This document provides information on the Pharmaceutical Microbiology USA conference happening on June 7-9, 2017 in San Diego. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. It will feature presentations and panel discussions from industry experts on topics like challenges in microbial control, environmental monitoring trends, rapid microbial testing validation, data integrity, and contamination issues. Attendees can choose from pre-conference workshops on technologies for monitoring contamination control or microbial required use for terminal sterilization. The conference aims to evaluate the latest trends and opportunities in microbial control for pharmaceutical manufacturing.
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
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
Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Gain an in-depth insight into endotoxin testing, validation and LER. Understand the threats posed by VBNCs and how to detect them.
For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
Book by 30th October and save £200!
Book by 30th November and save £100!
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
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
Program - American Chemical Manufacturing Summit 2013, PittsburghMark Blendheim
The American Chemical Manufacturing Summit brings together industry leaders to discuss the current state of the industry and the impact of new regulations. The summit provides chemical manufacturing, quality and supply chain executives valuable insight into new manufacturing strategies, technology and Operational Excellence.
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Stra...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ClosedSamplingWebinar
Sampling should never put your process or sample at risk of contamination resulting in loss of time, money or regulatory scrutiny. This webinar discusses simple and effective sampling options to implement a secure sampling operation across your entire process driving towards closed manufacturing.
Explore our webinar library: www.emdmillipore.com/webinars
Everyday Lessons from Extraordinary Circumstances.
The business decisions we make often have unforeseen, far-reaching effects wholly unrelated to its original intent.
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Gain an in-depth insight into endotoxin testing, validation and LER. Understand the threats posed by VBNCs and how to detect them.
For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
Book by 30th October and save £200!
Book by 30th November and save £100!
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
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
Program - American Chemical Manufacturing Summit 2013, PittsburghMark Blendheim
The American Chemical Manufacturing Summit brings together industry leaders to discuss the current state of the industry and the impact of new regulations. The summit provides chemical manufacturing, quality and supply chain executives valuable insight into new manufacturing strategies, technology and Operational Excellence.
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Stra...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ClosedSamplingWebinar
Sampling should never put your process or sample at risk of contamination resulting in loss of time, money or regulatory scrutiny. This webinar discusses simple and effective sampling options to implement a secure sampling operation across your entire process driving towards closed manufacturing.
Explore our webinar library: www.emdmillipore.com/webinars
Everyday Lessons from Extraordinary Circumstances.
The business decisions we make often have unforeseen, far-reaching effects wholly unrelated to its original intent.
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
PuppetConf 2016: Automating Datastore Fleets with Puppet – Joseph Lynch, YelpPuppet
Here are the slides from Joseph Lynch's PuppetConf 2016 presentation called Automating Datastore Fleets with Puppet. Watch the videos at https://www.youtube.com/playlist?list=PLV86BgbREluVjwwt-9UL8u2Uy8xnzpIqa
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
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.
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.
Gathering a room of Senior Scientists and Heads of Pharmaceutical Engineering, the 5th annual show provides an ideal forum to discuss the latest advancements in pharmaceutical lyophilisation, welcoming regulatory guidance from the NIBSC-MHRA and expertise from the likes of Sanofi, Boehringer Ingelheim, Roche, Novo Nordisk and more!
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
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?
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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.
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.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
SMi Group's Pharmaceutical Microbiology USA 2017 conference
1. KEY BENEFITS FOR 2017:
• Discuss the challenges involved with microbial control with
Takeda
• Following the path to efficient sterility assurance with GSK
• Bimeda highlight the importance of environmental modelling
• Delve into the latest developments in rapid microbial
methods with Janssen
• Hear the latest on data integrity and compliance with Roche
SMi present the 7th in its series...
Hyatt Regency Mission Bay, San Diego, USA
Pharmaceutical
Microbiology USA
Addressing the current challenges in sterility assurance, environmental monitoring
and RMM whilst evaluating the latest trends and opportunities for microbial control.
