This document provides information on the Pharmaceutical Microbiology West Coast conference happening June 17-19, 2020 in San Diego. It outlines the chairs, speakers, highlights and agenda for the event. The conference will focus on novel approaches and best practices for tackling current industry contamination control challenges, and will include sessions on contamination control, guidance and regulations, detection and identification methods, and supporting pharmaceutical facilities and novel therapeutics. There will also be an optional pre-conference workshop on data integrity in environmental monitoring.
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
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
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.
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
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!
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!
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
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.
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
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!
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!
Biomanufacturing in China: Technologies and Facility DesignRita Barry
Join us as we DISCOVER, ANALYZE and LEARN the current state of the global biomanufacturing industry and the future growth potential and recent developments in Asia.
Some of the Key Highlights You Won’t Want to Miss Include
USA
Smart & Flexible Manufacturing Solutions in Multi-Product Facilities
Franz Walz, Executive Director Global Manufacturing, Science and Technology & Network Coordination, BOEHRINGER INGELHEIM
EUROPE
MAb Manufacturing Facilities for China & Automated Single-Use Processing to Bring Control & Flexibility to Manufacturing
Pauline Nicholson, Global Product Manager, Allegro Single-Use Systems, PALL
Niels Guldager, Senior Technology Partner, NNE PHRAMAPLAN
KOREA:
How to Bring Global Biopharmaceutical Capability through its Fully-Integrated Production Facilities?
Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS
SINGAPORE
What do Investors Look for When Investing in Biologics Manufacturing?
Steven Lee, Global Head of Biologics Tech Operations & Managing Director, DR. REDDY'S LABORATORIES
INDIA
Developing a Multiproduct Facility for Biosimilars & Engineering & Biomanufacturing of Enzymes for Different Applications
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals,
CADILLA PHARMACEUTICALS
Ravindra Wagh, Vice President, ZYDUS BIOLOGICS
Rajeev Soni, Senior Manager, R&D, NOVOZYMES
HONGKONG
What are the Experiences & What is the Future for the Investors in the Biomanufacturing Space?
Ramesh Rajentheran, Head of Asian Healthcare Investment Banking, BARCLAYS
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT
INDONESIA
Improving Quality Control & Maintenance of Global Biological Product Distribution
Galatia Chandra, Head of Sales & System, Global Operation, KALBE INTERNATIONAL PTE LTD
http://www.biomanufacturing-asia.com
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.
Lighting Rockets at the UChicago Microbiome LaunchpadLaura Berry
Presented at the 5th Microbiome R&D and Business Collaboration Forum: USA. To find out more, visit:
www.global-engage.com
With the recent gift of $100 million, the Duchossois Family Institute was established, providing UChicago with the resources to develop models for translating microbiome research. Matt Martin discusses their plans for expanding the support provided to faculty and the mechanisms for launching their startups and technologies.
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SMi Group's Pharmaceutical Microbiology West Coast 2020 conference
1. www.pharma-microbiology-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
CHAIRS FOR 2020:
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
Geeta Singh, Plant and Network Technical Specialist III,
Genentech
SPEAKERS FOR 2020:
• Scott Weiss, Director, Industrial Microbiology, Johnson &
Johnson
• Ren-Yo Forng, Scientific Director, Amgen
• Lynne Ensor, VP, Technical, Parexel
• Chinmoy Roy, Senior Industry Consultant, Valgensis Inc.
• Stephen Langille, Senior Microbiology Consultant, ValSource
• Ronaldy Maramis, QC Supervisor, Microbiology, Bristol-Myers
Squibb
• Mike Bauman, Associate Director, QC, Seattle Genetics
• Timothy Wood, President, Principal Consultant, Cell Therapy
Microbiology Consulting
• Rachael Relph, Chief Sustainability Officer, My Green Lab
• Carol Davis, Manager, QC Microbiology and Biology, Grifols
• Lynn Johnson, Senior Scientist, Takeda
• Ziva Abraham, President, Microrite
• Morgan Polen, SME, Cleanroom Contamination Control
Expert, Microrite
HIGHLIGHTS FOR 2020:
• Discuss the guidance, regulations and case studies for
objectionable organisms in non-sterile drug products from
ValSource, Inc.
