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B: Contamination Control
in Cleanrooms
13.30 - 17.30
Workshop Leader:
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
www.microbiologyeastcoast.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
#SMiMicroEast
A: Navigating the requirements of a modern QC
Microbiology Laboratory
08.30 - 12.30
Workshop Leaders:
Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist,
Quality Executive Partners, Inc. and Robert Ferer, Consulting Partner / Strategic
Practice Lead, Quality Executive Partners, Inc.
HIGHLIGHTS IN 2017:
ā€¢ Learn more about Rapid Microbial Methods, Microbe
Interaction and Stability Testing by implementing a Microbial
Control Strategy to avoid failure
ā€¢ Listen to in depth presentations about Environmental
Monitoring, its challenges of avoiding risks and how to monitor
and control microbial containment
ā€¢ Expand your knowledge on Contamination Control and how to
identify and improve this by learning from various case studies
presenting different solutions
ā€¢ Gather expert insight on different methods for Bacterial
Endotoxin Testing, including a case study on Low Endotoxins
Recovery strategies
SMi present the 8th in its series...
Pharmaceutical
Microbiology East Coast
Discussing best practises for rapid microbial and sterility
testing and tackling the challenges of contamination control
CONFERENCE:
13TH - 14TH
WORKSHOPS: 15TH
NOV
2017
CHAIR FOR 2017:
ā€¢ Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
KEY SPEAKERS INCLUDE:
ā€¢ Joseph Chen, Executive Director, CMC Quality Control,
Ultragenyx Pharmaceutical
ā€¢ Geeta Singh, Pilot Plant Technical Specialist III, Genentech
ā€¢ Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
ā€¢ Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi
ā€¢ Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly
ā€¢ David Huang, Chief Medical Officer, Motif Bio
ā€¢ Andrew Bartko, Research Leader, Battelle Memorial Institute
Sponsored by
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
BOOK BY 30TH JUNE 2017 AND SAVE $300
BOOK BY 29TH SEPTEMBER 2017 AND SAVE $100
Register online at www.microbiologyeastcoast.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your companyā€™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
For over 30 years, Charles River has helped customers bring products to market safely and efficiently with
revolutionary technologies and exceptional services that have changed the way we conduct microbial
quality control. Continuing with a passion to innovate and respond to customersā€™ needs, our Microbial Solutions
group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems
of CelsisĀ®. Joining the trusted brands of EndosafeĀ® endotoxin testing and AccugenixĀ® microbial identification,
CelsisĀ® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any
single provider. www.criver.com/microbialsolutions
Sponsored by
08.30	 Registration & Coffee
09.00	 Chairā€™s Opening Remarks
	Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
MICROBIAL CONTROL STRATEGIES AND QUALITY METHODS
	 OPENING KEYNOTE ADDRESS:
09.10	 The Role of Microbiology in Pharmaceutical Stability Programs
	 ā€¢	Stability Study Requirements: RD versus Marketed Products
	 ā€¢	What Microbial Tests are Stability Test Parameters
	 ā€¢	Stability Testing Appropriate for Different Dosage Forms
	 ā€¢	Managing the Stability Commitments in your Regulatory Filings
	 ā€¢	Investigating Stability Test Failures
	Tony Cundell, Principal Consultant,
Microbiological Consulting, LLC
09.50	How does a Non-GMP Biopharmaceutical Pilot Facility deliver
high run rate with high success?