WORKSHOPS: 7TH
CONFERENCE:
8TH - 9TH
JUNE
2017
REGISTER BY 28TH FEBRUARY AND SAVE $300
REGISTER BY 31ST MARCH AND SAVE $200
REGISTER BY 28TH APRIL AND SAVE $100
www.pharma-microbiology-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE @SMIPHARM
#smimicrobiology
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS
Wednesday 7th June 2017, Hyatt Regency Mission Bay, San Diego, USA
Technologies for Monitoring Contamination Control
and Case Studies on Contamination Control
08.30 – 12.30
Workshop Leaders:
Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation
Andrew Bartko, Research Leader, Battelle Memorial Institute
Microbial Required Use for
Terminal Sterilization
13.30 – 17.30
Workshop Leader:
Jerry Dalfours, Principal, JD Technologies
Sponsored by
CHAIRS FOR 2017:
• Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK
• John Duguid, Senior Director, Research & Development,
Vericel Corporation
EXPERT SPEAKER PANEL INCLUDE:
• Ron Smith, Director, External Supply Integration Quality, Janssen
• Ren-Yo Forng, Scientific Director, Amgen
• Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda
• Lina Orjuela, Microbiologist, Merck
• Paul Ricciatti, Sterility Assurance Manager, Bimeda
• Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
• Akua Gilbert-Arthur, Principal Scientist,
Roche Molecular Systems
2. Pharmaceutical Microbiology USA
Day One | Thursday 8th June 2017 www.pharma-microbiology-usa.com
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK
OPENING ADDRESS
09.10 Retracing the path to sterility assurance: An USP journey
• Update on latest revisions of USP microbiology chapters
• Discussion of work activities for revising chapter on sterility
assurance
• Current thinking about sterile product evaluation topics
(bacterial endotoxins testing, alternative pyrogen test,
container closure integrity evaluation, sterility test)
Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK
ENVIRONMENTAL MONITORING
09.50 The importance of environmental monitoring
• Environmental monitoring in today’s pharmaceutical
industry is imperative to avoid potential risks to consumers
and to save time and cost to manufacturers
• Rules governing dispersion of airborne microbial
contaminants and how contaminants can accumulate
in invisible vortices and airborne contamination
• How to evaluate representative sampling locations for
environmental monitoring during aseptic processes
Paul Ricciatti, Sterility Assurance Manager, Bimeda
10.30 Morning Coffee
11.00 Environmental monitoring trend analysis tools
• The importance of proper analysis and evaluation of
viable EM results.
• Development of a “tool box” in order to produce
specialized data reports.
• A case study in using the correct tools to demonstrate
environmental control in a cleanroom environment
Steve Walton, Technical Manager, Sterility Assurance,
Sanofi
11.40 Gram negative LPS structural alterations in response to
environmental stimuli
• Overview of how gram negative bacteria adapt to
various environmental conditions
• The role of modulation of outer membrane components
has on facilitating environmental adaptation
• The effect of external stimuli and structural adaptation
has on the classical LPS architecture
John Dubczak, Director of Operations,
Charles River
12.20 Networking Lunch
CHALLENGES IN ENDOTOXIN RECOVERY & STERILITY ASSURANCE
13.20 Challenges in endotoxin testing
• Advantages of in-process control
• Issues occurring in the detection of endotoxins
• Utilising the alternative endotoxin reagents and/or
methods to detect potential contaminants in products
Ren-Yo Forng, Scientific Director, Amgen
14.00 Interactive extended training session:
Effects of cleanrooms and barrier systems
on environmental monitoring data
Recent warning letters show that manufacturers of aseptic
products are receiving the most 483s; many are related
to smoke studies. Smoke / Airflow Visualization tests are
often performed by third party certifiers. However, per
FDA guidance, dynamic in-situ air pattern analysis is
more complex. These studies should be investigative and
effective at identifying design flaws or airflow issues. They
should be performed using the correct type of smoke,
smoke density, and camera angles.
• A closer look at existing regulation
(e.g. Pharm. Eur., USP, PDA)
• Why do we need to implement rapid microbial
methods vs classical microbial methods?
