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PDA 9th Annual Global Conference on Pharmaceutical Microbiology
Pharmaceutical Microbiology - Lessons from Today and Advice for Tomorrow
October 20-22, 2014 | Bethesda North Marriott | Bethesda, MD
Program Agenda
Sunday, October 19, 2014
4:00 p.m. - 6:00 p.m.
Registration Open
| Foyer C Alcove
Monday, October 20, 2014
7:00 a.m. - 5:30 p.m.
Registration Open
| Foyer C Alcove
7:00 a.m. - 8:00 a.m.
Continental Breakfast
| Foyer E - H
8:00 a.m. - 8:15 a.m.
| Salon D
Welcome and Opening Remarks
Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc., Co-Chair, 9th Annual
Global Conference on Pharmaceutical Microbiology Program Planning Committee
8:15 a.m. - 9:15 a.m.
| Salon D
P1: Opening Keynote Address: Investigation of Norovirus Outbreak
Moderator: Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.
CDC has been investigating many outbreaks of the Norovirus abroad cruise ships in the recent years. A major Part of this
investigation is to oversee and ensure the effectiveness of the sanitization and disinfection of these huge vessels in a very short
period of time. In This session, our presenter will provide us with an overview of these investigations and the protocols used for
sanitization and disinfectant. Many lessons can be learned that can be applied at our pharmaceutical manufacturing facilities.
8:15 a.m. - 9:00 a.m.
Cruising to a Norovirus Vaccine
Jan Vinjé, PhD, Head, National Calicivirus Laboratory, Division of Viral Diseases, Centers for Disease Control
9:00 a.m. - 9:15 a.m.
Q&A/Discussion
9:00 a.m. - 6:45 p.m.
Exhibit Hall Open
| Salon E - H
9:15 a.m. - 10:00 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall
| Salon E - H
POSTER PRESENTATIONS
The following posters will be presented today during refreshment breaks and the networking reception
Direct Identification of Industry Relevant Bacteria and Yeast from Positive BacT/ALERT Media Using the VITEK® MS
Corinne De La Foata, R&D Pharma Expert, bioMerieux
Application of Milliflex® Rapid for Sterility Testing of Antibiotics, Vaccines and Cell Cultures
Beth Brescia, Application Scientist, Rapid Micro Methods, EMD Millipore
Conducting an Endotoxin Matrix Interference and Sample Storage Study Relevant for Manufacturing of a Biologic Product
Ruth Daniels, PhD, Head, Microbiology Operational Technical Support and Manufacturing Science Group, Genzyme – A
Sanofi Company
Single Use Systems in Microbiological Environmental Monitoring
Claudio Denoya, PhD, Senior Applications Scientist/Technology Consultant, Particle Measuring Systems
A New Era for Environmental Monitoring for Viable Particles
Boaz Granot, Field Application Specialist – Biotechnology, TSI Incorporated
Rapid Microbial Method Feasibility Study Recommendation for J&J Biologics Production Process Monitoring
James Hauschild, Principal Scientist, Microbiology, Johnson & Johnson
Poster Presentations Continued
Biofilm Formation & Remediation with USP Pretreatment System: A Case Study
Julie McKinney, PhD, Senior Manager Microbiology & Raw Materials, Pfizer Consumer Healthcare
Development of Bioburden Test Method Suitable for Mammalian Cell Culture Containing Antibiotics
Youwen Pan, PhD, QC Scientist, Genentech, Inc.
Container Closure Integrity Testing – How to Improve an Established Method
Jamie Perkins, Quality Control Scientist, Pfizer, Inc.
The Industry Best Practices in Disinfectant Coupon Testing
James Polarine, Technical Service Manager, Steris Corporation
De-Masking of Endotoxin in Common Formulations of Biopharmaceuticals
Johannes Reich, PhD Student (MSC), University Regensburg
Efficient Mycoplasma Concentration Technique for Increasing Real-time PCR Sensitivity in Large Sample Volumes
Alexandra Scholz, PhD, Scientist, R&D Microbiology, Sartorius Stedim Biotech
Examination of Factors for Improved Sample Collection for Environmental Surface Monitoring
Kathleen Souza, Senior Research Scientist, EMD Millipore
Choose from 2 Concurrent Sessions
Case Study – Evaluation of Medical Device Challenged with a Biofilm Bioburden
Laura Wahlen, Research Associate, Baxter Healthcare Corporation
10:00 a.m. - 12:00 p.m.
| Salon D
A1: Biofilms and Bioburden Control
Moderator: Kalavati Suvarna, PhD, Senior Microbiologist
Reviewer, CDER, FDA
This session will present practical approaches to the
prevention, detection, and remediation of microbial
contaminations that attendees can use in daily production and
laboratory operations.