	 ā€¢	CHO and E. coli process development overview
	 ā€¢	Provide an overview of the premier Pilot Plant facility in Biotech
USA that executes more than 1500 CHO and E. coli experiments
per year to support Genentechā€™s pipeline
	 ā€¢	Discuss microbial contamination case studies and the lessons
learned
	 ā€¢	Discuss how critical it is to maintain good health of the non-GMP
facility to achieve high success rate
	 Geeta Singh, Pilot Plant Technical Specialist III, Genentech
10.30	 Morning Coffee  Networking Break
11.00	Amplified ATP Bioluminescence Rapid Sterility Test Validation
Utilizing a Defined Method for Stressing Microorganisms
	 ā€¢	Provides an efficient, and reproducible method for generating
log reductions in microbial cultures
	 ā€¢	Comparative data / illustrations shall be presented to
demonstrate stressing procedural efficacy
	 ā€¢	The impact of stressed organisms on Time to Detect,
and Limit of detection shall be demonstrated
	 Shawn Sweeney, Senior Process
	 Development Manager, Charles River
11.40	 Deciphering the Host-Microbe Interaction
	 ā€¢	The microbiome is implicated in several chronic disorders
	 ā€¢	The metabolites produced by the microbes are chemical
messengers interacting with host receptors
	 ā€¢	Studying this interaction will have important knowledge building
around disease pathologies
	 Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
12.20	 Networking Lunch
ENVIRONMENTAL MONITORING TO AVOID POTENTIAL RISKS
13.30	Benefits of Real-time Monitoring of Airborne Viable
Microorganisms
	 ā€¢	Bio-fluorescent active air particle counting of airborne viable
microorganisms
	 ā€¢	Continuous real-time Environmental Monitoring of Classified
Environments
	 ā€¢	Risk mitigation
	 James Hauschild, Principal Scientist, Johnson  Johnson
14.10	Current Expectations for a Complete Environmental Monitoring
Program
	 ā€¢	Increasing expectations for non-sterile manufacturers
	 ā€¢	Types of functions that should be included in the program -
besides monitoring
	 ā€¢	What is required in these functions
	 ā€¢	How to put the system together
	Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
14.50	Microbial Environmental Control Assessment using Microbial
Recovery Trends
	 ā€¢	Microbial Recovery rate trend analysis is stated by USP 1116
to evaluate microbial control levels in aseptic process areas
	 ā€¢	Microbial Recovery rates trend analysis has demonstrated being
an excellent toll to determine the efficiency of microbial control
corrective actions
	 ā€¢	The purpose of this presentation is to review the results of our
assessment in classified areas
	Angel Salaman, Principal Process Scientist, Janssen Biotech
15.30	 Afternoon Tea  Networking Break
BACTERIAL ENDOTOXIN TESTING AND LER STRATEGIES
16.00	 Quality Control Strategy on Low Endotoxins Recovery (LER)
	 ā€¢	Discuss common formulation ingredients in biologics cause LER
	 ā€¢	Risk assessment approach in mitigating LER impact on product
quality
	 ā€¢	Case study on analytical solution to LER and alternatives
	Joseph Chen, Executive Director, CMC Quality Control,
Ultragenyx Pharmaceutical
16.40	 Method Development
	 ā€¢	How to determine the Maximum Valid Dilution (MVD)
	 ā€¢	Endotoxin inhibition / enhancement
	 ā€¢	How to determine endotoxin limits on raw materials and
excipients
	 Josephine Chan, Microbiology Supervisor, Teligent Pharma Inc.
17.20	 Chairā€™s Closing Remarks and Close of Day One
Pharmaceutical Microbiology East Coast
Day One | Monday 13th November 2017 		 www.microbiologyeastcoast.com
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Kyra Williams, SMi Marketing on +44 (0) 207 827 6012 or email: kwilliams@smi-online.co.uk
08.30 Registration  Coffee
09.00 Chairā€™s Opening Remarks
Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
CONTAMINATION CONTROL AND STERILITY ASSURANCE
OPENING ADDRESS:
09.10 Implementation of a Risk Based Model for Cleaning and
Disinfection
ā€¢Development of a risk based model for cleaning and
disinfection
ā€¢Using a risk model for room recovery following an adverse event
ā€¢Implementation strategy for introducing a risk based cleaning
and disinfection regimen
Steve Walton, Technical Manager, Sanofi Pasteur
09.50 Contamination Challenges
ā€¢Combatting Mold: Introducing a simple method to eliminate
and prevent mold anywhere
ā€¢Discussing fast and simple methods to eliminate and prevent
biofilm
ā€¢Easy ways to eliminate spores quickly and safely for your
equipment/surfaces
Brian Hubka, CEO, BGH International
10.30 Morning Coffee  Networking Break
11.00 Training of Media Fill Inspection Operators
ā€¢Training Program Overview
ā€¢Creation of Positive Containers
ā€¢Test/Inspection Conditions
ā€¢Certification of Operators
ā€¢Recertification/Retraining ā€“ Frequency and Basis
Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi
KEYNOTE ADDRESS
11.40 Implementation of a Global Electronic Intervention Logging System
Sterility is one of the most critical quality attributes that all
parenteral products must possess; yet, it is one of the most difficult
to consistently and convincingly demonstrate. This presentation
discusses an integrated, cross-functional strategy implemented
within Eli Lilly and Companyā€™s parenteral manufacturing network.
This strategy identifies, assesses, documents, and evaluates the
single largest source of microbial hazard within aseptic filling areas
ā€“ aseptic personnel.
ā€¢This presentation will describe an Aseptic Manipulation and
Intervention Program, which establishes the requirements for
how aseptic interventions and manipulations are identified,
assessed, and executed
ā€¢This presentation will describe the Intervention Logging System
which allows for real-time electronic documentation and
approval of non-coded interventions performed on aseptic
filling lines
ā€¢This presentation will describe the use of RFID for
documentation of Electronic Signature for activities within the
aseptic areas
Collectively, these provide quantifiable information that helps
mitigate the risk of personnel-induced microbial hazard of
products filled in aseptic environments.
