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14th PDA Pharmaceutical Microbiology

14th Annual PDA Global Conference on Pharmaceutical Microbiology

Oct 21 - Oct 23, 2019
Rockville, MD

Magnifying the S.C.O.P.E. of Pharmaceutical Microbiology: Science, Compliance, Opportunity, Products, and Engagement

  • Conference
  • The Americas
Program Highlights

Listen to Keynote Speaker, Dr. Steffanie Strathdee, an infectious disease epidemiologist and author of the book, The Perfect Predator: A Scientist’s Race to Save Her Husband from A Deadly Superbug, discuss her quest to save her husband after he contracted a lethal, antibiotic-resistant superbug, how science can overcome the threat of antibiotic resistance, and how important it is for pharma manufacturing professionals to understand the threat of dangerous microbes.

Overview

The 14th Annual PDA Global Conference on Pharmaceutical Microbiology continues the ongoing tradition of addressing the opportunities and challenges most relevant to the future of microbiology in today’s global market. Join new and seasoned professionals from all facets of the field, including global industry, academia, and regulatory authorities, to share insights on how to best prepare for the future through the sharing of best practices, development of standards, and integration of innovative technologies.

Take a look at the many opportunities that will shape the future of the pharmaceutical industry, such as how to best use non-compendial methods for microbial testing of new products, how to overcome challenges with aseptic processing, and what might be in store for the effective use of risk assessment and mitigation in product manufacturing, environmental monitoring, and microbial control. Additionally, the science of biotech microbiology and its impact on the industry in a dynamic fast paced global manufacturing environment will be addressed throughout the Conference.

The comprehensive program agenda will include presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. The Conference will also highlight the following hot topics:

  • Novel biotechnology processes, including cell and gene therapies
  • Globalization of aseptic processing
  • Common microbial deficiencies in regulatory filings and inspections
  • Contamination control case studies
  • Innovative technologies, products, and processes

There will be plenty of opportunities to listen to and directly interact with all the speakers, in addition to lively Q&A sessions that promise to stimulate the discussions and encourage attendee participation. Interactive breakfast sessions will feature small group discussions on topics important to the industry.

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

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Sunday, October 20

    3:00 p.m. – 7:00 p.m.
    Registration Open

  • Monday, October 21

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

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

    8:00 a.m. – 9:45 a.m.
    P1: When the SCOPE Gets Personal: Combining the Roles of Scientist and Caregiver
    Moderator: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence, Bristol-Myers Squibb

    To kick off the Conference, our first plenary speaker has had the unique perspective of experiencing all five of our topic areas of SCOPE in a very personal way. She has explored and developed the Science, followed the aspects of Compliance, sought out and in some cases created her own Opportunities, produced a specific Product, and Engaged with other scientists, doctors, and regulators in order to save a very special patient, her own husband. This incredible story will set the stage for our Conference and leave our audience of microbiologists inspired to continue their focus on innovating, producing, controlling, and releasing life-saving medicines for patients everywhere.

    8:00 a.m. – 8:15 a.m.
    Welcome and Opening Remarks from Conference Co-Chair
    Amy L. McDaniel, PhD, 
    Director, Microbial Center of Excellence, Bristol-Myers Squibb

    8:15 a.m. – 9:15 a.m.
    The Perfect Predator: A Scientist’s Race to Save Her Husband from a Deadly Superbug
    Steffanie A. Strathdee, MSc, PhD, Harold Simon Professor and Co-Director, IPATH, UC San Diegoand Author, The Perfect Predator

    9:15 a.m. – 9:45 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 10:15 a.m. 
    Refreshment Break

    10:15 a.m. – 11:45 a.m. 
    Concurrent Sessions 

    SCIENCE

    A1: Evolving the SCOPE
    Moderator: MaryEllenE. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

    As patient, new product technologies and regulatory expectations evolve we are called upon to explore Science, Compliance, Opportunities, Products, and Engagement in innovative ways in order to demonstrate microbial control. In the cell therapy arena, the use of cell culture media, offers both challenges as well as opportunities regarding a contamination control program. This session will explore the use of cell culture media used in daily manufacturing activities as a potential tool to predict or detect in-process contamination. Additionally, as we strive for increased implementation of Rapid Microbiological Methods throughout the industry, using practical approaches in study design is beneficial. This session will discuss a Most Probable Number (MPN) statistical methodology, using quantitative data from a qualitative test in the implementation of rapid sterility testing.Let’s use sound science to expand our testing capabilities in order to better serve our patients!