This session will also provide a series of case studies that will
take the attendees through the situations and investigations to
the root cause and lessons learned, providing insight to
processes and practices used for bioburden issue resolution.
10:00 a.m. - 12:00 p.m.
| Salon A - C
B1: Parametric Release
Moderator: Kim Sobien, Regulatory Compliance Lead, BD Rx,
Inc.
Parametric release is a sterility release program that is
founded upon effective control, monitoring and documentation
of a validated sterile product manufacturing process where
sterile product release is based upon demonstrated
achievement of critical parameters in lieu of end product
sterility testing (PDA TR No. 30-2012). Through a series of
case studies, this session will provide attendees with industry
and regulatory viewpoints of parametric release.
10:00 a.m. - 10:30 a.m.
Bioburden Control in Biologics Processing - Case Studies
Chris Knutsen, PhD, Associate Director, Microbiology, ABD,
Bristol-Myers Squibb Company
10:00 a.m. - 10:30 a.m.
Industry Experience and Advice for Tomorrow
Michael Sadowski, Director, Sterile Manufacture Support,
Baxter Healthcare Corporation
10:30 a.m. - 11:00 a.m.
Water System Sanitization: Risk-Based Lifecycle Approach
Igor Gorsky, Senior Consultant Engineer, Packaging
Development Laboratory, ConcordiaValSource LLC
10:30 a.m. - 11:00 a.m.
Zen in the Art of Parametric Release: A Regulatory
Perspective
Marla Stevens – Riley, PhD, Team Leader/Senior Review
Microbiologist, CDER, FDA
11:00 a.m. - 11:30 a.m.
Equipment Corrosion and Biofilm Control
Matthew Kennedy, Manager, Process Engineering,
GlaxoSmithKline
Shane Manning, Technology Manager, Biopharm Technology,
GlaxoSmithKline
11:30 a.m. - 12:00 p.m.
Q&A/Discussion
11:00 a.m. - 11:30 a.m.
Microbiological Rapid Release Testing: Bottlenecks
Jeffrey Weber, Senior Scientist, PAT Projects, Pfizer, Inc.
11:30 a.m. - 12:00 p.m.
Q&A/Discussion
12:00 p.m. - 1:15 p.m.
| White Oak/Brookside A/B
Exhibitor Roundtable Luncheon - Exhibitors will be seated at designated tables and will be available for informal discussion with
attendees
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Choose from 2 Concurrent Sessions
1:15 p.m. - 3:15 p.m.
| Salon D
A2: Developing Sterilization Technologies
Moderator: Edward Tidswell, PhD, Director, Sterility
Assurance, Baxter Healthcare Corporation
The use of new technologies for sterilization continues to evolve
as product and packaging characteristics change. This session
will look at several new approaches to sterilization and how
they can be applied to commercial manufacturing.
1:15 p.m. - 1:45 p.m.
Electron Beam: New Potential for Healthcare Products
John Logar, Director, Radiation Sterilization, Johnson &
Johnson
1:45 p.m. - 2:15 p.m.
Gama Sterilization of Biomaterials and Pharmaceuticals
Fatima Hasanain, Polymer Materials Specialist, Nordion, Inc
2:15 p.m. - 2:45 p.m.
Electron Microscopic Imaging in the Support of
Investigations
Jason Mantei, PhD Research Scientist I, Baxter Healthcare
Corporation
2:45 p.m. - 3:15 p.m.
Q&A/Discussion
1:15 p.m. - 3:15 p.m.
| Salon A –C
B2: Objectionable Microorganisms in Non-Sterile
Pharmaceutical Drugs
Moderator: Julie Barlasov, Laboratory Manager, Perritt
Laboratories, Inc.
Some of the recalls or extensive investigations of non-sterile
products happen when objectionable organism is recovered.
Determination of what objectionable organism is and what is
the best methodology to use in order to ensure that the
product/material is free of objectionable organisms (as
required in CFR) is not clearly written in compendia or the CFR.