The attendees will understand the importance of developing
a robust intervention strategy with appropriate definitions of
activities. Additionally, identifying, assessing and mitigating all
aseptic interventions and manipulations allow for consistent
evaluation of filler performance across a platform.
Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly
12.20 Networking Lunch
RAPID MICROBIAL DETECTION AND DESIGNED THERAPIES
13.30 Rapid microbial-detection methods
ā€¢The benefits, applications, pitfalls and challenges involved
ā€¢Time to result benefits to manufacturing economics
ā€¢Enhanced quality control impact on manufacturing risk
ā€¢Overcoming the hurdles of new technology validation
Andrew Bartko, Research Leader, Battelle Memorial Institute
14.10 Designed microbiome therapies targeting the microbes and beyond
ā€¢The gut microbiome plays an essential role in disease regulation
and efficacy of therapies. Altered microbial communities, also
termed dysbiosis, has been observed in many intestinal and
extra-intestinal inflammatory disorders
ā€¢There is not yet a clear understanding whether dysbiosis is a
cause or a consequence of the diseases. Microbial therapies
which only target the dysbiosis have shown limited success
ā€¢A healthy gut microbiota exists in an equilibrium with the gut
barrier and the immune system
ā€¢The importance of multiple-target drug cocktails comprising
commensal bacteria will be discussed. The bacterial library,
screening technologies and design of potential and affordable
drugs will be presented with particular focus on successful
products that treat Irritable Bowel Syndrome (IBS) and
Clostridium Difficile Infection
Shahram Lavasani, Founder  CEO, ImmuneBiotech AB
14.50 Afternoon Tea  Networking Break
15.20 Iclaprim, a novel diaminopyrimidine, for the treatment of serious
Gram-positive infections
ā€¢Iclaprim addresses an unmet medical need in hospitalized
patients with serious and life threatening infections including MRSA
ā€¢Iclaprim possesses a differentiated product profile in target
patient populations
ā€¢Iclaprim provides a near-term product opportunity
David Huang, Chief Medical Officer, Motif BioSciences
16.00 Biological Treatment of Emerging Contaminants Prevalent in
Pharmaceutical Efļ¬‚uents
ā€¢Pharmaceutical wastewater commonly consists of
contaminants of emerging concerns, such as antibiotics,
estrogens, and 1,4-dioxane
ā€¢Bacteria that can degrade or biotransform these xenobiotic
compounds are more widespread than previously recognized
ā€¢Modern culture-independent biotechnologies facilitate the
identification of microorganisms with unique biotransformation
capabilities
ā€¢Biologically active filtration system is one of top effective and
economical techniques for removal of commingled emerging
contaminants in pharmaceutical waste streams
Mengyan Li, Assistant Professor, New Jersey Institute of Technology
16.40 Chairā€™s Closing Remarks and Close of Day Two
Pharmaceutical Microbiology East Coast
www.microbiologyeastcoast.com Day Two | Tuesday 14th November 2017
Supported byOfficial Media Partners:
A: Navigating the requirements of a
modern QC Microbiology Laboratory
Overview of the workshop:
This workshop will introduce ideas for blending traditional
microbiology with the cutting edge methodologies that are
available to the industry, both inside the laboratory and on the
manufacturing floor for routine monitoring programs. It will also
provide practical approaches for common laboratory issues
surrounding implementation of alternative technologies, data
integrity and analyst training.
Why you should attend:
This workshop is designed to inspire and motivate the attendee
for understanding the evolution of microbiological methods in
pharmaceutical manufacturing, and basic expectations for
building quality into the product.
Programme
08.30 Registration  Coffee
09.00 Opening Remarks
09.10 Session 1 - The Modern Microbiology Lab
ā€¢ Learn about current trends in QC Microbiology
ā€¢ Solutions for when to upgrade technology in your lab
09.50 Session 2 - Real Time Release Testing
ā€¢ Learn about options available for monitoring water
 products in real time
ā€¢ Discuss the creation and application of new
excursion criteria
10.30 Morning Coffee
11.00 Session 3 - Data Integrity in a Digital Lab
ā€¢ Application of data integrity for conventional 
alternative lab methods
ā€¢ Practical approaches  safeguards against
common mistakes
11.40 Session 4 - The iMicrobiologist
ā€¢ Blending old  new technologies in the QC
Microbiology lab
ā€¢ Understanding, hiring  training the new
generation of talent
12.20 Closing Remarks
12.30 Close of Workshop
About the workshop leaders:
Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist
and Consulting Partner, has more than 12 years combined
experience in Pharmaceutical, Biotechnology and Medical
Device industries. Mrs. Figueroa has expertise in sterility
assurance, environmental and utilities monitoring programs
and quality control laboratory management. Her consulting
experiences have spanned both domestic and international
large pharmaceutical companies, applying both US and
global regulatory standards of quality. Mrs. Figueroa has a
Bachelorā€™s degree in Molecular Biology from State University of
New York at New Paltz, and a Masterā€™s degree in Molecular
Biology and Microbiology from San Jose State University. She
is an active and contributing member of several professional
organizations, such as the Parenteral Drug Association,
American Society of Microbiology and Association for Women
in Science.
