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SMi’s 10th Annual Conference
Pharmaceutical Microbiology UK
January 17 - 18, 2022 | Virtual Conference, Online Access Only
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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 establishing holistic Contamination Control Strategies and Real-Time Viable Air Particle Counting with leaders in the pharmaceutical industry
  • GAIN insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation
  • EXPLORE the best practice in data integrity and the automation of environmental monitoring in the Microbiology Quality Control Lab
  • JOIN the important panel discussion on diversity and inclusion in the workplace with an experienced line-up of life science speakers
  • 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
View Bio

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

Peter Annel

Peter Annel, Principal Scientist, Novo Nordisk A/S
View Bio

• 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
View Bio

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

10:30 Morning Coffee

11:00 The changing landscape of microbiology tech in pharmaceuticals

Edward Webber

Edward Webber, Product Specialist, Microgenetics Ltd
View Bio

• Learn how new technologies from rapid sterility testing to data storage systems can improve your processes
• Find out why these technologies are increasingly important for our industry which, so far, has been slow to change
• Hear about examples of such technology, and how they’re changing the pharmaceutical landscape
• Find out why validation can be a challenge, and how to overcome it in your facility
• Consider some future uses of technologies within pharmaceutical manufacturing microbiology
 

11:40 Sanofi Pasteur Mycoplasma techno roadmap and implementation of mycoplasma alternative method to release human vaccines

Thierry Bonnevay

Thierry Bonnevay, Microbiological Analytical Expert, Sanofi Pasteur
View Bio

• 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
 

12:20 Networking Lunch

13:20 Contamination Control Strategy - a wholistic way to maintain sterility assurance

Martin Mullner

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

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

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
View Bio

• 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 Afternoon Tea

15:10 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
View Bio

Suzanne Nutter

Suzanne Nutter, QA Group Manager, AstraZeneca
View Bio

Di Morris

Di Morris, Clinical Auditor, AstraZeneca
View Bio

15:50 Applying QRM as part of a Contamination Control Strategy and EU GMP Annex 1

Conor Murray

Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
View Bio

• QRM and Contamination Control Strategy expectations in EU GMP Annex 1
• GMP Compliance and Principles of establishing control and then demonstrating control
• QRM and fundamental elements of a Contamination Control Strategy
• Role of ISO/EN Standards and Classification VS Monitoring
• Engineering Controls and the importance of Commissioning and Qualification as part of Annex 15 (Q&V)
• Application of ISO 14644-2 and the new EN 17141 on microbiological control to integrated Non-Viable and Viable EM
• Intelligent CCS decision making based on integrated EM data to ongoing GMP compliance
 

16:30 Chair’s Closing Remarks and Close of Day One

Di Morris

Di Morris, Clinical Auditor, AstraZeneca
View Bio

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Di Morris

Di Morris, Clinical Auditor, AstraZeneca
View Bio

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

Di Morris

Di Morris, Clinical Auditor, AstraZeneca
View Bio

• 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 A Look into Rapid Microbial Contamination Detection in Cell-containing Samples

Johannes Oberdoerfer

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

• Current challenges of conventional methodologies
• Beta Testing of Celsis Adapt™ system at Boehringer Ingelheim
• Technology features and perspectives for the pharmaceutical Industry
 

10:30 Morning Coffee

11:00 Developing Wipe Efficacy Validation for the Pharmaceutical Industry

David Collins

David Collins, Global Technical Consultant, Ecolab Life Sciences
View Bio

• 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, Associate Director - Head of Microbiology, Pharmaceutical Development, AstraZeneca
View Bio

Suzanne Nutter

Suzanne Nutter, QA Group Manager, AstraZeneca
View Bio

12:20 Networking Lunch

13:20 Current state of Pyrogen- and Endotoxin Testing

Ingo Spreitzer

Ingo Spreitzer, Deputy Head, Section 1/3 Microbiological Safety, Paul Ehrlich Institut
View Bio

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

14:00 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
View Bio

• 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
 

14:40 Afternoon Tea

15:10 Phasing of Environmental Classification and Qualification (Annex 1 requirement) at rest and in operation and connection to APS: Media fill Qualification

James L. Drinkwater

James L. Drinkwater, Head of GMP compliance and Aseptic Processing support, F Ziel GmbH and PHSS
View Bio

• Application of Environmental Classification (0.5micron particles) at rest and in-operation following principles of ISO14644-1 applied to GMP following QRM principles
• Application of Environmental Qualification, in-operation including EM (particles 0.5 & 5.0 micron and Micro) plus PM: Process monitoring (physical parameters related to contamination control and process requirements)
• Aseptic process simulations (APS): Media fill Qualifications – strategies and key points to consider
• Routine EM + PM for production operations with trending and periodic review
 