This session will cover current trends of organisms that are or
can be considered objectionable, methodologies that can be
utilized to assure that objectionable organisms are excluded
from product/material and effective ways to release
product/material for use.
1:15 p.m. - 1:45 p.m.
Objectionable Organism Citations within the NonSterile/Sterile Pharmaceutical Industry
Barry Friedman, PhD, Consultant, Friedman Consultant, LLC.
1:45 p.m. - 2:15 p.m.
Technical Report No. 67 (TR67): Exclusion of Objectionable
Microorganisms from Non-sterile Pharmaceuticals, Medical
Devices and Cosmetics
Anil Sawant, PhD, Vice President, Enterprise Regulatory
Compliance, Johnson & Johnson
2:15 p.m. - 2:45 p.m.
An Approach to Microbiological Testing of Raw Materials
Utilizing Microbial Growth Potential Assessment
Thuy Bui, QC Microbiology Manager, Pfizer, Inc.
2:45 p.m. - 3:15 p.m.
Q&A/Discussion
3:15 p.m. - 4:00 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall
| Salon E - H
4:00 p.m. - 5:30 p.m.
| Salon D
P2: Urban Myths
Moderator: Richard V. Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA
There has been an ever increasing emphasis on "science-based regulation" which begs the question of how much of our common
microbiological wisdom in the pharmaceutical industry is actually based on fact. This session will look at two important aspects of
pharmaceutical microbiology from this perspective. The presenters will explore our current understanding and "best practice"
with an eye to determine whether what we believe is reality is in fact rooted in "good science".
4:00 p.m. - 4:30 p.m.
Urban Myths about Media Fills
Dona Reber, Global Quality Operations, Microbiology and Aseptic Support, Pfizer, Inc.
4:30 p.m. - 5:00 p.m.
Urban Myths and Pharmaceutical Products: A CDER Microbiology Regulatory Perspective
John Metcalfe, PhD, Senior Microbiology Reviewer, CDER, FDA
5:00 p.m. - 5:30 p.m.
Q&A/Discussion
5:30 p.m. - 6:45 p.m.
| Salon E - H
Networking Reception and Poster Presentations in Exhibit Hall -Sponsored in part by Charles River Laboratories
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Tuesday, October 21, 2014
7:00 a.m. - 5:15 p.m.
Registration Open
| Foyer C Alcove
7:00 a.m. - 8:15 a.m.
Continental Breakfast
| Foyer E - H
8:15 a.m. - 9:15 a.m.
| Salon D
P3: Day 2 Keynote Address
Moderator: Kalavati Suvarna, PhD, Senior Microbiologist Reviewer, CDER, FDA
The innovative, breakthrough development of the LAL reagent in 1964 has led to the three principle methods of LAL testing that
are in use today: Gel-Clot, Turbidimetric, and Chromogenic. Based on the physiological reactions of a biological entity Limulus polyphemus - to the presence of endotoxin, the LAL test is an excellent example of how basic research can have a
significant impact. This session will review the fundamentals of the test that transformed our industry, examine new, novel
approaches to endotoxin research, testing and knowledge and discuss current trends, issues and hot topics related to endotoxin
and LAL testing.
8:15 a.m. - 9:00 a.m.
The Original Description of the Limulus Amebocyte Lysate (LAL) Test: From Past to Present
Jack Levin, MD, Professor of Laboratory Medicine, University of California School of Medicine, San Francisco
9:00 a.m. - 9:15 a.m.
Q&A/Discussion
9:00 a.m. - 3:45 p.m.
Exhibit Hall Open
| Salon E - H
9:15 a.m. - 10:00 a.m.
Refreshment Break Poster Presentations and Passport Raffle Prize Drawing in Exhibit Hall
| Salon E - H
POSTER PRESENTATIONS
The following posters will be presented today during the refreshment breaks
Fast and Efficient Co-Detection of Viruses and Mycoplasma in Mammalian Cell Cultures
Vincent Beguin, Compliance Specialist, Merck Millipore
Easy Challenge Tests Inoculations with Ready-to-Use Strains
Sylvanie Cassard, PhD, Corporate Marketing Manager, bioMerieux
Risk Based Approach to Manage Biologic Products Exhibiting Low Endotoxin Recovery (LER)
Joseph Chen, PhD, Head of Global QC Microbiology, Genentech, Inc.
