont de Nemours Luxembourg sarl; Fresenius Kabi; Fresenius Kabi UK Ltd; Fujifilm Wako Chemicals USA Corp; Genzyme Geel; Greiner Bio-One; GSK; GSK Vaccines; International Serum Industry Association; Ipsen; Kings College London; Medicines & Healthcare products Regulatory Agency (MHRA); MeiraGTx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; Microrite, Inc.; Novo Nordisk; Oak Zone Biotech; Pharmaceutical and Healthcare Sciences Society; Roche Diagnostics Deutschland GmbH; Royal Free Hospital; RSSL; Sanofi; Sanofi Pasteur; Steris Corporation; Synthon Chile; TEVA Runcorn; Teva UK Ltd; The LFB Group; University of Southampton; University of Veterinary Medicine Vienna; zac vventures inc;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Olivier Chancel

Olivier Chancel, Sterility Assurance Expert, Boehringer Ingelheim
View Bio

9:10 Regulatory expectations and supportive guidance on Bio-contamination control and monitoring in Aseptic manufacturing of sterile products

James Drinkwater

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

• Regulatory requirements e.g. Annex 1, 2, Regulatory expectations e.g. Q&A, Blogs, supportive GMP Guidance e.g. PHSS, BioPhorum (BPOG) – how they relate and current harmonization initiatives.
• Preparation of a Contamination Control Strategy (CCS) – an Annex 1 requirement and Considerations in preparation of an Aseptic-Containment Strategy (ACS) if toxic or biologically active products are aseptically processed and/or cross contamination control is required.
• Risk based rationale and supporting risk assessments to setting environmental monitoring locations and sampling frequencies – PHSS and BPOG collaboration initiative.
 

9:50 Annex 1 Revision

• History of Annex 1
• Current Annex 1 key elements
• Early indicators of the changes expected in Annex 1
• Industry comments regarding the draft published in 2017
• Where now for Annex 1?
 

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma
View Bio

10:30 The Role of the Official Medicines Control Laboratories as the GMP back-up

Luis Meirinhos-Soares

Luis Meirinhos-Soares, Inspector, Infarmed - Instituto Naciuonal Da Farmacia E Do Medicamento
View Bio

• What is and What is not an Official Medicines Control Laboratory (OMCL)
• The role of OMCLs as the analytical hands-on support to GMP Inspections
• Pre-market and Post-market activities of OMCLs
• Examples of Good, Not-So-Good and Bad Practices as seen from the authorities perspective
 

11:10 Morning Coffee

11:40 Panel Discussion: The Impact of the Annex 1 Revision on Pharmaceutical Microbiology

• Which RMM technologies are being used without regulatory conflict on microbiological sampling results - Is industry ready for integration of digital platforms?
• The removal of contamination risk from operators through use of gloveless cells and robotics in filling platforms
• What does the unity of environmental classification, qualification and process monitoring mean to EM programs and data management of total particulate and microbiological samples?
• How do we manage risks associated with aseptic manufacturing of toxic and biologically hazardous products such as EM sample contamination, product cross contamination and personnel exposure?
• Assessing the disinfection rotation section on the use of multiple disinfectants to prevent the development of resistant strains – is there enough evidence?
• Revisiting the potential latent risk of VBNC and stressed microbial contamination in sterile product manufacturing
 

Olivier Chancel

Olivier Chancel, Sterility Assurance Expert, Boehringer Ingelheim
View Bio

James Drinkwater

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

Luis Meirinhos-Soares

Luis Meirinhos-Soares, Inspector, Infarmed - Instituto Naciuonal Da Farmacia E Do Medicamento
View Bio

Tim Eaton

Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
View Bio

Jim Polarine

Jim Polarine, Technical Service Manager, Steris Corp
View Bio

12:40 New At-line Automated Mycoplasma Testing: A Performance Evaluation of BioFire Mycoplasma

Sylvanie Cassard Guilloux

Sylvanie Cassard Guilloux, Global solution Manager, BioMérieux
View Bio

• Current methods description
• New technology: how it works? What are the benefits?
• Internal validation data according to Pharmacopeia guidelines
 

13:20 Networking Lunch

14:20 Current status of the MAT and rFc

Ingo Spreitzer

Ingo Spreitzer, Deputy head Section Microbial safety, Paul Ehrlich Institut
View Bio