    10:15 a.m. – 10:45 a.m.
    Use of Cell Culture Media Microbial Growth Capability as a Potential Tool for the Early Detection of In-Process Contamination
    Rebecca D. Jordan,QC Microbiology Specialist, Celgene, Biotechnology Company

    10:45 a.m. – 11:15 a.m.
    Demonstrating Comparability of Rapid Microbiological Methods: A Practical Approach Using Most Probable Number
    Stacey N. Ramsey, MS, SM(NRCM), Senior Scientist, Microbiology, Alcami Corporation

    11:15 a.m. – 11:45 a.m.
    Questions and Answers/Discussion

    SCIENCE

    B1: Solving Endotoxin Challenges - From Assay to Process Control Strategies
    Moderator: Ed C. Tidswell, PhD, BSc, Executive Director QA, Merck & Co., Inc.

    Drug products administered intravenously, intrathecally, or intravitreally must all meet compendial requirements for bacterial endotoxin (BET). The diversity and complexity of current (and future) product formulations and manufacturing processes represent new and evolving challenges in BET assay methodology and manufacturing process controls. This session is purposed to provide expert guidance in this field supported by real-life case studies.

    10:15 a.m. – 10:45 a.m.
    Endotoxin OOS: Investigating the Root Cause
    Crystal M. Booth, MM, Regional Manager, PSC Biotech

    10:45 a.m. – 11:15 a.m.
    An Endotoxin Control Strategy for the Purification of Antisense Oligonucleotides (ASOs)
    Hien T. Nguyen, MS
    Senior Associate Scientist, Biogen

    11:15 a.m. – 11:45 a.m.
    Questions and Answers/Discussion

    11:45 a.m. – 1:30 p.m. 
    Grand Opening of Exhibit Hall | Networking Lunch | Poster Presentations | Tech Talks

    Poster Presentations

    The following posters will be presented during Monday's refreshment breaks.

    1. A Rapid Alternative to Culture-Based Mycoplasma Detection
      Darren J. Bauer, Product Manager, Thermo Fisher Scientific
    2. Maintaining a Robust Environmental Monitoring Program Through HACCP Living Risk Assessments
      Alana B. Nelson, MS, Scientist, Senior Contamination Control, Genzyme - Sanofi
    3. Monocyte Activation Test: Solution to Testing Medical Products and Protecting Patient Safety
      Shabnam Solati, MS, CEO, CTL-MAT
    4. Can Image Analysis be applied to Environmental Monitoring Samples Workflow? A Proof of Concept Study
      Alberto Poli, Quality Assurance & Regulatory Affairs Manager, Newlab Engineering SR
    5. Impact of Optimizing Processing Variables on the Performance of Lyophilized Prepared Microorganisms
      Megan K. Cox, MS, Research and Development Associate, Microbiologics, Inc.
    6. Simulation of Factor C Activation by Lipopolysaccharide
      Masakazu Tsuchiya, PhD, Senior Research Scientist, Charles River Laboratories
    7. Mold Contamination Challenges
      Ziva Abraham, PhD, CEO, Microrite, Inc.
    8. Best Practices and Innovative Technology Leading the Way to Lean Labs
      David E. Wadsworth, Global Product Manager, Bio-Detection, Suez WTS Analytical Instruments, Inc.
    9. Accurate Identification of Environmental Bacteria by MALDI-TOF Mass Spectrometry using the VITEK® MS Platform
      Félix A. MONTERO JULIANPhD, Scientific Director, bioMerieux
    10. Capsule contamination analysis using Rapid, Automated Microbiology Detection System
      Courtney M. RussellApplications Microbiologist, Rapid Micro Biosystems
    11. Utilizing an Organized Data Driven Approach to Investigate, Solve Problems, and Demonstrate Process Control
      Matthew P. Paquette, MBA, Operational Excellence Manager, Microbial Solutions / Charles River Laboratories
    12. Neutralization Efficacy of Culture Media for Surface Monitoring
      Tim A. Cser,BS, Senior Technology Specialist, MilliporeSigma
    13. Practical Applications of Data Integrity and Audit Trail Review
      Robert A. Lutskus, Associate Director Commercial Operations, Lonza Informatics
    14. Evaluation of the Scanstation 100 System for the Automated Incubation and Analysis of Pharmaceutical Environmental Monitoring Samples Using Standard Petri Plates
      Diarmaid O'Riordan, BSc,QC Microbiology Analyst, Pfizer