15:50 Chair’s Closing Remarks and Close of Day Two

Di Morris

Di Morris, Clinical Auditor, AstraZeneca
View Bio

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FEATURED SPEAKERS

Benoit Ramond

Benoit Ramond

Head of Microbiology & Sterile Technology, Sanofi
Conor Murray

Conor Murray

Principal Consultant, 3dimension Cleanrooms Limited
David Collins

David Collins

Global Technical Consultant, Ecolab Life Sciences
Di Morris

Di Morris

Clinical Auditor, AstraZeneca
Edward Webber

Edward Webber

Product Specialist, Microgenetics Ltd
Ingo Spreitzer

Ingo Spreitzer

Deputy Head, Section 1/3 Microbiological Safety, Paul Ehrlich Institut
James L. Drinkwater

James L. Drinkwater

Head of GMP compliance and Aseptic Processing support, F Ziel GmbH and PHSS
Jim Polarine

Jim Polarine

Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation
Johannes Oberdoerfer

Johannes Oberdoerfer

Scientist of Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
Karen Capper

Karen Capper

Associate Director - Head of Microbiology, Pharmaceutical Development, AstraZeneca
Martin Mullner

Martin Mullner

Senior Quality Assurance Manager, Boehringer Ingelheim Pharma GmbH & Co. KG
Peter Annel

Peter Annel

Principal Scientist, Novo Nordisk A/S
Ren-Yo Forng

Ren-Yo Forng

Scientific Director, Amgen
Shabnam Solati

Shabnam Solati

CEO, CTL-MAT, LLC
Stephen Smith

Stephen Smith

Global Pharma Consultant, Novatek Europe
Suzanne Nutter

Suzanne Nutter

QA Group Manager, AstraZeneca
Sven Deutschmann

Sven Deutschmann

Head of Global ASAT, Global QC, Roche Diagnostics GmbH
Thierry Bonnevay

Thierry Bonnevay

Microbiological Analytical Expert, Sanofi Pasteur

Benoit Ramond

Head of Microbiology & Sterile Technology, Sanofi
Benoit Ramond

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

Conor Murray

Principal Consultant, 3dimension Cleanrooms Limited
Conor Murray

Conor Murray has over 30 years’ experience in design and construction of cleanrooms and biosafety labs, and since 2007 independently in an oversight and auditing role. Conor represents the National Standards Authority of Ireland (NSAI), as Head of Delegation and a SME at ISO/TC209 and the European mirror CEN/TC243 on cleanroom standardisation. Conor is a past Convenor of CEN/TC243 WG-05 on biocontamination control and the recently published EN 17141 standard. Conor is the Chair of the Healthcare Services Committee advising the Irish Health Service Executive on standards compliance. Conor is Chair of the Irish Cleanrooms Society (ICS) and a past Chair of the International Confederation of Contamination Control Societies, (ICCCS). Conor lectures internationally and gives cleanroom training and education courses on behalf of the ICS.

David Collins

Global Technical Consultant, Ecolab Life Sciences
David Collins

David Collins is a graduate biologist holding over 8 years experience within pharmaceutical and cosmetic microbiology. Attending the University of Portsmouth, David obtained his First-Class honours in Biology later completing a placement within the stem cell research laboratories at the University of Palermo, Sicily. David began his career in microbiology within the cosmetics industry. He progressed as QA Microbiologist from a third-party cosmetics manufacturer joining The Estée Lauder group for the research and development of personal care products. Alongside the management of preservative efficacy testing and routine microbiological methods, he was responsible for reviewing and assessing deviations and conducting site audits globally to assess quality and validity of product manufacture and batch release testing. David has also held the position as microbiologist at GlaxoSmithKline, responsible for environmental quality assurance within the pharmaceutical manufacturing site. He performed microbiological monitoring for oral, sterile, primary and stability products adhering to strict GMP requirements and regularly analysing microbiological trends within the cleanroom and controlled environments. Prior to joining Ecolab, David was Quality Manager for a contract microbiology laboratory managing and maintaining the UKAS accredited Quality Management System ensuring compliance to ISO 17025 and to the GMP standards required by both MHRA and FDA.

Di Morris

Clinical Auditor, AstraZeneca
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.
 