Robert Ferer, Engineering Chemist and Consulting Partner
with more than 28 yearā€™s direct industry experience including
the design, build, start-up, and management of facilities,
specializing in aseptic manufacturing. Mr. Fererā€™s experience
covers all aspects of pharmaceutical operations from receipt
of raw materials through inspection, final packaging, and
shipping of finished products. As a consultant, he is frequently
contracted to manage large-scale projects and provide
high-level strategy and goal definition to clients. This includes
due diligence, facility audits, compliance, and regulatory
guidance for North America as well as EU markets. Mr. Ferer
has a Bachelors degree in Engineering Chemistry from the
State University of New York at Stony Brook and is a contributing
member of both the International Society of Pharmaceutical
Engineers and the Parenteral Drug Association.
About the company:
At Quality Executive Partners (QxP), our mission is to bring
bold revolution to quality consulting. We are fueled by the
passion for doing what is right and being the much needed
disruptive innovation! The QxP team is comprised of executives
with extensive track records delivering successful outcomes
in situations of intense regulatory scrutiny. Our executives
have substantial experience interacting and negotiating
with FDA and other global regulatory agencies. We take a
pragmatic, strategic view of internal processes, quality system
development, and implementation of key matters.
Workshop Leaders:
Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical
Microbiologist, Quality Executive Partners, Inc.
Robert Ferer, Consulting Partner / Strategic Practice Lead,
Quality Executive Partners, Inc.
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 15th November 2017
08.30 ā€“ 12.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
B: Contamination Control
in Cleanrooms
Overview of the workshop:
Staying ahead of the curve with Contamination Control
requires an understanding and an anticipation of the
constantly changing microbial climate of the pharmaceutical
manufacturing process. Knowing the characteristics of the
environments in that process provides the benefit of allowing
us to predict and solve potential future microbial control issues.
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 workshop will
cover case studies on human flora and spore contamination in
cleanroom operations. Solutions will be discussed to proactively
present future contamination issues.
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. Specific examples of aerobic
and anaerobic vegetative bacteria will be highlighted and
analyzed. Items brought into cleanrooms that can harbor
fungal and bacterial spores will be discussed as well as specific
case studies highlighting examples where sources were items
brought into the cleanroom or in some cases other common
causes. Fungal and bacterial spore structures as well as efficacy
testing and specific test conditions will be covered. Solutions
will be presented to prevent efficacy testing failures due to test
method, recovery, and coupon porosity issues. 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 workshop will be to
discuss specific cases studies that have occurred in my years of
experience in the industry. Specific long term solutions will be
conveyed to prevent reoccurrences and yield higher levels of
control in the cleanroom operations. The concepts of cleaning
and disinfection, application frequency, disinfectant rotation,
and rinsing and residue removal strategies will be covered in
complete detail 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
13.30 Registration  Coffee
14.00 Opening Remarks and Introductions
14.10 Session 1 - Common Sources of Contamination:
Case Studies
14.50 Session 2 - A Risk Based Cleaning and
Disinfection Program
15.30 Afternoon Tea
16.00 Session 3 - Key Elements of a Successful
Disinfectant Validation Program
16.40 Session 4 - Bringing the Cleanroom Online After
a Worst-Case Event
17.20 Closing Remarks
17.30 Close of Workshop
About the workshop leader:
Mr. Polarine is a senior technical service manager at STERIS
Corporation. He has been with STERIS Corporation for seventeen
years. His current technical focus is microbial control in
cleanrooms and other critical environments. He has lectured in
North America, Europe, Middle East, Asia, and Latin America on
issues related to cleaning and disinfection in cleanrooms. Mr.
Polarine is a frequent industry speaker and published several
PDA book chapters and articles related to cleaning and
disinfection and contamination control. He is active as co-
chair on the PDAā€™s microbial investigations task force. He was
a co-author on PDAā€™s Technical Report #70 on Cleaning and
Disinfection. Mr. Polarine graduated from the University of Illinois
withaMasterofArtsinBiology. Hepreviouslyworkedasaclinical
research coordinator with the Department of Veterans Affairs in
St. Louis, MO and as a biology and microbiology instructor at the
University of Illinois. His main hobby is storm chasing and is very
active in tornado research and tornado safety.
