SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
Biopharma Production and Development China 2015 Rita Barry
As the BioPharma industry grows in China and the Asian region, we invite you to be a part of this tremendous growth & development opportunities!
IBC’s Biopharma Development & Production Week in China is THE meeting place for biopharma industry professionals and scientists to get the highest quality and practical information that will enable them to develop competitive advantages and advance their capabilities in developing and manufacturing cell lines, biosimilars, biobetters, vaccines or novel biologics.
Top Reasons Why You Should Participate:
- Establish Business Partnerships with Chinese/Asian drug developers and contract
manufacturers
- Learn technical & practical know how from experiences on the ground in Asia
- Showcase your cutting edge solutions in front of key China/Asian Biopharma
decision makers
http://www.biopharmaproduction.com
Holistic Approaches to Virus Risk MitigationMilliporeSigma
Presented at INTERPHEX on March 21-23, 2017.
Regulatory guidelines have shaped industry best practices around adventitious virus contamination risk mitigation in terms of patient safety. A recent survey indicated that the cost to remediate a virus contamination can run into millions of dollars, not including commercial impact. Today, the industry is taking a closer look at minimizing the business risk associated with viral contaminations and is taking a more holistic view of risk mitigation. This approach includes virus prevention and detection in addition to removal. From cell culture seed train to final fill vial, the discussion will describe the potential risks associated with different areas of biotech processes and what can be done to minimize adventitious virus risk in those areas. The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, testing and regulatory considerations.
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
Mitigating Supply Chain Risk using Big Data AnalyticsMilliporeSigma
Access the interactive recording: https://bit.ly/2M2fvWS
Abstract:
Growth and expansion in the biopharmaceutical industry have increased the vulnerability of the global supply chain to disruptions. At the same time, stronger regulatory oversight has been introduced to assure patient access to life-saving drugs. To stay ahead of these two factors, we are making “risk-smart” decisions to balance investments in capacity and supply programs.
The routine, reliable supply of products to biopharmaceutical manufacturers depends upon a disciplined approach to supply chain management and risk management. This webinar will talk about supply chain risk management, and more specifically how big data analytics can help strengthen supply chains.
In this webinar, you will learn more on:
- Our supply risk management program
- How we use big data analytics to determine risks
David Glass BIO World Congress Synthetic Biology Regulation july 2015David Glass
Presentation from July 2015 BIO World Congress on Industrial Biotechnology, assessing the adequacy of government regulatory frameworks to assess the risks of commercial uses of synthetic biology.
Sterilization Validation for Medical DevicesDocKetchum
Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.
Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.
These are some of the most common ways that sterilization validation is performed.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
Biopharma Production and Development China 2015 Rita Barry
As the BioPharma industry grows in China and the Asian region, we invite you to be a part of this tremendous growth & development opportunities!
IBC’s Biopharma Development & Production Week in China is THE meeting place for biopharma industry professionals and scientists to get the highest quality and practical information that will enable them to develop competitive advantages and advance their capabilities in developing and manufacturing cell lines, biosimilars, biobetters, vaccines or novel biologics.
Top Reasons Why You Should Participate:
- Establish Business Partnerships with Chinese/Asian drug developers and contract
manufacturers
- Learn technical & practical know how from experiences on the ground in Asia
- Showcase your cutting edge solutions in front of key China/Asian Biopharma
decision makers
http://www.biopharmaproduction.com
Holistic Approaches to Virus Risk MitigationMilliporeSigma
Presented at INTERPHEX on March 21-23, 2017.
Regulatory guidelines have shaped industry best practices around adventitious virus contamination risk mitigation in terms of patient safety. A recent survey indicated that the cost to remediate a virus contamination can run into millions of dollars, not including commercial impact. Today, the industry is taking a closer look at minimizing the business risk associated with viral contaminations and is taking a more holistic view of risk mitigation. This approach includes virus prevention and detection in addition to removal. From cell culture seed train to final fill vial, the discussion will describe the potential risks associated with different areas of biotech processes and what can be done to minimize adventitious virus risk in those areas. The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, testing and regulatory considerations.
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
Mitigating Supply Chain Risk using Big Data AnalyticsMilliporeSigma
Access the interactive recording: https://bit.ly/2M2fvWS
Abstract:
Growth and expansion in the biopharmaceutical industry have increased the vulnerability of the global supply chain to disruptions. At the same time, stronger regulatory oversight has been introduced to assure patient access to life-saving drugs. To stay ahead of these two factors, we are making “risk-smart” decisions to balance investments in capacity and supply programs.