An Assessment for Implementation of the Endosafe Nexus Robotic Endotoxin Testing System
Michael Estepp, Principal Analyst, Genzyme – A Sanofi Company
Development of a Rapid Method for Detection of Mycoplasma by Real-Time PCR
Erica Falls, Senior Scientist, Merck and Company
Evaluation of the Effect of the Volume Through Put and Maximum Flux of Low Surface Tension Fluids on Bacterial
Penetration of 0.2 µM Rated Filters
Martha Folmsbee, PhD, Principal Scientist, Pall Corporation
Ozonated Water-Sterilization, Biofilm Removal, Pyrogen Free Water
Brian Hubka, Principal, PureQuest USA Inc.
Development of qPCR Method for Leptonema Illini as Quantitation for Leptospira Membrane Retention
Corinne Miller, PhD, R&D Manager, Virology & Microbiological Sciences, Process Solutions, EMD Millipore Corporation
Rapid Detection of Yeast in Guar Gum using Flow Cytometry in Conjunction with Selective Enrichment Media
Vikram Patel, Staff Scientist, Becton Dickinson Diagnostics
Environmental Monitoring – Trending Analysis Tool “The 9 Boxes”
Benoit Ramond, PhD, Microbiologist Expert, Sanofi
Effect of MALDI-TOF Library Development on the Efficiency of Operations and Trending and Tracking Capability
Christine Farrance, PhD, Director, R&D, Charles River Laboratories
Alternative Growth Media for the Sterility Test
Kate Shara, PhD, Scientist II, Rapid Micro Biosystems
Sommer Vogel, Research Associate, Rapid Micro Biosystems
Real-time Bacterial Detection for Water Monitoring
Rita Hoke, RPh, Senior Vice President, Commercial Operations, Instant BioScan
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Choose from 2 Concurrent Sessions
10:00 a.m. - 12:00 p.m.
| Salon D
A3: Endotoxin Testing
Moderator: Cheryl Platco, Principal Scientist, Merck Research
Laboratories
Low Endotoxin Recovery has been a concern for the past few
years in response to the June 2012 “Guidance for Industry:
Pyrogens and Endotoxin Questions and Answer”, response #3
concerning the stability of measurable endotoxin in product.
Biological matrices as well as certain placebo matrices have
demonstrated an inability to recover endotoxins when spiked
directly into these products. This session will present important
background information about how an endotoxin molecule
exhibits pyrogenic effects, the differences between native and
purified lipopolysaccharide, and how experimental design can
influence the outcome of the studies. There is valuable new
data to present. This session will provide education and
guidance to anyone testing biological and small molecule
products for endotoxin. A representative of the FDA will also
offer comment.
10:00 a.m. - 10:30 a.m.
Endotoxin Potency Change in the LAL Reactivity and its
Relationship with Pyrogenicity
Masakazu Tsuchiya, PhD, Senior Research Scientist,
Endotoxin and Microbial Detection, Charles River Laboratories
10:30 a.m. - 11:00 a.m.
A Comparative In-vitro and In-vivo Low Endotoxin
Recovery (LER) Recovery
John Dubczak, General Manager, Endotoxin and Microbial
Detection, Charles River Laboratories
10:00 a.m. - 12:00 p.m.
| Salon A - C
B3: Micro Data Deviations Sterile and Non-Sterile
Moderator: Marsha Hardiman, Senior Consultant,
ConcordiaValSource LLC
Microbial contamination investigations are of critical
importance in our industry when recovery of microorganisms
occurs in test samples. Performing thorough, accurate and
timely investigations is key to success in determination of root
cause. Investigations are needed for all microbial data
deviations including environmental monitoring and utility data
excursions; raw material, in-process and product aberrant test
results; and media fill and sterility test positive results. An
update from the PDA Task Force working on the Technical
Report for Microbial Data Deviations will be presented. In
addition, determining sound assignable causes for sterility test
failures will be discussed along with a regulatory perspective
on failure investigations and industry trends.
10:00 a.m. - 10:30 a.m.
Microbial Data Deviations Investigations: Overview of New
PDA Technical Report
Edward Balkovic, PhD, Principal Microbiologist,
Contamination Control, Genzyme – A Sanofi Company
10:30 a.m. - 11:00 a.m.
Sterility Test Failure Investigations
Kenneth Muhvich, PhD, Principal Consultant, Micro-Reliance,
LLC
11:00 a.m. - 11:30 a.m.