• Gain insight into changing paradigms – moving to in-process
testing from Johnson & Johnson
• Examine alternative endotoxin test methods for products
exhibiting LER from Amgen
• Explore how to effectively scale up from clinical to
commercial in three moves from Bristol-Myers Squibb
• Join us for our first All-Women Panel Discussion on ‘Culturing’
successful women microbiologists
WORKSHOP: 17TH
CONFERENCE: 18TH – 19TH
JUNE
2020HYATT REGENCY MISSION BAY HOTEL, SAN DIEGO, USA
Novel approaches and best practices for tackling current
industry contamination control challenges
SMi Presents The 4th Annual Conference on…
Pharmaceutical
Microbiology West Coast
SMi Pharma
@SMiPharm
#SMiPharmaMicroWC
SPONSORED BY
PLUS AN INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOP | WEDNESDAY JUNE 17TH, 2020, HYATT REGENCY MISSION BAY HOTEL, SAN DIEGO, USA
Data Integrity in Environmental Monitoring: Causes and Solutions
Workshop Leaders:
Ziva Abraham, President, Microrite
Morgan Polen, SME, Cleanroom Contamination Control Expert, Microrite
13.30 - 17-30
BOOK BY 28TH FEBRUARY AND SAVE $400
BOOK BY 29TH MARCH AND SAVE $200
BOOK BY 30TH APRIL AND SAVE $100
2. Pharmaceutical Microbiology West Coast
DAY ONE | Thursday June 18, 2020 www.pharma-microbiology-usa.com
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
CONTAMINATION CONTROL
OPENING PRESENTATION
9.10 Building a Global Contamination Control Program
• Creating the global framework
• Network implementation, emphasizing the collaboration
between global and site partners
• Embedding sustainability and continuous improvement into the
program
• Sharing lessons learned and best practices
Lynn Johnson, Senior Scientist, Takeda
9.50 Cleanroom Pass Through Best Practices
• Utilizing Sanitizers for Pass Thru Decon
• Compelling New Data with a Sporicide followed by a Sanitizer
• Controlling fungal and bacterial spores in Cleanrooms
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
10.30 Morning Coffee
MICRORITE SPOTLIGHT PRESENTATION
11.00 Non-viable particle monitoring: Myths, mistakes and
consequences
• Common errors make in choosing particle monitoring devices
• Standards and regulations related to particle monitoring
• A glimpse into macro particle descriptor-why 5 micron particles
are important
• Mistakes made during particle monitoring-volume vs particles
• When do particle monitoring devices become a source of
contamination
Morgan Polen, SME, Cleanroom Contamination Control Expert,
Microrite
11.40 Paper Based Compliance versus Factual Contamination Control
• Case studies related 483 observations and warning letters
resulting from paper based compliance mindset
• Level of risk appetite and risk tolerance by management;
common reasons and consequences
• Reasons why paper-based compliance fails
• Lack or loss of knowledge base a common problem
• Group exercise on paper-based compliance vs factual science-
based risk assessment
Ziva Abraham, President, Microrite
12.20 Networking lunch
13.20 ALL-WOMEN PANEL DISCUSSION: ‘Culturing’ Successful
Women Microbiologists
• Supplementing Your Microbiology Education and Training:
Additional Resources for Microbiology Careers in Industry
• Optimally Highlighting Your Pharmaceutical Microbiology
Experience
• Microbiology Careers Providing Balance of Work and Personal
Life
• Building Your Own Colony: Microbiology Networking for Success
• Expanding Beyond a Microbiology-centric Focus: Recognizing
Signals for Change
Moderator:
Lynne Ensor, VP, Technical, Parexel
Panel members:
Carol Davis, Manager, QC Microbiology and Biology, Grifols
Lynn Johnson, Senior Scientist, Takeda
Ziva Abraham, President, Microrite
Geeta Singh, Plant and Network Technical Specialist III,
Genentech
14.20 One-Hour Mycoplasma Testing by Anyone,
Anywhere, Anytime
Sylvanie Cassard Guilloux, Global Solution Manager,
bioMérieux
15.00 Afternoon Tea
15.30 Sterility sample size considerations for cellular therapies
• Rationale for the appropriate sterility sample size for cell and
gene therapy products
• Ensuring the sterility test samples are appropriate for the
materials tested, scientifically sound and representative of the
batch while preserving sufficient product for patients
• Meeting regulatory expectations
Timothy Wood, President, Principal Consultant, Cell Therapy
Microbiology Consulting
16.10 Container closure integrity testing
• FDA guidance and expectations on container closure integrity
testing
• USP <1207> and different probabilistic and deterministic
methods
• Case Studies and potential pitfalls
Carol Davis, Manager, QC Microbiology and Biology, Grifols
16.50 Chair’s Closing Remarks and Close of Day One
Register online at www.pharma-microbiology-usa.com
MARKETING PARTNERSHIP OPPORTUNITIES
SMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profile, add value,
create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering?