• Foreseen modification of MAT 2.6.30.
• Feedback on draft rFc 2.6.32.
• European and global situation of MAT and rFc
 

15:00 Afternoon Tea

15:00 Automation for incubation and colony counting of Environmental Monitoring samples: process optimization and data integrity

Sonia  Allibardi

Sonia Allibardi, Market Access Manager, Copan Group
View Bio

Gabriele Savoldi

Gabriele Savoldi, Business Development Manager, Copan Group

16:10 Effective Risk Management of Microbial Contamination

Tim Eaton

Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
View Bio

• Risk assessment methods for microbial contamination
• Quantification of microbial contamination using environmental monitoring data
• Meaningful cleanroom environmental monitoring and Annex 1 considerations
• Effective risk based monitoring locations utilising appropriate risk factors
 

16:50 Microbial Control Considerations for Tablet Manufacture

Sophie Drinkwater

Sophie Drinkwater, QC Technical Officer, AstraZeneca
View Bio

• Overview of microbial control strategy of the manufacture of oral solid dosage forms
• Summary of three laboratory based challenge studies
 o Growth potential of microorganisms in coating suspensions
 o Behavior of microorganisms in tablet coating processes
 o Survival of microbes in wet granulation processes
• Application of Water Activity for risk-based testing plans
 

18:00 Chair’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

James Drinkwater

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

9:10 Container Closure Integrity and Controls Strategies Ensuring Product Sterility

Michael Song

Michael Song, Sr. Manager, AstraZeneca
View Bio

• Explore and learn when the utilize the different container closure integrity (deterministic and probabilistic) test methods mentioned in FDA guidance and USP <1207>
• New technologies with increased sensitivity…what is a good detection limit to target and when to draw the line
• How and when to utilize microbial challenge to help set manufacturing parameters
• Holistic approach in defining your container closure integrity controls strategy and aseptic assurance
 

9:50 Common Myths and Urban Legends in the Pharmaceutical Industry Related to Contamination Control

Jim Polarine

Jim Polarine, Technical Service Manager, Steris Corp
View Bio

• Disinfectant Quantity – The misconception that more disinfecting agent is always better for sanitization of surfaces.
• Microbiological Resistance – The misconception that micro-organisms will develop resistance over time to the use of disinfectants.
• Disinfection Rotation – The misconception that disinfection rotation is required to prevent microbiological resistance (i.e., Myth #1).
• Effectiveness of Isopropyl Alcohol¬ – The misconception that 70% Isopropyl Alcohol (IPA) is effective for control of fungal and bacterial spores.
 

10:30 Morning Coffee

11:00 Online Microbial Monitoring for Process Control of Pharmaceutical Waters

James Cannon

James Cannon, Head of OEM and Markets, Mettler-Toledo Thornton
View Bio

• Current state of real time microbial detection technology
• Case studies for the implementation of online microbial monitoring at pharmaceutical facilities
• Guidance for evaluation and establishment of new microbial limits
• The Pharmacopeia and Regulatory positions on validation of alternative microbial methods

 

11:40 Commissioning of a brand-new cleanroom facility from the environmental monitoring perspective

Maria Jose Zafra-Domene

Maria Jose Zafra-Domene, QC Microbiologist, MeiraGTx
View Bio

• The challenges of commissioning a brand-new facility
• Risk assessment of the cleanroom and the processes
• Establishing a routine Environmental Monitoring programme
 

12:20 Bacterial Endotoxins Test – Why are my CVs so high?

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

• What is correlation of variation and how to apply it in BET
• What causes high CVs in BET
• How to identify the root of high CVs
• How to mitigate high CVs 

 

13:00 Networking Lunch

14:00 Aseptic Audit Observations

Di Morris

Di Morris, Audit Manager CAGá, Gsk
View Bio

• What auditor/inspector expectations are
• What audit finding classifications can be used
• Examples of audit observations
• Keeping up to date
 

14:40 Microbial Robustness in Product Design

Pratixa Patel

Pratixa Patel, Microbiological Sciences Director, Glaxo Smith Kline
View Bio

• Impact of product design on manufacturing
• Going beyond Pharmacopeia Requirements
• Assessing the effectiveness of Microbial controls
 