Endotoxin Challenges – A Regulatory Perspective
Patricia Hughes, PhD, Lead Consumer Safety Officer, CDER,
FDA
11:00 a.m. - 11:30 a.m.
Microbiological Data Deviations for Sterile and Non-Sterile
Products
David Hussong, PhD, Associate Director, New Drug
Microbiology, CDER, FDA
11:30 a.m. - 12:00 p.m.
Q&A/Discussion
11:30 a.m. - 12:00 p.m.
Q&A/Discussion
Choose from 2 Concurrent Sessions
12:00 p.m. - 1:15 p.m.
Networking Luncheon
| White Oak/ Brookside A/B
1:15 p.m. - 3:15 p.m.
| Salon D
A4: Innovative Technologies: Microbiology Testing
Technologies
Moderator: Edward Balkovic, PhD, Principal Microbiologist,
Contamination Control, Genzyme – A Sanofi Company
“The art challenges the technology and the technology inspires
the art. “ (John Lasseter). In contrast to traditional
microbiological tools, new microbiological technologies are
diverse, commercially expedient and measure microorganisms
in means truly beneficial to assuring product
quality. Traditional microbiological methods suffer from
several well-identified issues, especially long lead time to
results; therefore Rapid Microbiological Methods represent a
means to assure a higher level of quality, and improve the
efficiency of manufacturing operations. This session examines
representative technologies and methodologies; the presenters
will also discuss the challenges.
1:15 p.m. - 1:45 p.m.
Application of Non-invasive Head Space Analysis to Media
Fill Inspection
Tony Cundell, PhD, Consulting Microbiologist
1:45 p.m. - 2:15 p.m.
Rapid Detection and Quantification of Microbial
Contaminants in Process Water by Flow Cytometry
Yongqiang Zhang, PhD, Senior Scientist, Becton Dickinson
Diagnostic
-5–
1:15 p.m. - 3:15 p.m.
B4: Risk Assessments
| Salon A - C
Moderator: Amy McDaniel, PhD, Director, Technical
Operations, Pfizer, Inc.
This session will provide case studies on practical and novel
approaches for applying risk assessments. This session will
explore QRM, Real Time Risk Assessments, as well as Risk
Based EM.
1:15 p.m. - 1:45 p.m.
Risk Based Environmental Monitoring
Marsha Hardiman, Senior Consultant, ConcordiaValSource LLC
1:45 p.m. - 2:15 p.m.
Real Time Risk Assessment of the Cleanroom Environment:
Using QbD Principles to Implement a Proactive Control
Strategy
Sean Toler, Research Scientist III, Baxter Healthcare
Corporation
Session A4 Continued
Session B4 Continued
2:15 p.m. - 2:45 p.m.
Practical Application of Rapid Microbiological Methods to
the USP <1116> Contamination Recovery Rate Approach
Peter Noverini, Senior Field Applications Scientist, Azbil North
America- BioVigilant, Inc.
2:15 p.m. - 2:45 p.m.
Profound Risk Assessment Using Hazard Analysis and
Critical Control Point to Control Biologic Contamination
During Manufacturing of Biologic Products.
Ruth Daniels, PhD, Head, Microbiology Operational
Technical Support and Manufacturing Science Group,
Genzyme – A Sanofi Company
2:45 p.m. - 3:15 p.m.
Q&A/Discussion
2:45 p.m. - 3:15 p.m.
Q&A/Discussion
3:15 p.m. - 3:45 p.m.
Refreshment Break, Poster Presentations and Passport Raffle Prize Drawing in Exhibit Hall
| Salon E - H
3:45 p.m. - 5:15 p.m.
| Salon D
P4: Emerging Leaders
Moderator: Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.
This session is mainly designed to explore the new generation of microbiologist and to give them the opportunity to share their
ideas and views on the most current topics and challenges that faces all microbiologists in general. The goal is to hear new
voices with new faces discussing the daily problems that exist in the day-to-day activities within any Microbiology lab. A select
group of junior managers from across the industry, with hands-on experience, will have the chance to present their current issues
and challenges and the way they were able to resolve them. Also, they will be able to raise their questions and concerns to all
attendees.
3:45 p.m. - 4:00 p.m.
Identifying the Rocks, Pebbles and Stones in your Microbiology Laboratory
Leslie Falco, Quality Scientist II, Pfizer Biotech
4:00 p.m. - 4:15 p.m.