• How to evaluate the best RMM for each application
• Validation strategy, regulatory strategy and examples
of return of experiences
Morgan Polen, Subject Matter Expert on Contamination
Control, Microrite
15.00 Afternoon Tea
15.30 Bringing the cleanroom online after an adverse event
• Environmental control of classified areas within a
biopharmaceutical facility - maintained by systems
controlling humidity, air temperature, air exchanges,
filtration and pressure differentials
• When any of these systems or practices fail, it’s
considered a “Worst Case Event” which has the potential
to impact the clean state of a Classified Area
• FDA Warning Letters and 483s will be covered that focus
on cleanroom shut down and start up procedures
Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
16.10 Microbiological examination of non-sterile products
• Experience with USP <61> and USP <62> tests
• Utilising these test to provide harmonization with the
European Pharmacopeia methods
• Challenges incurred and lessons learnt
Elizabeth Hulanick, Microbiologist, Renaissance
Pharmaceuticals
16.50 Chairman’s Closing Remarks and Close of Day One
Sponsored by
Register online at www.pharma-microbiology-usa.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Charles River
Protecting the integrity of your products requires a reliable partner at all critical junctures in the QC process. We’ve purposely built our
portfolio to bring you progressive products and services that deliver accurate, relevant and reliable data to fuel confident decisions
on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial
detection and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and
smoothly,lowersyourcosttomanufactureandprotectsyourreputation. www.criver.com/products-services/manufacturing-support
Rapid Micro Biosystems delivers the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration
technology based on the compendial method for microbial quality control in pharmaceutical manufacturing. The system
automates and accelerates detection and enumeration in the areas of environmental monitoring, bioburden and sterility testing
eliminating manual steps and analysis. The Company’s Growth DirectTM System detects contamination earlier, delivering compelling
economic benefits to manufacturers, while improving their quality process. The Growth Direct System is the first and only automated
system that addresses all key microbial QC applications and fits with current regulatory practices, a critical accelerator for adoption.
Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers
to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering significant cost savings
and increased operational efficiency. www.rapidmicrobio.com
3. Pharmaceutical Microbiology USA
www.pharma-microbiology-usa.com Day Two | Friday 9th June 2017
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
John Duguid, Senior Director, Research & Development,
Vericel Corporation
RAPID MICROBIAL METHODS
OPENING ADDRESS
09.10 Challenges involved with microbial control
• A CMO-focused microbial control strategy
• The challenges with managing an external
manufacturing program
• Looking to the future
Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda
09.50 Validation of a Rapid Microbial Method: Case studies for
microbial limits and sterility testing.
• Overview of the approach for testing equivalence of a
qualitative method
• Demonstrating equivalence to pour plate method for
Microbial Limits testing of betamethosone suspension
• Demonstrating equivalence to membrane filtration
sterility test method for a saline product
Ronald Smith, Director, External Supply Integration Quality,
Janssen
10.30 Morning Coffee
11.00 US approval of three rapid microbiological methods for
MACI product release
• Same day product release is needed for MACI®
(autologous cultured chondrocytes on porcine collagen
membrane)
• Automated rapid microbiological methods enable test
results within hours
• Regulatory requirements are continuing to evolve
John Duguid, Senior Director, Research & Development
Vericel Corporation
DATA INTEGRITY
11.40 Data integrity and compliance
• Current limitations with data integrity
• How to improve the reliability of data is necessary
to support clinical trials, product development and
manufacturing, and testing and reporting requirements
• Examining data integrity in relation to related to
pharmaceutical microbiology, including environmental
monitoring and laboratory analysis
Akua Gilbert-Arthur, Principal Scientist,
Roche Molecular Systems
12.20 Networking Lunch
13.20 Lessons learned in microbial data integrity management
• Data integrity within analytical and microbiology
laboratories for all phases of the drug product lifecycle
• What works well? How can it be improved?
• Examining the recently released draft guidance data
integrity and compliance with CGMP guidance for industry
Lina Orjuela, Microbiologist, Merck
BIOFILMS & OTHER CONTAMINANTS
14.00 Additional background on biofilm, its impacts in
healthcare, her discovery, and current testing.