Contact Simi Sapal, Marketing Manager on +44 (0) 20 7827 6000 or email: ssapal@smi-online.co.uk
OFFICIAL MEDIA PARTNERS:
3. Pharmaceutical Microbiology West Coast
DAY TWO | Friday June 19, 2020 www.pharma-microbiology-usa.com
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Geeta Singh, Plant and Network Technical Specialist III,
Genentech
GUIDANCE AND REGULATION
OPENING PRESENTATION
9.10 Objectionable Organisms in Non-Sterile Drug Products –
Guidance, Regulations, and Case Studies
• Definition of an objectionable organism
• Guidance, standards and regulations relating to non-sterile
products
• Prevention of objectionable organism contamination
• Case studies related to objectionable organisms in non-sterile
products
• Burkholderia cepacia complex
Stephen Langille, Senior Microbiology Consultant, ValSource
DETECTION AND IDENTIFICATION
KEYNOTE PRESENTATION
9.50 Changing the Paradigm – Moving to In-Process Release
Testing
• Problems of culture-based methods
• What’s holding us back?
• Benefits of real time monitoring
Scott Weiss, Director, Industrial Microbiology, Johnson & Johnson
10.30 Morning Coffee
11.00 Alternative endotoxin test methods for products exhibiting low
endotoxin recovery
• The development of a suitable method to replace current
endotoxin testing methods for products
• A strategic approach to the evaluation and validation of testing
methods
• The future for finding a suitable replacement method – scope
and reality check
Ren-Yo Forng, Scientific Director, Amgen
11.40 The challenge of viable but nonculturable (VBNC) bacteria:
Induction, Detection, and Control
• A short history and current definitions of the VBNC state of
bacteria
• Natural occurrence, active induction and resuscitation; What
triggers the VBNC state in bacteria and what is the potential
risk?
• Live, Death and in Between; Methods and tools to detect VBNC
and the current state on defining legal limits
• Stress-resistance of VBNC bacteria as an explanation for
recurring contamination; What are effective cleaning and
disinfection measures?
Patrick-Julien Mester, Postdoctoral Research Assistant, Group
Leader, Christian-Doppler Laboratory for Monitoring of Microbial
Contaminants, University of Veterinary Medicine, Vienna
12.20 Networking lunch
FACILITY SUPPORT AND NOVEL THERAPEUTICS
13.20 How a Lab Scaled Up in 3 Moves
• Lessons learned from taking laboratory operations from clinical
to commercial setting
• Lessons learned from sustaining laboratory operations for
commercial setting
Ronaldy Maramis, QC Supervisor, Microbiology,
Bristol-Myers Squibb
14.00 CASE STUDY: Executing rapid transition from clinical to
commercial manufacturing
• Navigating through phase-appropriate cGMP
• Demonstrating acceptable data integrity and management
• Exploring the use of rapid technologies
Mike Bauman, Associate Director, QC, Seattle Genetics
14.40 Afternoon Tea
15.10 Emphasis on laboratory data integrity deficiencies and
compliance
• Frequency of non-compliant regulatory findings and FDA
warning letters
• Reassessing the definitions of data integrity and the current
analytical and statistical methods to detect anomalies
• Conducting a Laboratory Data Integrity Risk Assessment using
Process Flow Charts
• Risk-based case studies showcasing multiple approaches
Chinmoy Roy, Senior Industry Consultant, Valgensis Inc.
15.50 Our Sustainable Future: Integrating Sustainability into Operations,
R&D, and Manufacturing
• A growing movement in laboratory sustainability: Green Lab
certification
• Sustainability integration in laboratory operations, R&D and drug
manufacturing
• Benefits in time, cost and environmental impact
• Current techniques that align with sustainable best practices,
such as RMM
• Case Studies and recommendations for implementation to your
current lab
Rachael Relph, Chief Sustainability Officer, My Green Lab
16.30 Chair’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
SUPPORTED BY:
4. HALF-DAY PRE-CONFERENCE WORKSHOP
WEDNESDAY JUNE 17TH, 2020 | 13.30 – 17.30
HYATT REGENCY MISSION BAY HOTEL, SAN DIEGO, USA
DATA INTEGRITY IN ENVIRONMENTAL MONITORING: CAUSES AND SOLUTIONS
Overview:
Data integrity issues related to media fills or environmental monitoring often are symptoms
of a larger problem, poor cleanroom / barrier system design, integration or operational
practices. EM and Media fill data integrity often begins with poorly executed Smoke
Studies. As poorly designed and implemented cleanroom/barrier systems can not reliably
and repeatably meet the viable/non-viable limits established in cGMP. Poor air flow in
aseptic manufacturing can create a situation where random EM excursions are blamed
on operators and companies are forced to falsify data in order to meet production
schedules. Often these design flaws would be identified in a comprehensive static and
dynamic smoke study. Instead Regulatory observations and warning letters related to
environmental monitoring are not new; however, observations related to smoke studies,
cleanroom/barrier system design flaws are also indicative of an unsuitable environmental
monitoring or fraudulent environmental monitoring data.