    1:30 p.m. – 3:30 p.m.
    Concurrent Sessions

    COMPLIANCE

    A2: Microbial Control Challenges
    Moderator: Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

    Aseptic compliance is an ever-changing target that must be continuously reviewed and improved to maintain patient safety and regulatory compliance. In this session, we will discuss developments, challenges, and expectations of Barrier separation technology for Glove Management Strategy, Visual Airflow (smoke) Studies, and GMP Regulatory Inspector Expectations. These discussions will include examples and case studies from real situations. Come and engage in this exciting dialogue.

    1:30 p.m. – 2:00 p.m.
    GMP Expectations for Sterile Products
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S.FDA

    2:00 p.m. – 2:30 p.m.
    Glove Management Control Strategy Case Study for Aseptic Processing Using Isolator Technology
    Manshi V. Patel, Associate Director, Merck & Co., Inc.

    2:30 p.m. – 3:00 p.m.
    Characterization of Airflow Patterns, Identification of Barrier System Design Flaws, and Cleanroom/Barrier System Integration Mistakes
    Morgan Polen, Contamination Control Expert, Microrite, Inc.

    3:00 p.m. – 3:30 p.m.
    Questions and Answers/Discussion

    OPPORTUNITIES

    B2: Sterility Assurance of Cell-Based and Genomic Therapies
    Moderator: Renée S. Blosser, MS,Microbiogist, CVM,FDA

    Sterility testing of cell-based and genomic therapies presents unique challenges due to the presence of cells, stability constraints, and small batch size. The development of novel rapid methods and evaluating existing methods provide an opportunity for improved in vitro testing of these therapies to ensure sterility and patient safety while considering the unique profiles of these products. This session will discuss sterility test methods from an industry and regulatory perspective.

    1:30 p.m. – 2:00 p.m.
    Comparative Performance Evaluation of USP, BacT/ALERT Dual-T, and Bactec FX for Contaminant Detection in Cell Products, Viral Vectors, and Radiolabeled PET-Drugs
    James ET Gebo, MPA, Quality Assurance Manager, National Institutes of Health, Department of Laboratory Medicine, Sterility Testing Service

    2:00 p.m. – 2:30 p.m.
    Case Study on the Selection and Validation of a Rapid Sterility Test for a Novel Cell Therapy Oncology Product
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    2:30 p.m. – 3:00 p.m.
    Randa Melhem, PhD, Consumer Safety Officer, CBER, U.S.FDA

    3:00 p.m. – 3:30 p.m.
    Questions and Answers/Discussion

    3:30 p.m. – 4:15 p.m. 
    Refreshment Break | Poster Presentations
    Sponsored by Boston Analytical

    4:15 p.m. – 5:45 p.m.
    Concurrent Sessions

    PRODUCTS

    A3: Keeping Products Safe for Our Patients
    Moderator: Christine Sherman, BA, Global Microbiology, Takeda

    Providing innovative and safe products is the focus of our industry all around the world. This session will provide that perspective of sterility assurance from two different regulatory bodies, Health Canada and the U.S. FDA. Representatives from Health Canada will discuss a case study for sterility and endotoxin issues for a natural, sterile product used in wound cleaning. Additionally, the session will provide the U.S. FDA view on one of the most critical activities that support sterile products, the media fill.