• We are losing the war on bacteria. One of the reasons is
biofilm -- the sticky substance that bacteria form in order
to attach to surfaces and then shield the developing
colony from environmental stresses
• It is no coincidence that every bacterium on the lists
of the Center for Disease Control are biofilm-formers:
urgent threats (C. diff, etc.), pandemic threats
(pneumonia, T.B., E.coli, Salmonella, Listeria, cholera,
plague, etc.), bioterror threats (anthrax, etc.),, and
antimicrobial-resistant strains (MRSA, MDR-TB, CRES, etc.)
• As biofilm builds it captures other bacteria, and there is
evidence of horizontal gene transfer between different
species
• There are few remedies for biofilm. Scraping and
sterilization work, but they are short term. Biofilm was
recorded on a titanium plate within 30 seconds after
sterilization
• The human immune system, biocides and antibiotics are
designed to kill free-floating bacteria. Nothing known
can remove pre-formed biofilm at non-lethal doses
Cynthia Burzell, Founder & CSO, Aequor, Inc.
14.40 Afternoon Tea
15.10 Challenges with contamination issues
• Mold - A simple method to eliminate and prevent mold
anywhere.
• Biofilm - Simple and fast methods to eliminate and
prevent biofilm
• Spores - Simple ways to eliminate quickly and safe for
your equipment/surfaces
Brian Hubka, CEO, BGH International, LLC
15.50 Common errors in microbial identification and implications
• Phenotypic vs. Genotypic systems-capabilities and
deficiencies
• Deficient media quality control
• Microbiology laboratory training deficiencies that lead
to errors
• Growth media and incubation errors
• Gram staining errors
• What to do when in doubt
• Case studies
Ziva Abraham, CEO, Microrite
16.30 Chairman’s Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
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Supported byOfficial Media Partners:
4. Overview of the workshop:
This session will discuss pathways to use the data obtained from
environmental monitoring to provide proactive and practical
solutions for comprehending and managing everyday
pharmaceutical microbiology challenges. This presentation will
cover case studies on human flora and spore contamination
in cleanroom operations. The workshop will cover the most
common causes of contamination: operators, items brought
into the cleanroom, and degradation of the cleanroom over
time. Case studies in operator borne contamination will be
discussed as well as preventative long term solutions. Targeted
long term solutions will be discussed regarding the spore case
studies in a concerted effort to limit reoccurrences. The overall
objective and scope of this seminar will be to discuss specifi c
cases studies that have occurred in my years of experience
in the industry. The concepts of cleaning and disinfection,
application frequency, disinfectant rotation, and rinsing and
residue removal strategies will be covered as well.
Why should you attend this workshop:
This industry workshop will give attendees valuable insight into
the world of contamination control and troubleshooting fungal
and bacterial spore excursions in cleanrooms. Attendees will
gain new insight into common causes of CAPA investigations
which will cut down on time that is invested finding potential
causes for contamination which can cost an organization 50K
per investigation.
Programme
08.30 Registration & Coffee
09.00 Opening remarks & introductions
09.15 Introduction
• Conventional methods
• Limitations
09.45 Sensing fundamentals
• Absorption and fluorescence
• Vibrational and Raman spectroscopy
• Mass spectrometry
10.30 Morning Coffee
11.00 Utilisation of spectrometric methods
• Advantages and limitations of new methods
• Comparisons to traditional microbial quality control
11.30 Industry case studies
• Vegetative organisms
• Fungal spores
• Bacterial spores
12.15 Interactive exercise
12.30 End of workshop
About the Workshop Leaders:
Mr. Polarine is a senior technical service manager
at STERIS Corporation. He has been with STERIS
Corporation for sixteen years. His current technical
focus is microbial control in cleanrooms and other
critical environments. He is active as co-chair on the PDA’s
microbial investigations task force. He was a co-author on
PDA’s Technical Report #70 on Cleaning and Disinfection. He
is a member of the PDA’s Environmental Monitoring Group,
Contamination Control Group, and Biotech Interest Group.
Dr. Andrew P. Bartko received a B.S. from the
University of Pittsburgh in 1997 and a Ph.D. in physical
chemistry in 2002. 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 Bioidentifi
cation System (REBS).