Edward Webber

Product Specialist, Microgenetics Ltd
Edward Webber

Edward Webber is a Quality professional turned Product Specialist for Microgenetics. Before joining Microgenetics in 2021, Ed has worked in several microbiological facilities, most recently managing the QC Microbiology laboratory at Porton Biopharma. As such has a deep understanding around the importance of technologies used in the pharmaceutical manufacturing industry. At Microgenetics, he is the voice of Quality professionals, writing technical articles and ensuring products will help to solve some of the biggest challenges in environmental monitoring and QC microbiology.

Ingo Spreitzer

Deputy Head, Section 1/3 Microbiological 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 L. Drinkwater

Head of GMP compliance and Aseptic Processing support, F Ziel GmbH and PHSS
James L. Drinkwater

Together with the role at F Ziel James is the elected Head of the Not-for-Profit PHSS: Pharmaceutical & Healthcare Sciences Society Aseptic processing and Containment special interest groups. James is a Pharmaceutical process engineer with additional education in Pharmaceutical microbiology. Working experience includes 10 years in radio pharmaceutical manufacturing and over 20 years working in sterile product manufacturing support where increasingly aseptic processing applies. James is a Subject matter expert in Barrier Technology (Isolators and RABS) and Bio-decontamination with Hydrogen peroxide vapour (H202-VHP). James is also a Member of ISPE and Pharmaceutical Quality Group UK (PQG).

Jim Polarine

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

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 with FDA, MHRA, HPRA, ANVISA, and ANMAT 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

Scientist of 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.
 

Karen Capper

Associate Director - Head of Microbiology, Pharmaceutical Development, AstraZeneca
Karen Capper

Karen is a pharmaceutical microbiologist with over 30 years’ experience in microbiology positions within the pharmaceutical industry. She has extensive knowledge in managing and operating QC microbiological and analytical laboratories as well as manufacturing experience in aseptic production. She has specialist knowledge in the microbiological assurance of aseptic processes, environmental control of non-sterile pharmaceuticals and API facilities. She currently leads the Global Microbiology Team in Product Development and is responsible for the microbiological assurance and testing of the products in development by AstraZeneca. Karen is also a course tutor for the PMAT Course at Manchester University where she tutors the GMP in Microbiology Laboratories and Antimicrobials Units.

Martin Mullner

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

06/2018 – dato Senior Quality Manager (Boehringer Ingelheim Corporate Center GmBH)
• Global Quality Assurance for Aseptic Manufacturing / Environmental Monitoring & Microbial Testing. Steering of the global expert network, facilitating best practice sharing and production site support. Creating and maintaining the respective corporate document landscape. Member of global project teams for software solutions as process owner.
12/2012 – 06/2018 Head of Quality Control Microbiology (Boehringer Ingelheim GmbH&Co.KG)
• Local Management System Owner for Microbiology.
• Environmental/Clean Utilities Monitoring Program for an aseptic filling line at the Ingelheim site.
• Assessment and readout of aseptic processes (Media-Fill).
• Microbial purity and sterility testing of API, excipient und drug product.
• Comprehensive experience in inspections (e.g. FDA, ANVISA, KFDA, LSJV, etc.).
• Project experience in the microbiological laboratory Redesign project, the RAMP-UP project of an aseptic filling line and as a Team Member of the ClassD Project at the Ingelheim site.
• Member of the Aseptic Working Group.
• Maintaining of an external network for the exchange of experience with active participation in benchmarking. This included organization of the annual meeting of the “VFA UA Mikrobiologie” 2017 and the annual meeting of the “CPM - Curriculum für Pharmazeutische Mikrobiologie” in 2013.
 

Peter Annel

Principal Scientist, Novo Nordisk A/S
Peter Annel

DVM in 1983. worked with microbiology since 1984. With Novo Nordisk since 1996, principal scientist since 2004. Worked in micro-QC, API production and product development, providing support and troubleshooting to micro-labs and API and FP production departments on microbial issues as well as training in general microbiology, aseptic behaviour etc.
Member of EDQM group 1, Microbiology, since 2011.
 

Ren-Yo Forng

Scientific Director, Amgen
Ren-Yo Forng

Ren-Yo Forng joined Amgen in 2015 as the Scientific Director of Microbiology in Process Development organization. His working experiences included research in microbiology and virology as well as manufacturing technical support and quality organizations in Bristol-Myers Squibb and AstraZeneca Biologics. Ren-Yo holds M.S. and Ph.D. degrees from the Laboratory of Microbial and Biochemical Sciences program from Georgia State University. He leads the effort in evaluation of innovative microbiological technologies, development and improvement of methods, and developing microbial control strategies in his role. Additionally, he supports subjects associated with manufacturing of drug substances and drug products where microbiology expertise or guidance is needed.