15:20 Afternoon Tea

15:50 Importance of Microbiological Standards for Personalized Medicines and Compounding

Jason  McGuire

Jason McGuire, Vice President, Global Quality, Steriile Services to end
View Bio

• Review of current trends and practices in EU and US
• Implementation of technological advancements and other best practices
• Review of new guidances, guidelines, and regulatory enforcement activities
• A look into the future of global personalized medicine
 

16:30 Microbial Risk Assessment for Non-Sterile Oral Dosage Forms

David Elder

David Elder, Constultant, David P Elder Consultancy
View Bio

• Problem statement
• Risk Assessments
• Control strategy
• Objectionable organisms
• Conclusions
 

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

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FEATURED SPEAKERS

David Elder

David Elder

Constultant, David P Elder Consultancy
Di Morris

Di Morris

Audit Manager CAGá, Gsk
Ian Symonds

Ian Symonds

Director, Pharmaceutical Consultant, SDA Pharma
Ingo Spreitzer

Ingo Spreitzer

Deputy head Section Microbial safety, Paul Ehrlich Institut
James Cannon

James Cannon

Head of OEM and Markets, Mettler-Toledo Thornton
James Drinkwater

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS
Jason  McGuire

Jason McGuire

Vice President, Global Quality, Steriile Services to end
Jim Polarine

Jim Polarine

Technical Service Manager, Steris Corp
Luis Meirinhos-Soares

Luis Meirinhos-Soares

Inspector, Infarmed - Instituto Naciuonal Da Farmacia E Do Medicamento
Maria Jose Zafra-Domene

Maria Jose Zafra-Domene

QC Microbiologist, MeiraGTx
Michael Song

Michael Song

Sr. Manager, AstraZeneca
Olivier Chancel

Olivier Chancel

Sterility Assurance Expert, Boehringer Ingelheim
Pratixa Patel

Pratixa Patel

Microbiological Sciences Director, Glaxo Smith Kline
Sonia  Allibardi

Sonia Allibardi

Market Access Manager, Copan Group
Sophie Drinkwater

Sophie Drinkwater

QC Technical Officer, AstraZeneca
Sylvanie Cassard Guilloux

Sylvanie Cassard Guilloux

Global solution Manager, BioMérieux
Tim Eaton

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca
Veronika Wills

Veronika Wills

Manager, Technical Services, Associates of Cape Cod

David Elder

Constultant, David P Elder Consultancy
David Elder

Dr. Elder has 42 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in formulation, microbiology and analytical method development.
Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is the chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 18 book chapters, 147 papers in international journals and has given 19 webinars and over 167 presentations at national/international symposia. He has 9 patents to his name.
He has co-edited a book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines (with Andy Teasdale and Ray Nims).
 

Di Morris

Audit Manager CAGá, Gsk
Di Morris

Di Morris - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; Pharmaceutical industry for over 30 years/ a number of years as a Medicines Inspector for the MHRA. Di/worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs/worked with a wide range of dosage forms including sterile products, biological, and non-sterile products.

Gabriele Savoldi

Business Development Manager, Copan Group
Gabriele Savoldi

Ian Symonds

Director, Pharmaceutical Consultant, SDA Pharma
Ian Symonds

Recently established SDA Pharma Limited with co-managing Director Mike Davies. With almost 80 years’ experience in the industry SDA can provide a wide range of services form facility design and Qualification support to bespoke training and regulatory compliance advice.

My role in GSKs Global Quality was responsible for setting and monitoring Quality standards for the Global Manufacture and Supply division for pharmaceutical sterile manufacturing operations worldwide. Following the merger of GlaxoWellcome and SmithKlineBeecham in 2000 I established a team of subject matter experts to establish a common set of compliance standards for the new GSKs Quality Management System. I continued to lead that team right up to my retirement in 2018.

 

Ingo Spreitzer

Deputy head Section Microbial safety, Paul Ehrlich Institut
Ingo Spreitzer

My former research topics (Lectins) and immune-activating components of bacteria introduced me to preparation /purification and bioassays, which until today influences my work on immune-activating / pyrogenic substances. I started at the PEI 2001 with the development and validation of the Monocyte activation test (MAT).
My current duties as deputy at the PEI are drug QC by LAL (all methods) and Pyrogen testing (former rabbit pyrogen test, now replaced by MAT) and scientifically the exploration of the MAT. Our actual interests are drugs with intrinsic pyrogenicity, Outer membrane vesicles, synergistic effects and low Endotoxin recovery (LER).