    4:15 p.m. – 4:45 p.m.
    Sterile Natural Health Products for Wound-Cleaning Failed Sterility and Endotoxin Testing
    Karine Lebel, MSc, 
    Microbiologist, Health Canada
    Geneviève Dufour, 
    Microbiologist, Health Canada

    4:45 p.m. – 5:15 p.m.
    Media Fills: FDA Regulatory Perspective on Aseptic Processing
    Virginia A. Carroll, PhD, Microbiologist, CDER, U.S. FDA

    5:15 p.m. – 5:45 p.m.
    Questions and Answers/Discussion

    ENGAGEMENT

    B3: Symbiotic Connections
    Moderator: Irving Ford, MSc,Head, CAR T QC Laboratories,Celgene, Biotechnology Company

    Whether partnering with a regulatory body for a new product, existing product, or just to ask a question or interviewing or collaborating with personnel in your respective organization to complete an investigation, engagement is a key aspect in ensuring success. In this session, we will hear from U.S. FDA and industry on how engagement is key to ensuring successful outcomes in establishing/maintaining mutual reliance between industry and regulators as well as in ensuring the involvement of appropriate personnel and data collection to complete a thorough scientifically based investigation.

    4:15 p.m. – 4:45 p.m.
    Overview of the U.S.-E.U. Mutual Recognition Agreement
    Helen Y. Saccone, PharmD, MSEL,Senior Advisor, CDER,U.S.FDA

    4:45 p.m. – 5:15 p.m.
    Key Regulatory and Compendia Elements on How to Investigate a Sterility Test Microbiological Data Deviation: Frantic, Facts, and Fiction
    Dennis E. Guilfoyle, MS, PhD,Senior Director, Microbiology Regulatory Compliance,Johnson & Johnson

    5:15 p.m. – 5:45 p.m.
    Questions and Answers/Discussion

      

    5:45 p.m. – 7:00 p.m. 
    Networking Reception | Poster Presentations



  • Tuesday, October 22

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

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m.
    Breakfast Roundtable: Microbiology/Environmental Monitoring Interest Group and Upcoming Tech Report Update
    Moderators: Josh Eaton, Assistant Director, Scientific Affairs, PDA

    Start your day with information on PDA’s current technical report activities and activities within the Microbiology/Envrionmental Monitoring Interest Group. Updates will be provided on PDA’s TR13 revision and new TRs on Low Bioburden EM, Microbiological Deviations, and Contamination Control Strategy. A roundtable discussion following the updates will explore the needs of the Interest Group members and an opportunity to help shape future activities.

    7:15 a.m. – 8:15 a.m
    Roundtable Discussion
    Julie Barlasov-Brown, Associate Director, Sterile and Microbiology QA, Merck & Co., Inc.
    Irving Ford, MSc, Head, CAR T QC Laboratories, Celgene, Biotechnology Company
    Marc Glogovsky, Senior Consultant – Microbiology, Valsource LLC
    Dona B. Reber, MEd, SM(NCRM), Director/Team Leader Microbiology and Aseptic Support, Global Quality Operations, Pfizer

    8:30 a.m. – 10:00 a.m.
    P2: Microbiology in Space: Looking Upward and Beyond!
    Moderator: MaryEllen E. Usarzewicz, MS, Associate Director, ASO Microbiology, Bristol-Myers Squibb

    50 years ago, American astronauts first set foot on the moon. There was a lot of attention toward microbiology at NASA at this time. In some ways, microbiology hasn’t changed much at NASA in these past 50 years, but in other ways huge advances are moving the field forward. In this session, Dr. Sarah Wallace will discuss pre-flight and in-flight microbial monitoring for the International Space Station, including the current requirements and risk posture. Dr. Wallace will provide insight into the Genes in Space-3 investigation aboard the space station. This was the first-time microbes were collected, cultured and identified off the planet. She will then discuss the BEST (Biomolecule Extraction and Sequencing Technology) payload which goes beyond culture and implements a direct swab-to-sequencer method. Highlights will also include a better understanding of the ISS Microbiome, The Molecular Space Age as well as microbial considerations with regard to future NASA programs, including The Gateway and Artemis Programs with Mars on the horizon.

