Global Event Calendar and Registration

PDA 9th Annual Global Conference on Pharmaceutical Microbiology

Lessons from Today and Advice for Tomorrow
Oct 20 - Oct 22, 2014 |
Oct 22, 2014 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Conference
October 20-21
October 23-24
Add event to: ICal Outlook Google Calendar

The 9th Annual Global Conference on Pharmaceutical Microbiology will explore current issues in sterile manufacturing, innovative technologies, parametric release, workforce development, and a variety of other topics that highlight the ever-evolving world of pharmaceutical microbiology.

Program Highlights

Brochure

Download Brochure Brochure Mail Copy Current Agenda

Do you often wonder what challenges other microbiologists in the industry are facing and how are they dealing with them? Are you curious to know the opinions of the regulators regarding current microbiological issues and trends? Are you unable to find answers for many of your pharmaceutical microbiology questions?  Register for the PDA 9th Annual Global Conference on Pharmaceutical Microbiology and gain the answers to these and other questions plaguing the pharmaceutical microbiology industry from key industry leaders.

Jack Levin
Jack Levin, MD

University of California School of Medicine
Inventor of the LAL Test
Sharon Thoma
Sharon Thoma, PharmD

Food and Drug Administration
National Expert in Pharmaceutical Inspections
Jan Vinje
Jan Vinjé, PhD

Center for Disease Control
Technical Expert on Norovirus Outbreaks, Disinfection and Vaccines
Speaker Biographies

PDA's 9th Annual Global Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces on a daily basis. The conference will further explore the skillful navigation of current and future microbiology regulations – using risk based thinking to defend practices and validation as well as smart and sustainable lab practices. The comprehensive program agenda will include presentations from regulatory and industry experts from around the world who will share recent case studies and current trends in the field of pharmaceutical microbiology. The conference will also highlight the following additional current hot topics:

  • Biofilms, Bioburden and Cleaning Validation
  • Sterilization Technologies and Parametric Release
  • Microbiology Data Deviations and Objectionable Microorganisms
  • Endotoxin Testing
  • Risk Assessments
  • Innovative Technologies and Microbiology
  • Myths around Media fills and Regulatory concerns

There will be plenty of opportunities to listen to and directly interact with all of the speakers, in addition to lively Q&A sessions that promise to stimulate the discussions and encourage attendee participation.

During the conference, PDA will host many poster presentations and an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies.

Learning Objectives

At the completion of this conference, participants will be able to:

  • Widen their knowledge in many areas of Microbiology by listening to the leaders in the industry in such topics as managing microbial risk, Microbial contamination and risk management in aseptic processing/manufacturing
  • Identify current trends in Microbiology (New Technologies in both testing and sterilization.)
  • Implement appropriate strategies for maintaining a non-sterile manufacturing environment (the importance of microbial identification, testing for and understanding the impact of objectionable organisms and resolving microbial challenges associated with non-sterile operations)
  • Summarize new advances in rapid microbiological methods, microbial identification technologies, endotoxin testing.
  • Explain the elements of a Microbiology data deviations
  • Identify local regulatory and pharmacopeial expectation

Who Should Attend

Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation
Level of Expertise: Executives, Management, Scientists/Technicians
Job Function: Scientist/Technician, Research, Analyst, Bench personnel

Conference Inquiries

Leon D. Lewis 
Director, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 149 
Email: lewis@pda.org

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition and Sponsorship Inquiries

David Hall
Vice President, Sales 
Tel: +1 (301) 760-7373 
Direct: +1 (240) 688-4405
E-mail: hall@pda.org

Preliminary Program Agenda as of August 28, 2014

Sunday, October 19, 2014

4:00 p.m. - 6:00 p.m.
Registration Open

Monday, October 20, 2014

7:00 a.m. - 5:30 p.m.
Registration Open

7:00 a.m. - 8:00 a.m.
Continental Breakfast

8:00 a.m. - 8:15 a.m.
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.
P1:  Opening Keynote Address: Investigation of Norovirus Outbreak

Moderator: Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.

Session Description: 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

9:15 a.m. - 10:00 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall

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

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

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.
A1:  Biofilms and Bioburden Control

Moderator: Kalavati Suvarna, PhD, Senior Microbiologist, CDER, FDA

10:00 a.m.-12:00 p.m.
B1: Parametric Release

Moderator: Kim Sobien, Regulatory Compliance Lead, BD Rx, Inc.