 

James Cannon

Head of OEM and Markets, Mettler-Toledo Thornton
James Cannon

James B. Cannon is Head of OEM and Markets at Mettler-Toledo Thornton. He has a BSc in Biology, degrees in Microbiology and Biophysics and an MBA in Marketing and International Management.

Mr. Cannon has over 35 years of experience in the management, design and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialisation of electrodeionisation modules.

Mr. Cannon is currently involved in the standards and regulatory organisations for the Semiconductor, Photovoltaic and Pharmaceutical markets, and the commercialisation of alternative microbial technology.
 

James Drinkwater

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

James Drinkwater is Head of Aseptic processing technologies & GMP compliance for F Ziel Germany, supporting international projects from a base in the UK. As a subject matter expert in Barrier separation technology; Isolator / RABS and hydrogen peroxide vapour bio-decontamination, James is involved in applications of sterile pharmaceutical product Filling, Aseptic processing of APIs/ ATMPs and Sterility testing.
In addition to the role at F Ziel James has a voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society and leads the PHSS Aseptic processing & Bio-contamination special interest group.
 

Jason McGuire

Vice President, Global Quality, Steriile Services to end
Jason  McGuire

Jason has spent nearly 20 years in the health care industry serving in many roles with a particular focus on Quality control operations, Quality assurance and regulatory support. He’s a microbiologist by education and expertise, spending 2 years on the bench developing anaerobic microbial catalysts for fuel ethanol production. For the last 15 years, he has worked with non-sterile and sterile compounding facilities, national health systems, medical device, biotechnology and pharmaceutical companies helping them troubleshoot and bringing resolution to complex challenges.

Jim Polarine

Technical Service Manager, Steris Corp
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen 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 and microbial control in cleanrooms. 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 as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley 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.

Luis Meirinhos-Soares

Inspector, Infarmed - Instituto Naciuonal Da Farmacia E Do Medicamento
Luis Meirinhos-Soares

Head of the Microbiology Lab at INFARMED, the Portuguese Medicines Agency (PORTUGAL) for 16 years;
B.Sc. (Hons.) in, Biochemistry, and M.Sc. Biotechnology;
Expert of the European Pharmacopeia Working Groups (Microbiology, Blood Products, Biotechnology), Member of the Portuguese Pharmacopeia Commission, Auditor of the European OMCL Network (Microbiology and Biotechnology). Consultant for WHO Prequalification Program on Medicines, UNDP and UNICEF;
Invited Lecturer at the M.Sc. Quality Control (Univ. Porto), and at the B.Sc. in Biochemical Engineering (Univ. Lisbon)
Since January 2019 he joined the Pharmaceutical Inspectorate
 

Maria Jose Zafra-Domene

QC Microbiologist, MeiraGTx
Maria Jose Zafra-Domene

Originally from Spain, Maria relocated to the UK after completing her MSc in Biotechnology at the University of Granada. Maria began working as a QC Microbiology Technician in environmental monitoring at Nice Pak International in Flint (Wales), a wet wipes non-cleanroom manufacturing site. From here, Maria established her cleanroom environmental monitoring knowledge at Fresenius Kabi in Runcorn (England). After 6 years, she took on the position of QC Microbiologist in MeiraGTx, a gene therapy start-up based in London. Drawing from her experience, Maria has developed the environmental monitoring programme of a brand-new cleanroom facility within MeiraGTx. Now, she leads a team of QC Microbiology Technicians.

Michael Song

Sr. Manager, AstraZeneca
Michael Song

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Olivier Chancel

Sterility Assurance Expert, Boehringer Ingelheim
Olivier Chancel

Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility and Aseptic Practice Assurance Expert and Senior Quality Auditor. Used to work in or with the pharmaceutical industry for 20 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.
Published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices, has cowritten several books and also presented/moderated at various industry forums in Europe, Asia and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG...)
 