The routine, reliable supply of products to biopharmaceutical manufacturers depends upon a disciplined approach to supply chain management and risk management. This webinar will talk about supply chain risk management, and more specifically how big data analytics can help strengthen supply chains.
In this webinar, you will learn more on:
- Our supply risk management program
- How we use big data analytics to determine risks
David Glass BIO World Congress Synthetic Biology Regulation july 2015David Glass
Presentation from July 2015 BIO World Congress on Industrial Biotechnology, assessing the adequacy of government regulatory frameworks to assess the risks of commercial uses of synthetic biology.
Sterilization Validation for Medical DevicesDocKetchum
Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.
Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.
These are some of the most common ways that sterilization validation is performed.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
India's first Int'l Conference on Best Practices in Pharma Microbiology Biocon
This is the first time that Pharmig, an international Pharmaceutical Microbiology think tank based out of the UK is organizing a conference on the "Best Practices in Pharma Microbiology" for the first time in India. You can register
by sending an email to maxine@pharmig.org.uk. For booking a seat for the conference, please visit: http://bit.ly/1J4gtLh
Aseptic Process Sampling to address Risk of Contamination & Containment in co...Merck Life Sciences
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
How does the ICH Q5A revision impact viral safety strategies for biologics?MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Endotoxin Control and Clearance in BiomanufacturingMilliporeSigma
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
1. WORKSHOP A
Spectrometric and Optical Technologies
for Microbial Contamination Control
Leader: Andrew Bartko, Research Leader, Battelle
8.30 am - 12.20pm
WORKSHOP B
Endotoxin Testing: Hot Topics and New
Methods in the European Pharmacopoeia
Leader: Karolina Heed, Director, Marketing and Sales, Hyglos GmbH
1.00 pm - 4.40pm
SMi Presents the 5th Annual Conference on...
20 - 21
JAN
2016Holiday Inn Kensington Forum, London, UK
Pharmaceutical
Microbiology
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS
Tuesday 19th January 2016, Holiday Inn Kensington Forum, London, UK
www.pharma-microbiology.com | #smimicrobiology
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Chairs for 2016:
• Oliver Chancel, Sterility and Aseptic Process Assurance
Expert, Merial Sas
• Francesco Boschi, Microbiological Services Manager,
GSK Manufacturing S.p.A
• Salomé Gião, Research Scientist, Dyson Technology Ltd
Key Speakers for 2016:
• Thierry Bonnevay, Microbiology Platform Head QC
Development, Sanofi Pasteur
• Adrianne Klijn, Group Leader Microbiological and
Molecular Analytics, Nestle Research Center
• Sabina Lancaster, Senior Manager, Sterility Assurance,
Global, QA, GSK
• James Drinkwater, Chairman, PHSS
• Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
Benefits of attending in 2016:
• Gain an in-depth insight into endotoxin testing, validation
and LER
• Understand the threats posed by VBNCs and how to detect
them
• Hear specialist advice on contamination control and risk
management to minimise costs and maximise efficiency
• Gain an international perspective with case studies from
across the UK, EU, and USA
@SMIPHARM
Pioneering new techniques for the prevention
detection and management of microorganisms
Sponsored by
Book by 30th September 2015 to save £400
Book by 30th October 2015 to save £200
Book by 30th November 2015 to save £100
“Real life experience” MedImmune
“Interesting with real case study”Merck Serono RBM
2. Pharmaceutical Microbiology
Day One | Wednesday 20th January 2016
8.30 Registration & Coffee
9.00 Chair's Opening Remarks
Oliver Chancel, Sterility and Aseptic Process Assurance
Expert, Merial Sas
New Mechanisms for Detection and Quality Control
9.10 Particle deposition monitoring the missing link in
contamination control
• Product contamination
• Air and surface cleanliness
• Particle deposition
• Real time particle deposition measurement
Koos Agricola, Contamination Control Specialist,
International Confederation of Contamination Control
Societies
9.50 Use of RMM in bacteriology lab: Application and
implementation
• Quantitative bioburden by Chemscan
• Rapid sterility testing by rapid milliflex
• Detection of mycoplasma by PCR+microarray
Thierry Bonnevay, Microbiology Platform Head QC
Development, Sanofi Pasteur
10.30 Morning Coffee
11.00 Advanced light microscopy to detect VBNC pathogens
and biofilms
• Advantages of EDIC microscopy
• Providing a rapid, real time analysis of biofilms on
opaque, curved, natural or man-made surfaces
• Utilising a toolbox of physiological detection techniques
to assess viability
• Visualising VBNC pathogens and biofilms in situ
Bill Keevil, Scientific Advisor to the House of Commons
Select Committee on Science & Technology, Head of the
Microbiology Group and Director of the Environmental
Healthcare Unit. University of Southampton, UK,
University of Southampton
11.40 DNA-sequencing based methods: How will they shape of
routine microbial testing in the future?
