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 companyās 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 Chairās 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 Genentechās 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 Chairās 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 Chairās 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 Companyās 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 Chairās 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
Bachelorās degree in Molecular Biology from State University of
New York at New Paltz, and a Masterās 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 yearās direct industry experience including
the design, build, start-up, and management of facilities,
specializing in aseptic manufacturing. Mr. Fererās 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 PDAās microbial investigations task force. He was
a co-author on PDAās 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 worldās 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
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www.microbiologyeastcoast.com
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