About the Organisation:
STERIS is a global leader in infection
prevention, contamination control,
surgical and critical care technologies,
and more. STERIS is the world’s pre-eminent infection
prevention, decontamination, and surgical and critical care
company. Every day, the people of Battelle apply science
and technology to solving what matters most. At major
technology centers and national laboratories around the
world, Battelle conducts research and development, designs
and manufactures products, and delivers critical services for
government and commercial customers.
Technologies for Monitoring
Contamination Control and Case Studies
on Contamination Control
Workshop Leaders: Jim Polarine Jr, Senior Technical
Service Manager, STERIS Corporation and Andrew Bartko,
Research Leader, Battelle Memorial Institute
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 7th June 2017
08.30 – 12.30
Hyatt Regency, Mission Bay, San Diego, CA
5. Overview of the workshop:
Determining best way to work with Microorganisms to ensure
we have sterilization that verifies we have no patient risk or
product stability issues due to survival of the microorganism
or damage to the product due to sterilization.
Why should you attend this workshop:
Knowing how to most effectively establish your D-values,
Z-values, F-values and Fbio-values along with Fo, FH and
lethality based on your bioburdens and any biological
indicator you select to use in your process based on the
variables associated with so many different issues associated
with different products that all need to be proven to be
sterile prior to distribution.
Programme
13.30 Registration & Coffee
14.00 PNSU – BIOBURDEN – Probability Function D values,
Z values and Fo
• How were those established?
• Where Did “Fo” start relative the microbial
impact
• Microbiological D value variations
• Can’t typically use what the vendor provides for
D values and Z values based on your product
trying to be sterilized.
• Typical BI Death Curve and Fraction Negative
• D121 value, Z value and Determination of Fo
• Bioburden Monitoring and determination of
potential sterilization risk compared to any
biological indicator
15.30 Afternoon Tea
16.00 Recent FDA Sterilization Observations Resulting
in Warning Letters – Providing what the FDA has
written about a variety of different situations that
has caused significant concerns based on many
companies not having the correct perspective
about Microbiological Sterilization.
17.20 Closing remarks
17.30 End of workshop
About the Workshop Leader:
Mr. Jerry Dalfors has extensive (40+ years) of
business administration, consultative, technical
and managerial experience in the development
and manufacture of highly regulated
biopharmaceutical products including injectables,
biologics, medical devices and oral dosages. He has held
permanent employee, temporary employee and company
representative management positions with a multitude of
the major pharmaceutical and biotechnology companies in
the US. He has worked with or assisted more than two dozen
companies with the establishment of controlled document/
qualitysystems,FDAbriefingandsubmittaldocuments,project
management of several multimillion dollar projects including
design, start-up and validation to assure fast track FDA
approval by maintaining strict regulatory compliance during
all phases of engineering, construction, commissioning and
validation, and has written numerous submission documents
for product, process and facility approval/licensing which also
required the development of quality systems which included
customer complaint management, deviation management,
CAPA and associated site wide employee training. Each of
his projects have been received and accepted by the FDA
and other regulatory agencies. Jerry is considered and expert
in most all aspects of the biopharmaceutical and medical
device industry and has trained many FDA field inspectors on
a variety of topics. None of his work has ever received a 483
but has corrected and prevented many along with Warning
Letter remediation.
About the Organisation:
JD Technologies provides consulting, regulatory and
documentation support to the pharmaceutical and
biopharmaceutical industries. JD Technologies prides itself
on being able to succesfully carry a project from concept to
completion, and integrating with other company employees
and contractors in a team effort.
Microbial Required Use for
Terminal Sterilization
Workshop Leader:
Jerry Dalfours, Principal, JD Technologies
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 7th June 2017
13.30 – 17.30
Hyatt Regency, Mission Bay, San Diego, CA
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VENUE Hyatt Regency, Mission Bay, San Diego, CA, USA
PHARMACEUTICAL MICROBIOLOGY USA
Conference: Thursday 8th & Friday 9th June 2017, Hyatt Regency, Mission Bay, San Diego, CA, USA Workshop: Wednesday 7th June 2017, San Diego, CA, USA
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