• Learn about new mechanisms of bacterial detection
using sequencing mechanisms
• Gain an insight into rapid microbiology sequencing
methods
Adrianne Klijn, Group Leader Microbiological and
Molecular Analytics, Nestle Research Center
12.20 Networking Lunch
Register online at: www.pharma-microbiology.com • Alternatively fa
Sponsored by
1.50 Operating a bioburden control facility within the vaccine
industry
• Bioburen control strategy following recent updates to
vaccine regulations
• Case study of how the bioburden control strategy can
be applied
• Calculating bioburden limits and understanding the risk
to a bioburden control process.
Sabina Lancaster, Senior Manager, Sterility Assurance
Global QA, GSK
Contamination and Endotoxins
2.30 Endotoxin testing of biologics – new insights
• Regulatory requirements, hold-time studies
• New endotoxin test procedures for in-process control
and product release
• Influence of major formulation components on
endotoxin detectability
• Theory of endotoxin masking
(Low Endotoxin Recovery, LER) and
recovering masked endotoxin - Case studies
Holger Grallert, Vice President, Hyglos GmbH
3.10 Afternoon Tea
3.40 Endotoxin test concerns of biologics
• Risk – historical and modern
• Emerging perspective on pyrogenicity vs.
immunogenicity
• Issues
• LPS: Levels – Types – Treatments
• Dosing and Co-Administration of Non-Biologics
Kevin Williams, Senior Scientist,
Lonza QC Testing Solutions
4.20 Cleanrooms to clinic – managing microbiology of stem
cell manufacture
• Background to the stem cell manufacture process
(case study)
• Microbial test considerations during the manufacture of
stem cell therapeutics
• Managing the risk of out of specification results
Thomas Caws, QC Associate, ReNeuron Group plc
5.00 Chairman's Closing Remarks and Close of Day One
Hyglos is dedicated to innovation in Endotoxin Detection & Endotoxin Removal. Based on recombinant reagents, our methods
are entirely animal-free without using Horseshoe crabs. The results generated with EndoLISA®, EndoZyme® and Endo-RS®
convince customers from biopharmaceutical research and industry, overcoming limitations of currently used methods,
including Low Endotoxin Recovery (LER). www.hyglos.com
Lonza QC Testing Solutions: Lonza supports the critical needs of your QC laboratory by supplying endotoxin detection reagents,
equipment, consumables, in addition to the WinKQCL™ Endotoxin Detection and Analysis Software. Complementary to the
endotoxin detection portfolio, Lonza offers MODA™, a robust informatics platform enabling paperless QC processes for
environmental monitoring, product testing, and trending. www.lonza.com/lal
Merck Millipore - a division of Merck KGaA- is a leading supplier to the global life science industry, offering a broad range of
innovative products and services used in the research, development and production of biotech and pharmaceutical drugs
through its three business units. www.merckmillipore.com
3. Pharmaceutical Microbiology
Day Two | Thursday 21st January 2016
Case Studies in Pharmaceutical Microbiology
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Francesco Boschi, Microbiological Services Manager,
GSK Manufacturing S.p.A.