Pratixa Patel

Microbiological Sciences Director, Glaxo Smith Kline
Pratixa Patel

I am working as a Microbiology & Stability Science Senior Director at GlaxoSmithKline Consumer Health, with 15 years of experience working in various roles in Microbiology, Analytical and Quality Assurance.
 
I have previously worked at P&G and Dr Reddys Laboratories. At Dr Reddys I held a position of Head of Microbiology for sterile, non-sterile and API manufacturing operations. I was responsible for setting the strategy to develop Microbiology systems and controls throughout the global supply chain and provided leadership to the micro function. Prior to that, I have worked at Procter & Gamble for 12 years including EMEA Regional Microbiology Head and Global head for Quality Analytical. I have held various assignments across R&D, Manufacturing and Commercial functions. My expertise is deeply rooted in Microbiology QbD, manufacturing controls, risk mitigation plans as well as organisational development of technical functions.
 
I hold a BSc degree in Microbiology and Virology (University of Warwick, UK) and a PhD in Biofilm research from the University of Birmingham, UK.
 

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
Renate Rosengarten

Sonia Allibardi

Market Access Manager, Copan Group
Sonia  Allibardi

Molecular biologist with a specialization degree in Biochemistry Science. Currently working in the Scientific Team of COPAN as Market Access Manager for the implementation of innovative Medical Devices in pre-analytics focusing on Italy, Eastern Europe and Asia Pacific Market. Her professional life started in a research Cardiovascular Physiology laboratory at San Raffaele Scientific Institute, Milan Italy, where She worked for more than 10 years and published scientific papers on International Journals. The objective of her research was the evaluation of myocardial metabolism in hypoxic and ischemic heart. In 2011, thanks to the “Mad Cow Disease”, She started a new job in Biorad Company. She spent three years as scientific product specialist in the life science division for Italy and Southern Europe (Spain, Greece, Portugal). She moved to Cepheid Europe for five years where her main topics were: Women’s Health, Hospital Acquired Infection and Tuberculosis.

Sophie Drinkwater

QC Technical Officer, AstraZeneca
Sophie Drinkwater

I’m a microbiologist at AstraZeneca, where I have worked for almost 5 years; I’ve spent most of that time in the QC Microbiology labs, but recently I had the opportunity to spend 18 months in Pharmaceutical Technology & Development; this has led to collaborative studies in supporting the microbial control strategy of our oral solid dosage forms and sterile products. I’ve recently transferred to the role of a Technical Officer, where I will be driving microbiology method development and optimisation, including the implementation of modern microbiology techniques.

Sylvanie Cassard Guilloux

Global solution Manager, BioMérieux
Sylvanie Cassard Guilloux

Sylvanie has a strong scientific background (PhD at Paris VII University; post-doctoral experience at Rockefeller University) in cellular and molecular biology. On her return to France, Sylvanie joined industry, and had 13 years of experience as technical leader or in R&D in several laboratories, developing and using molecular methods for industry quality controls, while she also participated to standardization of these methods as a group leader at the french normalization body (AFNOR). In 2012, after a Master of Business at Audencia business school, she joined the global marketing department of bioMérieux, where she is defining and guiding the development of new solutions for pharmaceutical microbiological controls.

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca
Tim Eaton

Tim Eaton B.Sc. (chemistry) has over 25 years’ experience of steriles manufacture with Zeneca Pharmaceuticals and AstraZeneca. During this time he has had extensive roles in technical support, production management and specialist activities for aseptically prepared products. He has had responsibilities for the design, construction, start up and validation of multimillion pound aseptic manufacturing facilities and has managed the introduction, technical transfer and scale up activities for a number of sterile products. He has published a number of papers relating to cleanroom activities and has also presented at various industry forums in Europe, Asia and the US.
In his current role of Sterile Manufacturing Specialist he has responsibilities for the derivation, optimisation and implementation of best practices for aseptically prepared products. He sits on LBI/30, the British Committee for Cleanroom Technology.
 