    8:30 a.m. – 9:30 a.m.
    Spaceflight Microbiology: Beyond the Cultures
    Sarah L. Wallace, PhD, Microbiologist, NASA Johnson Space Center

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    10:00 a.m. – 10:45 a.m.
    Refreshment Break | Passport Drawing | Poster Presentations

    Poster Presentations

    The following posters will be presented during Tuesday’s refreshment breaks.
    1. Common Myths in the Pharmaceutical Industry Related to Contamination Control
      Jim N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation
    2. Use of Enumerated Mycoplasma Controls to Assess Media Quality for Growth Promotion Testing
      Karla I. Fjeld, PhD, Research and Development Scientist, Microbiolgics, Inc.
    3. An Innovative Statistical Approach to Validation of Rapid Sterility Testing with the BacT/ALERT Dual-T System
      Dorien Ruegebrink, BSc, Specialist, Merck & Co., Inc.
    4. Endotoxin Detection Using Recombinant Factor C
      Kevin L. Williams, Senior Scientist R&D, bioMerieux
    5. Evaluation and Optimization of MALDI-TOF Mass Spectrometry for Identification of Filamentous Fungi during Environmental Monitoring
      Komal K. Iqbal, Research Assistant I, Charles River Laboratories
    6. Review of Current Worldwide Microbiology Testing Methods and Markets in Pharmaceutical Manufacturing
      Robert Ferguson, MBA, President, Strategic Consulting Inc
    7. Evaluation of TrioBas Mono and Trio for Environmental Monitoring in Sterile Medical Product Manufacturing Clean Rooms
      Roberto I. Ligugnana, President, VILLA CELLA
    8. Species Differentiation of the Bacillus Cereus Group using the pycA Gene Sequence and an Assessment of its Operational Impact for Pharmaceutical Manufacturers
      Joseph S. Danner, R&D Research Assistant II, Charles River Laboratories
    9. Remediation of Low–Level Mold Recoveries in a Media Formulation Room of a Biologics Manufacturing Facility
      Wireko Manu-Tawiah, PhD, Scientist Principal, Contamination Control, Sanofi
    10. The Monocyte Activation Test: Validation and Analysis
      Matthias K. Koch, PhD, Senior Scientist RND, Lonza
    11. Data Integrity in the Microbiology Laboratory 
      Kimi M. Timberlake, MBA, PMCOperations Software Systems Specialist, Charles River Laboratories
    12. Real Time Microbial Detection: True Water System Surveillance for Better Process Control Tool and Risk Reduction
      Arundhati Samanta, MBAGlobal Product Manager, Mettler-Toledo Thornton
    13. Comprehensive Evaluation of Compendial USP, BacT/ALERT Dual-T, and BACTEC FX for the Detection of Product Sterility Testing Contaminants
      Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health
    14. Reducing the Risk of Manual QC Microbiology with a Rapid, Automated Microbiology Detection System
      Kham Nguyen, Rapid Micro Biosystems

    10:45 a.m. – 12:45 p.m.
    Concurrent Sessions 

    PRODUCTS

    A4: From Prototype to Patient: The Science of Product Development
    Moderator: Kim R. Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    The space between the first idea and filing a new product in the healthcare world requires many facets to be considered, including method development, validation, user application, product efficiency, and communication of the new product to regulatory bodies. This dynamic session explores the development of a new technology, a case study on process development, and details about a transparency initiative from the U.S. FDA regarding microbiology product quality topics.

    10:45 a.m. – 11:15 a.m.
    Development and Evaluation of a Fully Automated “Laboratory in a Pouch” Mycoplasma Detection Method that Improves the Ease-of-Use and Time-to-Result
    Kenneth P. Tai, PhD,
    Quality Control Scientist, Genentech
    William E. Barry, PhD, Scientist I, BioFire Defense, LLC

    11:15 a.m. – 11:45 a.m.
    The Effect of Gamma Irradiation Process Interruption on Microbial Resistance of Healthcare Products
    Fatima Hasanain, MA, 
    Polymer Materials Specialist, Nordion, A Sotera Health Company