Shabnam Solati

CEO, CTL-MAT, LLC
Shabnam Solati

With 15 years experience in both academics and the field, Shabnam Solati is a key thought leader in the area of Monocyte Activation Testing (MAT). Having designed, produced and
brought to market the world’s leading commercialised MAT kit, Shabnam partners with the very largest pharmaceutical manufacturers in their transition away from in-vivo assays towards the MAT as their batch release pyrogen test.

Stephen Smith

Global Pharma Consultant, Novatek Europe
Stephen Smith

Stephen Smith is a global pharmaceutical consultant for Novatek Europe.

Stephen is responsible for Europe and South America offering Compliance Software within pharmaceuticals and Bio-Pharmaceutical marketplace – including Sales activities, services and support

Stephen also plays a key role in strategic continued development of consultant relationships, ensuring flexibility in response to an increasing demanding global marketplace.

Prior to joining Novatek Stephen held a longstanding role within IT infrastructure, Software and Robotics servicing Healthcare and pharmaceuticals within Europe, South America, Japan and China.

Stephen earned multiple degrees from various Universities in the United Kingdom.
 

Suzanne Nutter

QA Group Manager, AstraZeneca
Suzanne Nutter

Suzanne is an eligible Qualified Person under the permanent provisions of the European Pharmaceutical Directives and is a Pharmacist by profession with over 25 years of experience in the industry. She has performed a wide range of roles in Sterile Manufacturing, Technical and Change Management, Quality Control Microbiology, Quality Assurance, Community Pharmacy and most recently the design, qualification and validation of a large Sterile Advanced Aseptic Manufacturing Facility.
She is also an active member of the PHSS and sits on the EJPPS editorial board.
 

Sven Deutschmann

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

Sven Deutschmann studied biology at the University of Brunswick where he obtained his PhD in cell culture technology. His current position is Head of Global Analytical Science and Technology “Adventitious Agents Testing & Alternative Microbiological Methods” within Global QC.

Besides his internal responsibilities Sven is member of the German Pharmacopeia Commission, and the Microbiology Committee of the German Pharmacopeia Commission as well as Germany’s representative in the Working Parties “Bacterial Endotoxins”, “Mycoplasmas” (whose chairman he is) and Expert Group 1 “Biological Methods and Statistical Analysis” (whose chairman he is) of the European Pharmacopeia Commissions in Strasbourg, France. In 2009 he was appointed as commissioner of the Central Commission for Biological Safety, a brains trust of the Federal Office of Consumer Protection and Food Safety. In addition, Sven is chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology” Interest Group.
 

Thierry Bonnevay

Microbiological Analytical Expert, Sanofi Pasteur
Thierry Bonnevay

Thierry Bonnevay has more than 25 years of experience in the field of microbiological quality control, acquired within the Sanofi Pasteur company and has held various positions in this field both in industrial affairs and in R&D. His current position is Global Analytical Microbiology Expert. He is a member of the USP Expert Group on Modern Microbiological Methods (MMM) since 2015 and a member of the European Pharmacopoeia Expert Group EDQM within Group 1 Microbiology (since 2016), the Bacterial Endotoxins Working Group (WP BET) since 2017 and the Mycoplasma Working Group (WP MYC) since 2018. Finally, he is part of the board of the French association A3P since 2017.

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VENUE

Online Virtual Event

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Pharmaceutical Microbiology 2022 Preliminary Attendee List

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Sponsor Speaker Interview - David Collins, EcoLab Life Sciences

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Pharmaceutical Microbiology Conference 2022 Brochure

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SPEAKER INTERVIEW - Karen Capper, AstraZeneca

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Speaker Interview - Johannes Oberdöerfer, Boehringer Ingelheim

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Pharmaceutical Microbiology 2022 Speaker Biographies

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Workshop A & B Detailed Programme

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Pharmaceutical Microbiology 2022 Agenda at a Glance

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Pharmaceutical Microbiology 2022 Detailed Programme

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Past Attendees List

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Past Speaker Presentation - AstraZeneca

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Past Speaker Presentation - PHSS

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Past Speaker Presentation - C.T.L. MAT

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Past Speaker Presentation - Fresenius Kabi

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Past Speaker Presentation - Copan

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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


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American Pharmaceutical Review

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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

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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.


Rapid Microbiology.com

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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.

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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


Pharmavision

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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.


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.


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


Pharmacircle

Supporters
http://www.pharmacircle.com

PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


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.


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.


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.


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.


MedTube

Supporters
https://medtube.net/



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.


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!


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.

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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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