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

Sponsors

Exhibitors

Official Media Partner

Supporters

Workshops

Pharmaceutical Microbiology Workshop Day
Workshop

Pharmaceutical Microbiology Workshop Day

Copthorne Tara Hotel
22nd January 2020
London, United Kingdom

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

Speaker Interview with James Cannon

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Speaker interview with Michael Christian Davies

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Speaker interview with Dr. Ingo Spreitzer

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Pharmaceutical Microbiology UK Infographic

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Chair Invite Letter

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Pharma Microbiology Workshop Day 22 Jan 2020

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Pharma Microbiology 2020 Speakers

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Pharmaceutical Microbiology UK Brochure 2020

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Pharma Microbiology 2020 2-day agenda

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Past Attendees 2017-2019

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PAST PRESENTATION 2019 - Di Morris - GSK

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PAST PRESENTATION 2019 - Laurent Leblanc - Biomerieux

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PAST PRESENTATION 2019 - Thierry Bonnevay - Sanofi Pasteur

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PAST PRESENTATION 2019 - Olivier Chancel - Boehringer Ingelheim

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PAST PRESENTATION 2019 - Dr. Sonia Allibardi - COPAN Italia

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Sponsors


Associates of Cape Cod

Sponsors
http://www.acciusa.com/acc/index.html

Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1?3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


bioMérieux

Sponsors
http://www.thepeoplebehindthescience.com

bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.


COPAN

Sponsors
http://www.copangroup.com

With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com


METTLER TOLEDO

Sponsors
http://www.mt.com

METTLER TOLEDO Thornton has a long history of delivering real time, continuous measurement products specifically designed for regulated pharmaceutical water systems such as Conductivity, TOC, and Ozone. The 7000RMS Real time Microbial System instantly detects and counts microbial (bioburden) presence enabling increased sensitivity, better process control, improved product quality, and reduced risk.

Exhibitors


Microbiologics

Exhibitors
http://www.microbiologics.com

At Microbiologics, our mission is: "To provide the highest quality biomaterials for a safer, healthier world." We are the leading provider of ready-to-use QC microorganisms for quality control testing in the clinical, pharmaceutical, food, water and educational industries. With over 900 strains available in a variety of user-friendly formats, we offer the largest and most diverse line of QC microorganisms including qualitative, quantitative, Certified Reference Material and Parasite Suspensions. Our products are manufactured in accordance with the industry’s highest standards. We have achieved ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. In addition, we are an FDA registered establishment and offer many CE Marked products.


Microgenetics

Exhibitors
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



RSSL

Exhibitors
http://www.rssl.com

RSSL provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located in the UK and with our team of more than 300 dedicated employees, we ensure that every project is performed with our commitment to outstanding quality, scientific excellence and customer satisfaction. We offer a large portfolio of, chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle.


Veltek Associates Inc

Exhibitors
www.sterile.com

Veltek Associates, Inc. (VAI) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with our environmental air sampling equipment to determine levels of contamination present in the air, Veltek is committed to providing our customers with the highest quality products.

Media Partners


Rapid Microbiology.com

Official Media Partner
https://www.rapidmicrobiology.com

rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.

Media Partners


Genetic Engineering News

Supporters
http://www.genengnews.com

Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


Farmavita

Supporters
https://farmavitar.com

FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


IPI

Supporters
http://www.ipimediaworld.com

IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


Pharmalicensing

Supporters
http://www.pharmalicensing.com

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


Drug Discovery Today

Supporters
http://www.drugdiscoverytoday.com/

Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


MedTube

Supporters
https://medtube.net/



Swiss Biotech Association

Supporters
http://www.swissbiotech.org/

The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


SciDoc Publishers

Supporters
http://www.scidoc.org

SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


pharmaphorum

Supporters
http://www.pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


Pharmavision

Supporters
http://www.pharmavision.co.uk

PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


Contract Biotechnology

Supporters
http://www.contract-biotechnology.com

Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


Drug Target Review

Supporters
http://www.drugtargetreview.com

Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


Drug Development Technology

Supporters
http://www.drugdevelopment-technology.com

Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


Pharmaceutical Technology

Supporters
http://www.pharmaceutical-technology.com

Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


American Pharmaceutical Review

Supporters
http://www.americanpharmaceuticalreview.com

Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


Biocompare

Supporters
http://www.biocompare.com

Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


Gate2Biotech

Supporters
http://www.gate2biotech.com

Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


Mednous

Supporters
http://www.MedNous.com

MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


World Pharma News

Supporters
http://www.worldpharmanews.com/


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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.

 

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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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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
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