    11:45 a.m. – 12:15 p.m.
    U.S. FDA Efforts to Improve Transparency in Regulatory Decisions Involving Product Quality Microbiology
    John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, U.S. FDA

    12:15 p.m. – 12:45 p.m.
    Questions and Answers/Discussion

    PRODUCTS

    B4: CAR T Products: Control Strategies and Partnerships
    Moderator: Ebony S. Arrington, MS, Manager, Production Operations, Pfizer

    The newest products designed to save the lives of critically ill patients require unique production and release strategies ensuring speed and efficiency while maintaining strict microbial control. This challenge has expanded the scope of microbiology on many levels, including the area of partnership with regulatory agencies. This session will highlight contamination control and release strategies for CAR T products as well as FDA case studies related to these novel products.

    10:45 a.m. – 11:15 a.m.
    Contamination Control Testing/Release Strategy for CAR T Products
    Irving Ford, MSc, 
    Head, CAR T QC Laboratories, Celgene, Biotechnology Company

    11:15 a.m. – 11:45 a.m.
    Regulatory Representative Invited

    11:45 a.m. – 12:15 p.m.
    Virtual Reality Training for a CAR T Cell Therapy Production Unit
    Timothy P. Kedzior, MED,
    Instructional Design Lead, Novartis Pharmaceuticals Corporation

    12:15 p.m. – 12:45 p.m.
    Questions and Answers/Discussion

    12:45 p.m. – 1:45 p.m.
    Networking Lunch | Poster Presentations | Tech Talks

    1:45 p.m. – 3:45 p.m.
    Concurrent Sessions

    COMPLIANCE

    A5: Container Closure Integrity
    Moderator: Bo Chi, PhD, Microbiologist, CDER, U.S. FDA

    Container closure integrity (CCI) breaches in parenteral drug products may result in loss of sterility and product contamination. Therefore, CCI should be maintained throughout the shelf-life of these products. In this session, we will discuss the different types of CCI tests including recent advances and challenges and regulatory expectations. CCI will be illustrated with case studies and the impact of plunger stopper movement of pre-filled syringes on sterility and CCI will be discussed.

    1:45 p.m. – 2:15 p.m.
    Container Closure Integrity Testing
    Lauren E. Levac, MS, Senior Scientist, PPD

    2:15 p.m. – 2:45 p.m.
    Impact of Container Closure on Drug Safety
    Reyes Candau-Chacon, PhD, Quality Assessment Lead, CDER, U.S. FDA

    2:45 p.m. – 3:15 p.m.
    The Impact of Syringe Plunger Stopper Movement on Container Closure Integrity: Microbial Incursion Test 
    Janet Perez-Brown, Senior Research Scientist I, Bristol-Myers Squibb  

    3:15 p.m. – 3:45 p.m.
    Questions and Answers/Discussion

    OPPORTUNITIES

    B5: Opportunities
    Moderator: Leslie A. Furr, MS, SM (NRCM), Associate Scientific Liaison, US Pharmacopeia

    To ensure product quality and safety, it is essential that manufacturing controls take microbiological concepts into account during equipment selection and facility design. In this session, U.S. FDA and industry experts will discuss the importance of selecting the appropriate equipment and demonstrate performance examples of these devices to minimize contamination risk. This discussion will also review the key areas in developing an appropriate microbial control program.

    1:45 p.m. – 2:15 p.m.
    Considerations in the Selection of Sterile Connection Devices for Patient Safety
    Will Waterfield, PhD, Independent Consultant

    2:15 p.m. – 2:45 p.m.
    How to Audit Sanitary Design of Non-Sterile Product Manufacturing 
    Andrew Dick, MS, Senior Principal QA Microbiologist, Johnson & Johnson  

    2:45 p.m. – 3:15 p.m.
    J. Kevin Rice, PhD, Review Chemist, CVM, U.S. FDA

    3:15 p.m. – 3:45 p.m.
    Questions and Answers/Discussion

    3:45 p.m. – 4:30 p.m.
    Refreshment Break | Passport Drawing | Poster Presentations 