Why you should attend:
The current regulatory thinking related to risk-based monitoring and utilizing smoke study
data for identifying these sample locations indicates that regulators are aware of the
prevalence of data integrity in environmental monitoring. The scrutiny regulators place
on smoke studies is evident in 483 observations as well as warning letters. Learn about the
various aspects of pragmatic and scientific risked-based environmental monitoring that
identifies real world risk and weaknesses in system design.
• Pragmatic risk assessment is science based not an exercise
• Understanding Real-world risks verse perceived risks
• Common Cleanroom/barrier system design flaws that lead to data integrity situations
• Air flow visualization, The most misunderstood and under utilized tool for aseptic
operations.
• Learn from the mistakes of others, Case studies will be provided.
About the Workshop leaders:
Ziva Abraham is the President and Founder of Microrite, Inc., a California based
consulting firm providing consulting and training services to pharmaceuticals,
biotechnology, medical devices and in vitro diagnostics in the areas of quality
assurance, quality control, microbiology, and validation. Ziva has over 25 years
of academic, research, clinical and industrial experience in microbiology,
and quality assurance. Ziva has received her Master’s Degree in microbiology with a
focus on Mycology and has conducted research on developing microbial insecticides
using entomogenous bacteria and fungi for her PhD degree. Her career also includes
founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained
personnel from various industries in microbiology techniques and methods. She uses her
extensive experience to teach why assessing risk of microbial contamination should be in
the forefront of any company that has products for human/veterinary use. Her experience
in clinical laboratories has provided her with the framework to understand the effects of
microbial contamination in products from a patient safety perspective.
Morgan Polen has been involved with cleanrooms and contamination control
since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring
programme development, particle counter design and product management for cleanroom related products and systems. He has addressed
monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage,
aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and
Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.
Programme:
13.30 Registration & Coffee
14.00 Opening remarks and introductions
14.10 Session 1
• Understanding the current expectations related
to environmental monitoring
• Why facility design issues may result in unsuitable
airflows, which can become a cause of data
integrity during monitoring to avoid consistent
excursions
• Propagated myths about smoke studies that is
leading to data integrity by choosing incorrect
sites
• Why smoke studies are the best tools to select risk
based sites
14.50 Session 2
• Common cleanroom and barrier system design
flaws that lead to data integrity in environmental
monitoring
• Template based environmental monitoring
procedures vs risk based monitoring program
• Understanding the standards and guidance’s
related to monitoring
15.30 Afternoon Tea
16.00 Session 3
• Choice of particle counters-key to accurate
qualification and monitoring
• Active air samplers- learn the science to get
accurate recovery
• Media issues that can result in slow or no growth
• Reading environmental monitoring plates-
mistakes commonly made
16.40 Session 4
• Trending-the key to assessing patient risk
• Why lack of clinical microbiology knowledge fails
in assessing patient risk
• Why most CAPAs related to EM excursions are
just a paper exercise if science is not applied for
the start
17.20 Closing remarks
17.30 End of workshop
Workshop Leaders:
Ziva Abraham, President, Microrite
Morgan Polen, SME, Cleanroom Contamination Control Expert, Microrite
Register online at www.pharma-microbiology-usa.com
PHOTOS FROM PHARMACEUTICAL MICROBIOLOGY SERIES
Engage with top microbiologist in our
microbiology focused conference
Network with Industry & Pharma
Leaders in the Exhibition Area
Head from over 20 presentations on
the contamination control, microbial
detection and environmental
monitoring
5. SMi’S PHARMACEUTICAL MICROBIOLOGY INFOGRAPHIC: WEST COAST
ATTENDEE GEOGRAPHY:
COMPANY BREAKDOWN
NETWORKING
JOB TITLE BREAKDOWNBREAKDOWN OF ATTENDEE BY SENIORITY:
80% Pharma
45% Microbiologist
20% Project
manager
2% Head/Chief
6% Founder/
President/CEO
8% Founder/President/CEO 11% Director
11% Head/Chief
36% Project
Manager
61% Director
20% Industry/
Solution
Providers
5+Hours of
Dedicated
Networking this
year
100+Industry Microbiology
Professionals attended last
year’s event
PHARMACEUTICAL EAST COAST
CONFERENCE
29 - 30 APRIL 2020
Boston, MA, USA
85% USA
6% Canada
1% Germany
1% Luxembourg
2% France
2% UK
3% ROW
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, Director, on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
ACC Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape
Cod, Inc. (ACC) has been a leader in endotoxin and (1g3)-ß-D-glucans detection products
and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA
licensed company to manufacture LAL reagents. www.acciusa.com/acc/index.html
bioMérieux, Inc. helps our clients unlock greater value from their organizations with expert
consultation and a complete line of diagnostic solutions that enable more rapid, confident results.