About the organisation:
STERIS is a global leader in infection prevention, contamination
control, surgical and critical care technologies, and more.
STERIS is the worldā€™s pre-eminent infection prevention,
decontamination, and surgical and critical care company.
Workshop Leader:
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 15th November 2017
13.30 ā€“ 17.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
PHARMACEUTICAL MICROBIOLOGY EAST COAST
Conference: Monday 13th  Tuesday 14th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshops: Wednesday 15th November 2017, New Jersey, USA
4 WAYS TO REGISTER
www.microbiologyeastcoast.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd,
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Contamination Control in Cleanrooms Workshop

  • 1. B: Contamination Control in Cleanrooms 13.30 - 17.30 Workshop Leader: Jim Polarine, Senior Technical Service Manager, STERIS Corporation PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA www.microbiologyeastcoast.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 #SMiMicroEast A: Navigating the requirements of a modern QC Microbiology Laboratory 08.30 - 12.30 Workshop Leaders: Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners, Inc. and Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners, Inc. HIGHLIGHTS IN 2017: ā€¢ Learn more about Rapid Microbial Methods, Microbe Interaction and Stability Testing by implementing a Microbial Control Strategy to avoid failure ā€¢ Listen to in depth presentations about Environmental Monitoring, its challenges of avoiding risks and how to monitor and control microbial containment ā€¢ Expand your knowledge on Contamination Control and how to identify and improve this by learning from various case studies presenting different solutions ā€¢ Gather expert insight on different methods for Bacterial Endotoxin Testing, including a case study on Low Endotoxins Recovery strategies SMi present the 8th in its series... Pharmaceutical Microbiology East Coast Discussing best practises for rapid microbial and sterility testing and tackling the challenges of contamination control CONFERENCE: 13TH - 14TH WORKSHOPS: 15TH NOV 2017 CHAIR FOR 2017: ā€¢ Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting KEY SPEAKERS INCLUDE: ā€¢ Joseph Chen, Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical ā€¢ Geeta Singh, Pilot Plant Technical Specialist III, Genentech ā€¢ Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline ā€¢ Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi ā€¢ Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly ā€¢ David Huang, Chief Medical Officer, Motif Bio ā€¢ Andrew Bartko, Research Leader, Battelle Memorial Institute Sponsored by Renaissance Woodbridge Hotel, Iselin, New Jersey, USA BOOK BY 30TH JUNE 2017 AND SAVE $300 BOOK BY 29TH SEPTEMBER 2017 AND SAVE $100
  • 2. Register online at www.microbiologyeastcoast.com SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your companyā€™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 For over 30 years, Charles River has helped customers bring products to market safely and efficiently with revolutionary technologies and exceptional services that have changed the way we conduct microbial quality control. Continuing with a passion to innovate and respond to customersā€™ needs, our Microbial Solutions group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems of CelsisĀ®. Joining the trusted brands of EndosafeĀ® endotoxin testing and AccugenixĀ® microbial identification, CelsisĀ® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any single provider. www.criver.com/microbialsolutions Sponsored by 08.30 Registration & Coffee 09.00 Chairā€™s Opening Remarks Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting MICROBIAL CONTROL STRATEGIES AND QUALITY METHODS OPENING KEYNOTE ADDRESS: 09.10 The Role of Microbiology in Pharmaceutical Stability Programs ā€¢ Stability Study Requirements: RD versus Marketed Products ā€¢ What Microbial Tests are Stability Test Parameters ā€¢ Stability Testing Appropriate for Different Dosage Forms ā€¢ Managing the Stability Commitments in your Regulatory Filings ā€¢ Investigating Stability Test Failures Tony Cundell, Principal Consultant, Microbiological Consulting, LLC 09.50 How does a Non-GMP Biopharmaceutical Pilot Facility deliver high run rate with high success? ā€¢ CHO and E. coli process development overview ā€¢ Provide an overview of the premier Pilot Plant facility in Biotech USA that executes more than 1500 CHO and E. coli experiments per year to support Genentechā€™s pipeline ā€¢ Discuss microbial contamination case studies and the lessons learned ā€¢ Discuss how critical it is to maintain good health of the non-GMP facility to achieve high success rate Geeta Singh, Pilot Plant Technical Specialist III, Genentech 10.30 Morning Coffee Networking Break 11.00 Amplified ATP Bioluminescence Rapid Sterility Test Validation Utilizing a Defined Method for Stressing Microorganisms ā€¢ Provides an efficient, and reproducible method for generating log reductions in microbial cultures ā€¢ Comparative data / illustrations shall be presented to demonstrate stressing procedural efficacy ā€¢ The impact of stressed organisms on Time to Detect, and Limit of detection shall be demonstrated Shawn Sweeney, Senior Process Development Manager, Charles River 11.40 Deciphering the Host-Microbe Interaction ā€¢ The microbiome is implicated in several chronic disorders ā€¢ The metabolites produced by the microbes are chemical messengers interacting with host receptors