Session Description:  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. 

Session Description: 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 from both US and EU perspectives 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

10:30 a.m. - 11:00 a.m.
Water System Sanitization: Risk-Based Lifecycle Approach 
Igor Gorsky, Senior Consultant Engineer, Packaging Development Laboratory, ConcordiaValSource LLC

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

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.
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.
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.
Exhibitor Roundtable Luncheon - Exhibitors will be seated at designated tables and will be available for informal discussion with attendees   

1:15 p.m. - 3:15 p.m.
A2: Developing Sterilization Technologies

Moderator: Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation

1:15 p.m. - 3:15 p.m.
B2: Objectionable Microorganisms in Non-Sterile Pharmaceutical Drugs

Moderator: Julie Barlasov, Laboratory Manager, Perritt Laboratories, Inc.

Session Description: 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.

Session Description: 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 recoveries.

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. - 1:45 p.m.
Objectionable Organisms Citations within the Non-Sterile/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

4:00 p.m. - 5:30 p.m.
P2: Urban Myths

Moderator: Richard V. Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA

Session Description: 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.
Development of a Rapid Method for Detection of Mycoplasma by Real-Time PCR
Erica Falls,
Senior Scientist, Merck and Company

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.
Networking Reception and Poster Presentations in Exhibit Hall -Sponsored in part by Charles River Laboratories    

Tuesday, October 21, 2014

7:00 a.m. - 5:15 p.m.
Registration Open

7:00 a.m. - 8:15 a.m.
Continental Breakfast

8:15 a.m. - 9:15 a.m.
P3: Day 2 Keynote Address
Moderator: Kalavati Suvarna, PhD,
Senior Microbiologist Reviewer, CDER, FDA

Session Description: 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

9:15 a.m. - 10:00 a.m.
Refreshment Break Poster Presentations and Passport Raffle Prize Drawing in Exhibit Hall

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


10:00 a.m. - 12:00 p.m.                                  
A3: Endotoxin Testing

Moderator: Cheryl Platco, Principal Scientist, Merck Research Laboratories

10:00 a.m. - 12:00 p.m.                          
B3: Micro Data Deviations Sterile and Non-Sterile

Moderator: Marsha Hardiman, Senior Consultant, ConcordiaValSource LLC

Session Description: 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.

Session Description: 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.
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

11:00 a.m. - 11:30 a.m.
Endotoxin Challenges – A Regulatory Perspective
Patricia Hughes, PhD, Lead Consumer Safety Officer, CDER, FDA

11:30 a.m. - 12:00 p.m.
Q&A /Discussion

10:00 a.m. - 10:30 a.m.
Micro Data Deviations Investigations: Overview of New PDA Technical Report
Edward Balkovic, PhD, Prinicipal 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.
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

12:00 p.m. - 1:15 p.m.
Networking Luncheon

1:15 p.m. - 3:15 p.m.
A4: Innovative Technologies: Microbiology Testing Technologies

Moderator: Edward Balkovic, PhD, Principal Microbiologist, Contamination Control, Genzyme – A Sanofi Company

1:15 p.m. - 3:15 p.m.
B4: Risk Assessments

Moderator: Amy McDaniel, PhD, Director, QC Microbiology, Pfizer, Inc.

Session Description: “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.

Session Description: 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.
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

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.  

2:45 p.m. - 3:15 p.m.
Q&A/Discussion

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

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

3:15 p.m. - 3:45 p.m.
Refreshment Break, Poster Presentations and Passport Raffle Prize Drawing in Exhibit Hall

3:45 p.m. - 5:15 p.m.
P4: Emerging Leaders

Moderator: Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.

Session Description: 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
7:00 a.m. - 8:15 a.m.
Continental Breakfast

7:00 a.m. - 8:00 a.m.
Sterile Processing Interest Group Session
Interest Group Leader
: Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation

Session Description: 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.

