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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
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:
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:
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
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
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
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PHONE on +44 (0) 870 9090 711
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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. 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