9.10 Sterility case studies and management perspectives
• Learn about case studies provided on specific sites
• Sharing experience on personal site visits and remarks
on issues
• How to prevent contamination events
• The importance of correct training and management
Olivier Chancel, Sterility and Aseptic Process Assurance
Expert, Merial Sas
9.50 Risked-based contamination control and environmental
monitoring in sterile product manufacturing
• Control strategies for sterile product manufacturing;
expected new requirement for EU GMP Annex 1
• Best practice in contamination control for Aseptic
processing of different product types
• Risk based environmental monitoring of manufacturing
environments
James Drinkwater, Chairman of PHSS Pharmaceutical &
Healthcare Sciences Society, PHSS
10.30 Morning Coffee
11.00 Assessment methods for accurate determination of
microbial contamination during clean room manufacture
• Microbial contamination in the cleanroom
• Quantification of risk by airborne deposition
• Quantification of risk by surface contact and liquids
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
11.40 Current practices in disinfectant validation and starting up
a cleanroom after a worst case event
• Best practice for cleaning and disinfection of
cleanroom operations
• Elements of disinfectant validation will be covered
including coupon studies
• Starting up a new cleanroom operation and how to
address cleanroom excursions will be covered
Jim Polarine, Technical Service Manager, STERIS
Corporation
12.20 Networking Lunch
1.40 Afternoon Chair Opening Remarks
Salome Giao, Reseach Scientist, Dyson Technology Ltd
Sterility VBNCs and Biofilms
1.50 Bioburden test of bulk solutions before sterilising filtration:
Current practices and expectations
• Scope and limitations of bioburden test on bulk
solutions before sterilisation
• Regulatory Documents and Guidelines on bioburden
• Bioburden test by “conventional” microbiological
methods: key issues to obtain reliable and significant
• Microbial identifications from bioburden test samples
and evaluation of the recovered flora
• Bioburden test by Rapid Microbiological Methods
Francesco Boschi, Microbiological Services Manager,
GSK Manufacturing S.p.A.
2.30 Risk analysis and mitigation of the analysis process of
sterility testing in an isolator environment
• False positive” sterility tests are a major concern for
business continuity
• A non-zero percentage Sterility test failure rate is a
Regulatory Auditor topic which can be avoided
• How to use FMEA as a tool to reduce risk of “false
positives”implmentation of risk mitigation and it’s
influence on sterility test failure rate
Hans Noordergraaf, Microbiologist, Abbott Biologicals B.V.
3.10 Afternoon Tea
3.40 Controlling and monitoring contamination in water for
pharmaceutical use (WPU)
• Reflecting on how to avoid any contamination of your
installation by a bio burden
• Explaining the regulatory framework exists and is
increasingly demanding as WPU can come into direct
or indirect contact with the drug administered to the
patient
• Water contamination case studies and monitoring
Robert Neri, Water for Pharmaceutical Use Referent,
Sanofi Pharma
4.20 The viable but non-cultivable (VBNC) state of pathogens:
A myth or reality?
• VBNC as a controversial and ignored state
• Why do cells undergo VBNC?
• Are VBNC virulent?
• New methods to detect VBNC cells: an urgent need
Salome Giao, Reseach scientist, Dyson Technology Ltd
5.00 Chairman's Closing Remarks and Close of Day Two
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4. HALF-DAY PRE-CONFERENCE WORKSHOP A
Tuesday 19th January 2016
9.15am - 12.20 pm
Holiday Inn Kensington Forum, Central London, UK
Spectrometric and Optical Technologies
for Microbial Contamination Control
Leader:
Andrew Bartko, Research Leader, Battelle
Overview of workshop:
The workshop will begin with a review the scientific foundation
of spectrometric and optical methods that are used for
sensing microbes. Fundamental principles will be discussed
and related to microbial attributes being interrogated. The
Pros and Cons of the methods will be discussed with respect
to traditional microbial quality control methods. Finally, the
practical aspects of implementation, validation, and
regulatory considerations will be discussed.
Why should delegates attend this workshop:
• Synopsis of Rapid Microbial Methods options to the
industry
• Technical description of optical sensing of biological
materials
• Advantages and limitations of contamination sensing
• Barriers to implementation
• Comparison to traditional methods
8.30 Registration and coffee
9.00 Opening remarks and introductions
9.15 Session 1 - Sensing Fundamentals
• Optical and mass spectrometry
• Fluorescence, Vibrational, Absorption and
Raman Spectroscopy
• Mass spectrometry
10.00 Coffee
10.15 Session 2 - Utilization of Spectrometric Methods in
Pharmaceutical Production
• Advantages and Limitations of New Methods
• Comparisons to Traditional Microbial Quality Control
11.00 Coffee
11.15 Session 3 - Implementation
• Pitfalls when Implementing Rapid Methods
• Regulatory Considerations
12.20 End of Workshop
About workshop leader:
Dr. Andrew Bartko received a B.S. from the University of
Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. His
graduate work consisted of deciphering spatially
heterogeneous relaxation dynamics of glass forming systems
using novel rotational single molecule microscopy techniques.