8:15 a.m. - 9:30 a.m.
P5 - USP Updates

Moderator: Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention
Session Description:  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> Depryogenation - Series of Chapters
Radhakrishna S. Tirumalai, PhD,
Principal Scientific Liaison,US Pharmacopeial Convention

8:40 a.m. - 9:05 a..m.
Revision Proposted 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.
P6: Day 3 Keynote Address - Regulatory Updates

Moderator: John Metcalfe, PhD, Senior Microbiology Reviewer, CDER, FDA

Session Description: 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

10:45 a.m. - 12:15 p.m.
P7:  Ask the Regulators Panel Discussion

Moderator: Marla Stevens – Riley, PhD, Team Leader/Senior Review Microbiologist, CDER, FDA

Session Description: Participants will obtain information from a regulatory perspective about common microbiological challenges encountered in the manufacturing of drug products. Representatives from the FDA and other regulatory agencies will participate in the panel discussion. This session will be structured in question and answer format.

CBER Representative Invited
Patricia Hughes, 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.
Closing Remarks

Kalavati Suvarna, PhD, Senior Microbiologist, CDER, FDA andCo-Chair, 9th Annual Global Conference on Pharmaceutical Microbiology Program Planning Committee

  Before August 11, 2014 August 11 – September 9, 2014 After September 9, 2014
Member $1,695 $1,895 $2,095
Nonmember $1,944 $2,144 $2,344
Government/Health Authority Member $700 $700 $700
Government/Health Authority Nonmember* $800 $800 $800
Academic Member $700 $700 $700
Academic Nonmember* $800 $800 $800
Student Member $280 $280 $280
Student Nonmember* $310 $310 $310

All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this workshop and course.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by August 21, 2014your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted).

REFUNDS for FULL CONFERNCE/EVENTS: If your written request in received on or before August 21, 2014, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for this event, I authorize PDA the right to record and photograph me to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recording/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

To make a reservation, please contact Melissa Pazornik via phone (301) 656-5900 ext. 221 or email at pazornik@pda.org.
Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Bethesda North Marriott Hotel and Conference Center 
5701 Marinelli Road 
Bethesda, MD 20852
Phone: +1 (301) 822-9200

Overflow Hotels within Driving Distance to Bethesda North Marriott

Please note: PDA is not holding rooms.  All rates and rooms are based on availability.

Rockville Hilton
Address: 1750 Rockville Pike, Rockville, MD 20852
Phone: 301-468-1100
Proximity from Bethesda North Marriott: Driving – 1.22 miles

Bethesda Marriott Suites
Address: 6711 Democracy Boulevard, Bethesda, MD 20817
Phone: 301-897-5600
Proximity from Bethesda North Marriott: Driving – 2.55 miles

Bethesda Marriott
Address: 5151 Pooks Hill Road, Bethesda, MD 20814
Phone: 301-897-9400
Proximity from Bethesda North Marriott: Driving – 2.61 miles

Amenities

The Bethesda North Marriott Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron and an ironing board.

Travel

Area Airports 
Reagan National Airport (DCA) is approximately 20 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International, 24 miles away, and Baltimore-Washington International, 34 miles away.

Ground Transportation 
Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75. 

Driving
Bethesda North Marriott is located on Marinelli Road off of Rockville Pike in Rockville.

Metro
The Bethesda North Marriott is located on the RED line at the White Flint Station.

Hotel Parking
$15 Self Parking

Diamond Sponsors Charles River bioMerieux Platinum Sponsor Associates of Cape Cod EMD Millipore Media Sponsor Drug Development Drug Development Drug Development Drug Development

The PDA 9th Annual Global Conference on Pharmaceutical Microbiology will provide your company an exclusive opportunity to gain access to and network with key decision makers from the pharmaceutical and biotech manufacturing industry. Find new customers and strengthen current relationships by exhibiting at or sponsoring the industry’s leading conference for professionals involved in the field of pharmaceutical microbiology.

Attendees will include industry professionals from microbiology, manufacturing, compliance, quality, research and development, engineering, validation, regulatory affairs as well as executives, managers, scientists, technicians and analysts.

Become a sponsor and/or exhibit at the PDA 9th Annual Global Conference on Pharmaceutical Microbiology and strengthen your brand image, increase your visibility, and gain access to leaders and subject matter experts in the biopharmaceutical industry.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales
Direct: +1 (301) 760-7373 | Cell: +1 (240) 688-4405
Email: hall@pda.org

Closed
Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.