    4:30 p.m. – 6:00 p.m.
    P3: Circle of Leaders: Future Leaders and Experienced Leaders
    Moderator: Irving Ford, MSc, Head, CAR T QC Laboratories, Celgene, Biotechnology Company and Mitch B. Garber, BS, RPh, Director Sterile & Bio Pharm Product Quality, GlaxoSmithKline

    As microorganisms must continually adapt to their environment to survive and proliferate, so must a microbiologist/scientist during his/her career. The science of microbiology continues to evolve which presents many different career opportunities for a microbiologist/scientist. The session will highlight the career journeys of experienced leaders as well as up and coming leaders in the science of microbiology and pharmaceutical industry. Come and engage in this exciting dialogue and you too may be surprised at the many opportunities that exist for your career path.

    4:30 p.m. – 6:00 p.m.
    Experienced Managers
    Joyce Hansen, Vice President, J&J Microbiological Quality & Sterility Assurance, Johnson & Johnson
    Anil Sawant, MSc, PhD, Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

    Future Leaders Who Have Stayed or Become Managers
    Lindsey L. Colvin, Associate Director, Merck & Co., Inc.
    Ayako Hasegawa, PhD, Associate Director, Allergan

    Independent Contributors
    Jay S. Bolden, Senior Consultant Quality-Biologist, Eli Lilly and Company
    Hilary A. Chan, MS, Principal QC Scientist, Takeda


  • Wednesday, October 23

    7:00 a.m. – 12:30 p.m.
    Registration Open

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m.
    Breakfast Roundtable: Ask the Industry
    Moderators: Christine Sherman, BA, Global Microbiology, Takeda and Kim R. Sobien, MBA, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    Bring your coffee and some questions and join us early for a chat with industry experts with a wide variety of expertise! This will be a moderated open forum to ask about pharmaceutical microbiology hot topics such as rapid methods, non-sterile products, biologics, CAR-T, disinfection, contamination control, aseptic practices, and more! Come and hear what’s on the minds of your colleagues and friends! If you’re the shy type, question cards can be found the lobby if you’d like to submit a question in advance.

    7:15 a.m. – 8:15 a.m
    Roundtable Discussion
    Andrew Dick, MS, Senior Principal QA Microbiologist, Johnson & Johnson
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC
    Jim N. Polarine, MA, Senior Technical Service Manager, STERIS Corporation
    Dona B. Reber, MEd, SM(NCRM), Director/Team Leader Microbiology and Aseptic Support, Global Quality Operations, Pfizer
    Marsha Steed, Director Global QC Microbiology and Contamination Control, BlueBird Bio

    8:30 a.m. – 10:00 a.m.
    P4: When the SCOPE Expands: Drawing Conclusions on Microbial Diversity in our Homes and Beyond
    Moderator: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence, Bristol-Myers Squibb

    Working together as a community of microbiologists is critical in advancing the science of microbiology in the pharmaceutical industry.  In a unique application of this philosophy of working together, our final plenary speaker engaged citizen scientists from around the world to efficiently collect samples globally, adding to his understanding of the diversity of microorganisms in our own homes. This presentation has implications to the diversity of microorganisms in our manufacturing facilities around the world, since we bring our flora from our homes into the places in which we work. Understanding the nature and interactions of microorganisms on our bodies and even in areas such as shower heads (with potential applications to safety showers in manufacturing facilities), can lead to better risk assessment and appropriate levels of control in low bioburden and aseptic manufacturing facilities.

    8:30 a.m. – 9:30 a.m.
    Never Home Alone: The History and Future of Our Life Indoors
    Rob Dunn, PhD, Professor, Applied Ecology, NC State University and Author, Never Home Alone

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    10:00 a.m. – 10:30 a.m.
    Refreshment Break

    10:30 a.m. – 12:00 p.m.
    P5: Ask the Regulators Panel Discussion
    Moderator: Yeissa Chabrier-Rosello, PhD, Microbiologist, CDER, U.S. FDA and John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, U.S. FDA

    During this interactive session, U.S. FDA will provide insight into questions posed by audience participants. The session is targeted to participants from all segments of the pharmaceutical industry and will provide valuable perspectives from agency experts on the topics of Science, Compliance, Opportunities, Products and Engagement. U.S. FDA reviewers of sterility assurance, aseptic processing, and terminal sterilization for small molecules, as well as reviewers of biotechnology applications will provide their perspective on audience questions. Expert compliance personnel will provide their perspectives on inspection-related questions. Don’t miss this unique opportunity to interact with regulators in an open forum focused exclusively on your microbiology concerns!