In 2002, Dr. Bartko joined the Softmatter Nanotechnology and
Advanced Spectroscopy Team at Los Alamos National
Laboratory where he studied the ultrafast photophysics of
semiconducting quantum dots. Dr. Bartko is a senior scientist in
Battelle’s Technology Development Group where he
contributes to several applied spectroscopy efforts that focus
on biological and chemical sensing. Dr. Bartko is the manager
and technical leader of an interdisciplinary team that is
developing Battelle’s Resource Effective Bioidentification
System (REBS). Rapid microbial sensing capabilities of REBS
have been shown to have practical and strategic importance
where rapid, accurate and precise microbial contamination
control is required. Dr. Bartko has developed several rapid
microbial control applications for industries such as defense,
security and industrial market sectors.
About the organisation:
Every day, around the world, the people of Battelle work at
the forefront of scientific innovation to solve what matters
most for our government and commercial clients.
We create new products, new processes, new technologies
- even new industries. We take breakthrough research from
theory to market-ready products and services that save lives,
meet growing energy demands, protect the environment,
and create competitive advantage. We reach into the future
for discoveries that improve the quality of life for millions here
and now.
Battelle is making the world healthier by solving critical
challenges in public health, improving the performance of
medical devices and helping pharmaceutical companies
get new therapies to market quickly and safely. We work with
government and commercial clients to condense
development timelines and to accelerate innovation in
health and life sciences.
5. HALF-DAY PRE-CONFERENCE WORKSHOP B
Tuesday 19th January 2016
1.00pm - 4.40pm
Holiday Inn Kensington Forum, Central London, UK
Endotoxin Testing: Hot Topics and New
Methods in the European Pharmacopoeia
Leaders:
Karolina Hedd, Director Marketing & Sales, Hyglos GmbH
Holger Grallert, Head of R&D, Hyglos GmbH
Overview of workshop:
This workshop will provide the fundamental
knowledge on the latest technological and
regulatory developments regarding the analysis of
endotoxin in pharmaceutical products and pharma
production environments. Furthermore the underlying
mechanisms of Endotoxin Masking (Low Endotoxin
Recovery, LER) in pharmaceutical formulations will be
explained as well as the newly developed sample
preparation methods.
Why should delegates attend this workshop:
• Quality Control and Production professionals from
pharmaceutical and biotech industries
• R&D pharma and biotech, especially new drug
formulation development
• Research Institutes and Universities
Programme
1.00 Registration and Refreshments
1.30 Session 1
The recombinant factor C (rFC) test
– new method in the European
pharmacopoeia
•Introduction BET and Pyrogen Test Methods
•New Ph. Eur. chapter 5.1.10
2.10 Session 2
Implementation of the rFC test in a routine
service laboratory
•Endotoxin testing under GMP
•Bioanalytical Method Validation
of the rFC test
2.50 Afternoon Tea
3.20 Session 3
Endotoxin Detection of Biologics I
– What are Masking Effects?
•Endotoxin structure and activity
•Impact on detection systems
•Masking of endotoxin (LER)
4.00 Session 4
Endotoxin Detection of Biologics II
– Demasking Endotoxin with dedicated
sample preparation
•Demasking protocol development
•Implementation of demasking method -
case studies
•Regulatory requirements
4.40 Closing Remarks
About the workshop leader:
Karolina Heed studied chemistry and economics in
Gothenburg Sweden and Florence Italy. Prior to
heading the marketing & sales of Hyglos GmbH, Ms.
Heed worked almost 10 years in the biotech industry
in different roles.
About the organisation:
Hyglos GmbH is a leading biotech company offering
highly innovative technology for removal and
detection of Endotoxins, located in Biotechnology
Center Bernried, Munich area, Germany. Being an
IAFP Safety Innovation Awardee we apply our
proprietary technology for developing highly specific
bacteriophage-derived proteins for improved
detection and removal of harmful bacteria and
bacterial toxins such as Lipopolysaccharides (LPS).
Hyglos was founded in 2009 and fulfils all
development and production requirements
according to ISO 9001 and 13485.
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PHARMACEUTICAL MICROBIOLOGY
Conference: Wednesday 20th & Thursday 21st January 2016, Holiday Inn Kensington Forum, London, UK
Workshops: Tuesday 19th January 2016, Holiday Inn Kensington Forum, London, UK
4 WAYS TO REGISTER
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