Clients benefit from improved productivity and profitability by minimizing errors and reducing time
to result, as well as brand protection and safer and healthier consumer products.
www.biomerieux-usa.com/biopharma
Bioscience International The newest generation of SAS microbial air monitors, for ensuring full
compliance with ISO 14698, cGMP and other international monitoring guidelines will be displayed.
www.biosci-intl.com
Microcoat offers a wide range of individual and specialized services for pharmaceutical industry.
In close cooperation with our customers, we aim for best performance building on a complete
range of advanced technologies and uncompromised quality standards. Based on long lasting
experience in endotoxin and pyrogen testing, Microcoat offers a set of methods (bacterial
endotoxin testing and monocyte activation test) and skilled scientific personnel for investigation
and resolving of low endotoxin recovery, non-routine projects and routine release measurements
under GMP conditions. Services are run as flexible customer-specified projects including the
search for root causes, exploration of realization alternatives, development of product-specific
adaptions, and validation of newly established methods. We support customers in the selection
and establishment of testing strategies for challenging samples and biopharmaceuticals in line
with regulatory guidelines. www.microcoat.de
MilliporeSigma is a top player in industrial microbiology and process monitoring providing state-
of-the-art testing methods, regulatory expertise, and outstanding service to provide that one
invaluable result: maintaining the safety of your products. The portfolio includes hardware,
consumables, validation, and method development for bioburden, sterility, environmental
monitoring, and media fill.
www.emdmillipore.com/US/en/products/industrial-microbiology/3Vyb.qB.B4YAAAE_0AZ3.
Lxj,nav
PROUDLY SPONSORED BY:
Register online at www.pharma-microbiology-usa.com
SAVE THE DATE
6. PHARMACEUTICAL MICROBIOLOGY WEST COAST 2020
Conference: 18th - 19th June 2020, Hyatt Regency Mission Bay Hotel, San Diego, USA Workshop: 17th June 2020, Hyatt Regency Mission Bay Hotel, San Diego, USA
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
ONLINE at www.pharma-microbiology-usa.com
POST your booking form to: Events Team, SMi Group Ltd,
India House, 45 Curlew Street, London, SE1 2ND
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-322 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 30-00-09, Account 11775391
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 11775391
IBAN GB75 LOYD 3000 0911 7753 91
□ Cheque We can only accept USD checks Drawn on a US Bank.
□ Credit Card □ Visa □ MasterCard □ American Express
SMi Group will apply surcharges to commercial cards
Please tick here □ if the card provided is not a commercial card
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I agree to be bound by SMi’s Terms and Conditions of Booking.
Card Billing Address (If different from above):
I cannot attend but would like to Purchase access to the following Document
Portal/Paper Copy documentation. Price Total
Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
□ Book by 28th February to receive $400 off the conference price
□ Book by 29th March to receive $200 off the conference price
□ Book by 30th April to receive $100 off the conference price
EARLY BIRD
DISCOUNT
VAT at 20% is charged on Document Portal Literature Distribution for all UK Customers
and for those EU Customers not supplying a registration number for their own country here
______________________________________________________________________________________
PAYMENT
VAT
DOCUMENTATION
CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE
I would like to attend: (Please tick as appropriate) TOTAL
□ Conference 1 Workshop $2498.00
□ Conference only $1999.00
□ 1 Workshop only $499.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject
to distribution rights by speakers. Please note that some presentations may not be
available for download. Access information for the document portal will be sent to
the e-mail address provided during registration. Details are sent within 24 hours post
conference.
Unique Reference Number
Our Reference P-322
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
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ACCOUNTS DEPT
Title: Forename:
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Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of event require payment on booking. Access to the Document Portal will not be given until
payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send
a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at lWest 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifically to order. If we
have to cancel the event for any reason, then we will make a full refund immediately, but disclaim
any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
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updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out
Terms and Conditions of Booking
DELEGATE DETAILS
VENUE Hyatt Regency Mission Bay Hotel, San Diego, USA
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712