    10:30 a.m. – 12:00 p.m.
    Panel Discussion
    John T. Arigo, PhD, Branch Chief, CDER, U.S. FDA
    Reyes Candau-Chacon, PhD, Quality Assessment Lead, CDER, U.S. FDA
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA
    Anthony F. Lorenzo, Lead Consumer Safety Officer, CBER, U.S. FDA

    12:00 p.m. 
    Closing Remarks from the Conference Co-Chair
    Yeissa Chabrier-Rosello, PhD, 
    Microbiologist, CDER, U.S. FDA



Highlighted Speakers

Rob Dunn
Rob Dunn
NC State University
Steffanie Strathdee
Steffanie Strathdee
UC San Diego
Sarah L. Wallace
Sarah L. Wallace
NASA Johnson Space Center

Additional Information

  • Learning Objectives

    Learning Objectives

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

    • Broaden their knowledge in many areas of Microbiology by listening to the leaders in the industry in such topics as novel processes, products, and technologies
    • Deepen their understanding of topics such as microbial risk, microbial control, and endotoxin testing
    • Identify current and future trends in Microbiology
    • Implement improvements at their own facilities using information gained through expert presentations and networking opportunities
    • Identify local regulatory and pharmacopeial expectations
    • Understand global aspects of microbiology and aseptic processing
    • Summarize best practices for utilizing EM data to control processes
  • Who Should Attend

    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

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

Got a Question? We have answers

Contact Us

Virtual Attendance

Can't make it to Rockville, MD in person?

Virtual attendance allows you to experience, from the comfort of your home or office, all the presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. Interactive features in the live-stream player allow you to enjoy a collaborative experience that connects you with a community of practitioners from around the world.

Participate virtually at a discounted rate of $1,500!

Travel

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 & Conference Center

5701 Marinelli Rd
Rockville, MD
Phone: +1 (301) 822-9200

Bethesda North Marriott Hotel & Conference Center
  • Accommodations

    The PDA room block is currently full, however there may still be rooms available at the prevailing rate. Please contact the hotel directly at +1 (301) 822-9200 to secure your reservations. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6:00 p.m. (EDT) on the date of arrival otherwise specified on your reservation information.

  • Amenities
    The Marriott Bethesda North 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. This hotel has a smoke-free policy and no pets are allowed.

How to Get Here

By Air

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.

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.

By Car

Bethesda North Marriott is located at 5701 Marinelli Road, Rockville, MD 20852.

Hotel Parking
Hotel parking for registered guests: $17 daily
Conference Center day guests: $2.50 hourly, max of $30 per day.

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price by August 9
Conference Conference + Workshop
Member $2,195 $3,540
Non-member $2,474 $4,019
Young Professional Member $1,098
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310

















Regular Registration
Registration Type Price after August 9
Conference Conference + Workshop
Member $2,795 $4,440
Non-member $3,074 $4,919
Young Professional Member $1,398
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Academic Member $700
Academic Non-member* $800
Student $280
Student Non-member* $310

One Day Only Registration
Member $1,318
Non-member $1,430

















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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Sep 22, 2019, no fee will be charged. After Sep 22, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Sep 22, 2019, a full refund will be given minus a $200 fee. After Sep 22, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

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Related Events

Related Events

2019 PDA Rapid Microbiological Methods Workshop

October 23-24 | Rockville, MD

The 2019 PDA Rapid Microbiological Methods Workshop will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes. Presentations by subject matter experts and global regulators will focus on real-world practices for rapid and alternative microbiology testing of in-process samples and sterile and nonsterile finished product.

Learn more

Contact

Program Inquiries
  • Brooke Schneider, CMP
    Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
Exhibition Inquiries
Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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