ā€¢ Studying this interaction will have important knowledge building around disease pathologies Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline 12.20 Networking Lunch ENVIRONMENTAL MONITORING TO AVOID POTENTIAL RISKS 13.30 Benefits of Real-time Monitoring of Airborne Viable Microorganisms ā€¢ Bio-fluorescent active air particle counting of airborne viable microorganisms ā€¢ Continuous real-time Environmental Monitoring of Classified Environments ā€¢ Risk mitigation James Hauschild, Principal Scientist, Johnson Johnson 14.10 Current Expectations for a Complete Environmental Monitoring Program ā€¢ Increasing expectations for non-sterile manufacturers ā€¢ Types of functions that should be included in the program - besides monitoring ā€¢ What is required in these functions ā€¢ How to put the system together Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting 14.50 Microbial Environmental Control Assessment using Microbial Recovery Trends ā€¢ Microbial Recovery rate trend analysis is stated by USP 1116 to evaluate microbial control levels in aseptic process areas ā€¢ Microbial Recovery rates trend analysis has demonstrated being an excellent toll to determine the efficiency of microbial control corrective actions ā€¢ The purpose of this presentation is to review the results of our assessment in classified areas Angel Salaman, Principal Process Scientist, Janssen Biotech 15.30 Afternoon Tea Networking Break BACTERIAL ENDOTOXIN TESTING AND LER STRATEGIES 16.00 Quality Control Strategy on Low Endotoxins Recovery (LER) ā€¢ Discuss common formulation ingredients in biologics cause LER ā€¢ Risk assessment approach in mitigating LER impact on product quality ā€¢ Case study on analytical solution to LER and alternatives Joseph Chen, Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical 16.40 Method Development ā€¢ How to determine the Maximum Valid Dilution (MVD) ā€¢ Endotoxin inhibition / enhancement ā€¢ How to determine endotoxin limits on raw materials and excipients Josephine Chan, Microbiology Supervisor, Teligent Pharma Inc. 17.20 Chairā€™s Closing Remarks and Close of Day One Pharmaceutical Microbiology East Coast Day One | Monday 13th November 2017 www.microbiologyeastcoast.com
  • 3. Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 MARKETING OPPORTUNITIES Want to know how you can get involved? Interested in promoting your services to this market? Contact Kyra Williams, SMi Marketing on +44 (0) 207 827 6012 or email: kwilliams@smi-online.co.uk 08.30 Registration Coffee 09.00 Chairā€™s Opening Remarks Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting CONTAMINATION CONTROL AND STERILITY ASSURANCE OPENING ADDRESS: 09.10 Implementation of a Risk Based Model for Cleaning and Disinfection ā€¢Development of a risk based model for cleaning and disinfection ā€¢Using a risk model for room recovery following an adverse event ā€¢Implementation strategy for introducing a risk based cleaning and disinfection regimen Steve Walton, Technical Manager, Sanofi Pasteur 09.50 Contamination Challenges ā€¢Combatting Mold: Introducing a simple method to eliminate and prevent mold anywhere ā€¢Discussing fast and simple methods to eliminate and prevent biofilm ā€¢Easy ways to eliminate spores quickly and safely for your equipment/surfaces Brian Hubka, CEO, BGH International 10.30 Morning Coffee Networking Break 11.00 Training of Media Fill Inspection Operators ā€¢Training Program Overview ā€¢Creation of Positive Containers ā€¢Test/Inspection Conditions ā€¢Certification of Operators ā€¢Recertification/Retraining ā€“ Frequency and Basis Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi KEYNOTE ADDRESS 11.40 Implementation of a Global Electronic Intervention Logging System Sterility is one of the most critical quality attributes that all parenteral products must possess; yet, it is one of the most difficult to consistently and convincingly demonstrate. This presentation discusses an integrated, cross-functional strategy implemented within Eli Lilly and Companyā€™s parenteral manufacturing network. This strategy identifies, assesses, documents, and evaluates the single largest source of microbial hazard within aseptic filling areas ā€“ aseptic personnel. ā€¢This presentation will describe an Aseptic Manipulation and Intervention Program, which establishes the requirements for how aseptic interventions and manipulations are identified, assessed, and executed ā€¢This presentation will describe the Intervention Logging System which allows for real-time electronic documentation and approval of non-coded interventions performed on aseptic filling lines ā€¢This presentation will describe the use of RFID for documentation of Electronic Signature for activities within the aseptic areas Collectively, these provide quantifiable information that helps mitigate the risk of personnel-induced microbial hazard of products filled in aseptic environments. The attendees will understand the importance of developing a robust intervention strategy with appropriate definitions of activities. Additionally, identifying, assessing and mitigating all aseptic interventions and manipulations allow for consistent evaluation of filler performance across a platform. Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly 12.20 Networking Lunch RAPID MICROBIAL DETECTION AND DESIGNED THERAPIES 13.30 Rapid microbial-detection methods ā€¢The benefits, applications, pitfalls and challenges involved ā€¢Time to result benefits to manufacturing economics ā€¢Enhanced quality control impact on manufacturing risk ā€¢Overcoming the hurdles of new technology validation Andrew Bartko, Research Leader, Battelle Memorial Institute 14.10 Designed microbiome therapies targeting the microbes and beyond ā€¢The gut microbiome plays an essential role in disease regulation and efficacy of therapies. Altered microbial communities, also termed dysbiosis, has been observed in many intestinal and extra-intestinal inflammatory disorders ā€¢There is not yet a clear understanding whether dysbiosis is a cause or a consequence of the diseases. Microbial therapies which only target the dysbiosis have shown limited success ā€¢A healthy gut microbiota exists in an equilibrium with the gut barrier and the immune system ā€¢The importance of multiple-target drug cocktails comprising commensal bacteria will be discussed. The bacterial library, screening technologies and design of potential and affordable drugs will be presented with particular focus on successful products that treat Irritable Bowel Syndrome (IBS) and Clostridium Difficile Infection Shahram Lavasani, Founder CEO, ImmuneBiotech AB 14.50 Afternoon Tea Networking Break 15.20 Iclaprim, a novel diaminopyrimidine, for the treatment of serious Gram-positive infections ā€¢Iclaprim addresses an unmet medical need in hospitalized patients with serious and life threatening infections including MRSA ā€¢Iclaprim possesses a differentiated product profile in target patient populations ā€¢Iclaprim provides a near-term product opportunity David Huang, Chief Medical Officer, Motif BioSciences 16.00 Biological Treatment of Emerging Contaminants Prevalent in Pharmaceutical Efļ¬‚uents ā€¢Pharmaceutical wastewater commonly consists of contaminants of emerging concerns, such as antibiotics, estrogens, and 1,4-dioxane ā€¢Bacteria that can degrade or biotransform these xenobiotic compounds are more widespread than previously recognized ā€¢Modern culture-independent biotechnologies facilitate the identification of microorganisms with unique biotransformation capabilities ā€¢Biologically active filtration system is one of top effective and economical techniques for removal of commingled emerging contaminants in pharmaceutical waste streams Mengyan Li, Assistant Professor, New Jersey Institute of Technology 16.40 Chairā€™s Closing Remarks and Close of Day Two Pharmaceutical Microbiology East Coast www.microbiologyeastcoast.com Day Two | Tuesday 14th November 2017 Supported byOfficial Media Partners:
  • 4. A: Navigating the requirements of a modern QC Microbiology Laboratory Overview of the workshop: This workshop will introduce ideas for blending traditional microbiology with the cutting edge methodologies that are available to the industry, both inside the laboratory and on the manufacturing floor for routine monitoring programs. It will also provide practical approaches for common laboratory issues surrounding implementation of alternative technologies, data integrity and analyst training. Why you should attend: This workshop is designed to inspire and motivate the attendee for understanding the evolution of microbiological methods in pharmaceutical manufacturing, and basic expectations for building quality into the product. Programme 08.30 Registration Coffee 09.00 Opening Remarks 09.10 Session 1 - The Modern Microbiology Lab ā€¢ Learn about current trends in QC Microbiology ā€¢ Solutions for when to upgrade technology in your lab 09.50 Session 2 - Real Time Release Testing ā€¢ Learn about options available for monitoring water products in real time ā€¢ Discuss the creation and application of new excursion criteria 10.30 Morning Coffee 11.00 Session 3 - Data Integrity in a Digital Lab ā€¢ Application of data integrity for conventional alternative lab methods ā€¢ Practical approaches safeguards against common mistakes 11.40 Session 4 - The iMicrobiologist ā€¢ Blending old new technologies in the QC Microbiology lab ā€¢ Understanding, hiring training the new generation of talent 12.20 Closing Remarks 12.30 Close of Workshop About the workshop leaders: Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 12 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Mrs. Figueroa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Mrs. Figueroa has a Bachelorā€™s degree in Molecular Biology from State University of New York at New Paltz, and a Masterā€™s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and contributing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science. Robert Ferer, Engineering Chemist and Consulting Partner with more than 28 yearā€™s direct industry experience including the design, build, start-up, and management of facilities, specializing in aseptic manufacturing. Mr. Fererā€™s experience covers all aspects of pharmaceutical operations from receipt of raw materials through inspection, final packaging, and shipping of finished products. As a consultant, he is frequently contracted to manage large-scale projects and provide high-level strategy and goal definition to clients. This includes due diligence, facility audits, compliance, and regulatory guidance for North America as well as EU markets. Mr. Ferer has a Bachelors degree in Engineering Chemistry from the State University of New York at Stony Brook and is a contributing member of both the International Society of Pharmaceutical Engineers and the Parenteral Drug Association. About the company: At Quality Executive Partners (QxP), our mission is to bring bold revolution to quality consulting. We are fueled by the passion for doing what is right and being the much needed disruptive innovation! The QxP team is comprised of executives with extensive track records delivering successful outcomes in situations of intense regulatory scrutiny. Our executives have substantial experience interacting and negotiating with FDA and other global regulatory agencies. We take a pragmatic, strategic view of internal processes, quality system development, and implementation of key matters. Workshop Leaders: Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners, Inc. Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners, Inc. HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 15th November 2017 08.30 ā€“ 12.30 Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