Behind the Curtain: Planning A Secret Isolator EM Program
Shannon Vick, QC Microbiologist, BD Rx Inc.
4:15 p.m. - 4:30 p.m.
Bugs on the Fast Track: Rapid/Automated Microbiology on the Manufacturing Floor
Lindsey Colvin, Manufacturing Scientist, Pfizer Specialty Biotech
4:30 p.m. - 4:45 p.m.
Question Everything – Building an Environmental Monitoring Program on a Firm Foundation
Jonathan Stewart, QC Microbiology Manager, Baxter Healthcare Corporation
4:45 p.m. - 5:15 p.m.
Q&A/Discussion
Wednesday, October 22, 2014
7:00 a.m. - 12:30 p.m.
Registration Open
| Foyer C Alcove
7:00 a.m. - 8:15 a.m.
Continental Breakfast
| Ballroom Foyer C - D
7:00 a.m. - 8:00 a.m.
| Linden Oak
Sterile Processing Interest Group Session
Interest Group Leader: Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation
The manufacture of sterile products continues to receive a great deal of attention during regulatory inspections. This Interest
Group session will review some of the most important points to consider in preparing for regulatory inspections, and provide an
overview of a general inspection plan. Input from the attendees is encouraged and welcomed.
-6–
8:15 a.m. - 9:30 a.m.
| Salon D
P5: USP Updates
Moderator: Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention
Compatible with its overall mission, the role of USP in Microbiology is to develop public standards pertaining to microbiology
that, along with other requirements, ensure the consistent quality of products. This session will provide an overview on current
activities of the USP General Chapters-Microbiology Expert Committee relative to revisions to existing chapters and new chapter
proposals.
8:15 a.m. - 8:40 a.m.
Current Status of <1229> Sterilization and <1228> Depyrogenation – Series of Chapters
Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention
8:40 a.m. - 9:05 a.m.
Revisions Proposed to USP <1223> Validation of Alternative Microbiological Methods
James E. Akers, PhD, Chair, USP General Chapters-Microbiology Expert Committee
9:05 a.m. - 9:30 a.m.
Q&A/Discussion
9:35 a.m. - 10:20 a.m.
| Salon D
P6: Day 3 Keynote Address - Regulatory Updates
Moderator: John Metcalfe, PhD, Senior Microbiology Reviewer, CDER, FDA
This address will highlight the recent experiences from the complementary perspective of an FDA Inspector to provide valuable
insight into the regulatory expectations for the development, validation and ongoing control of sterile product manufacturing
processes.
9:35 a.m. - 10:05 a.m.
Microbiology Inspections – A Regulatory Update
CAPT Sharon Thoma, PharmD, National Expert, Pharmaceutical Inspections, ORA, FDA
10:05 a.m. - 10:20 a.m.
Q&A/Discussion
10:20 a.m. - 10:45 a.m.
Refreshment Break
| Foyer C - D
10:45 a.m. - 12:15 p.m.
| Salon D
P7: Ask the Regulators Panel Discussion
Moderator: Marla Stevens – Riley, PhD, Team Leader/Senior Review Microbiologist, CDER, FDA
Participants will obtain information from a regulatory perspective about common microbiological challenges encountered in the
manufacturing of drug products. Representatives from the FDA will participate in the panel discussion. This session will be
structured in question and answer format.
Panelists
Patricia Hughes, PhD, Lead Consumer Safety Officer, CDER, FDA
David Hussong, PhD, Associate Director, New Drug Microbiology, CDER, FDA
Lori Peters, Consumer Safety Officer, CBER, FDA
CAPT Sharon Thoma, PharmD, National Expert, Pharmaceutical Inspections, ORA, FDA
12:15 p.m.
| Salon D
Closing Remarks
Kalavati Suvarna, PhD, Senior Microbiologist Reviewer, CDER, FDA and Co-Chair, 9th Annual Global Conference on
Pharmaceutical Microbiology Program Planning Committee
-7–
PDA 9th Annual Global Conference on Pharmaceutical Microbiology
October 20-22, 2014 | Bethesda North Marriott | Bethesda, MD
Floor Plan
A-C
Concurrent Sessions
E-H
Plenary Session/
Concurrent session
Exhibit Hall/
Poster Presentations
PDA Registration
Interest
Group
Session
Lunch Overflow/
Networking Luncheon
Exhibitor Roundtable Luncheon/
Networking Luncheon
-8–