  • 5. B: Contamination Control in Cleanrooms Overview of the workshop: Staying ahead of the curve with Contamination Control requires an understanding and an anticipation of the constantly changing microbial climate of the pharmaceutical manufacturing process. Knowing the characteristics of the environments in that process provides the benefit of allowing us to predict and solve potential future microbial control issues. 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 workshop will cover case studies on human flora and spore contamination in cleanroom operations. Solutions will be discussed to proactively present future contamination issues. 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. Specific examples of aerobic and anaerobic vegetative bacteria will be highlighted and analyzed. Items brought into cleanrooms that can harbor fungal and bacterial spores will be discussed as well as specific case studies highlighting examples where sources were items brought into the cleanroom or in some cases other common causes. Fungal and bacterial spore structures as well as efficacy testing and specific test conditions will be covered. Solutions will be presented to prevent efficacy testing failures due to test method, recovery, and coupon porosity issues. 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 workshop will be to discuss specific cases studies that have occurred in my years of experience in the industry. Specific long term solutions will be conveyed to prevent reoccurrences and yield higher levels of control in the cleanroom operations. The concepts of cleaning and disinfection, application frequency, disinfectant rotation, and rinsing and residue removal strategies will be covered in complete detail 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 13.30 Registration Coffee 14.00 Opening Remarks and Introductions 14.10 Session 1 - Common Sources of Contamination: Case Studies 14.50 Session 2 - A Risk Based Cleaning and Disinfection Program 15.30 Afternoon Tea 16.00 Session 3 - Key Elements of a Successful Disinfectant Validation Program 16.40 Session 4 - Bringing the Cleanroom Online After a Worst-Case Event 17.20 Closing Remarks 17.30 Close of Workshop About the workshop leader: Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for seventeen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co- chair on the PDAā€™s microbial investigations task force. He was a co-author on PDAā€™s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine graduated from the University of Illinois withaMasterofArtsinBiology. Hepreviouslyworkedasaclinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety. About the organisation: STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more. STERIS is the worldā€™s pre-eminent infection prevention, decontamination, and surgical and critical care company. Workshop Leader: Jim Polarine, Senior Technical Service Manager, STERIS Corporation HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 15th November 2017 13.30 ā€“ 17.30 Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
  • 6. PHARMACEUTICAL MICROBIOLOGY EAST COAST Conference: Monday 13th Tuesday 14th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Wednesday 15th November 2017, New Jersey, USA 4 WAYS TO REGISTER www.microbiologyeastcoast.com FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, Ground First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMiā€™s Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: 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 ā€˜shareā€™ a place at an event. Please make separate bookings for each delegate. 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VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. ______________________________________________________________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk ā–” 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 I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total ā–” Access to the conference documentation on the Document Portal Ā£499.00 + VAT Ā£598.80 ā–” The Conference Presentations ā€“ paper copy Ā£499.00 - Ā£499.00 (or only Ā£300 if ordered with the Document Portal) Unique Reference Number Our Reference LVP-261 EARLY BIRD DISCOUNT ā–” Book by 30th June 2017 to receive $300 off the conference price ā–” Book by 29th September 2017 to receive $100 off the conference price DELEGATE DETAILS Terms and Conditions of Booking PAYMENT VAT DOCUMENTATION VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee ā–” Conference 2 Workshops $2897.00 ā–” Conference 1 Workshop A ā–” B ā–” $2398.00 ā–” Conference only $1899.00 ā–” 2 Workshops $998.00 ā–” 1 Workshop only A ā–” B ā–” $499.00 PROMOTIONAL LITERATURE DISTRIBUTION ā–” Distribution of your companyā€™s promotional literature to all conference attendees $1598 + VAT $1917.60 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. 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