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2021 PDA Pharmaceutical Microbiology Conference

Oct 04 - Oct 06, 2021
Washington, DC

Microbiology is Evolving: Rising to the Challenge

  • Conference
  • The Americas

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Welcome to the 2021 PDA Pharmaceutical Microbiology Conference!

This Conference 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
  • Learned lessons in a post COVID world-perspective from industry and regulators

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.


  • Day 1
  • Day 2
  • Day 3
  • Monday, 4 October

    08:00 – 10:00 | Registration

    10:00 – 11:30 | P1
    Available/Access: Virtual, In-Person

    10:00 | Welcome from Program Planning Committee Co-Chairs
    Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA
    Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio

    10:15 | Review of Emergency use for Covid-19
    Sudhakar Agnihothram, Biologist, CBER,U.S. FDA

    11:00 | Q&A Panel
    Rakesh Pandey, PhD, Chief, Regulatory Review Branch-2, CBER, U.S. FDA

    11:45 – 13:00 | Break

    13:00 – 14:30 | Concurrent Sessions

    Available/Access: In-Person Only
    Moderator: Kim R. Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

    13:00 | Strengthening the 'c' for Contamination Control - An Approach for Continuous Improvement
    Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    13:20 | Robust Contamination Control Strategies using Quality Risk Management and Quality System
    Stephen Langille, ValSource Inc.
    Danica J. Brown, QRM Consultant, ValSource Inc.

    13:45 | Implementation of Contamination Control Strategy Across the Facility in Novo Nordisk A/S
    Jette Christensen, Novo Nordisk

    14:10 | Q&A Panel

    Available/Access: In-Person Only
    Moderator: Jason L. Willett, Midwest Manager, Veltek Associates, Inc.

    13:00 | Variables Affecting Disinfectant Performance
    Dan A. Klein, STERIS

    13:20 | Microbiological Quality Control for Pharmaceutical Water by Rapid Microbiological Methods
    Yoko Nakai, Manager, HORIBA Advanced Techno, Co., Ltd.

    13:50 | Sources of Contamination Due to Flawed Barrier System Design, Cleanroom Layout or Integration
    Morgan Polen, Cleanroom, Air Flow and Particle Contamination Expert, Microrite, Inc.

    14:10 | Q&A Panel

    14:30 – 15:30 | Break

    15:30 – 17:00 | Concurrent Sessions

    Available/Access: In-Person Only
    Moderator: Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

    15:30 | Back to the Future: Where are the Rapid Methods?
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    15:55 | Implementing a Rapid Sterility Method: How we Went from Bold Idea to Completed Project at Lightspeed
    Joanny Salvas, Pfizer

    16:15 | Rapid Methods – The Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing
    Miriam Guest, Associate Principal Scientist, AstraZeneca

    16:40 | Q&A Panel

    Available/Access: In-Person Only
    Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GlaxoSmithKline Vaccines

    15:30 | Case Study using Alternative Rapid Microbial Method Scan RDI to Release Broad Spectrum Antivirals
    Omkar Baburao Patil, MSc Microbiology, Associate Director-Microbiology, Cipla Limited, Goa
    Ranjana B. Pathak, BSc, MBA, DHA, President - Global Quality, Medical Affairs & Pharmacovigilance, Cipla Limited

    16:00 | Implementation of Biofluorescence Particle Counters to Replace Traditional EM Methods
    Thais Vilgren, MSc, Principal Scientist, Global Lead Aseptic Processing, Novo Nordisk

    16:20 | Case Study: Expediting Mold Investigations with Biofluorescent Particle Counting Technology
    Dawn Watson, Merck & Co., Inc.

    16:40 | Q&A Panel

    17:00 – 18:00 | Reception

  • Tuesday, 5 October

    07:30 – 08:30 | Registration

    08:30 – 09:45 | Understanding Regulatory Expectations and Strategies to Achieve them for Pharmacy Compounding and Virtual Facility Inspections
    Available/Access: In-Person Only
    Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

    This session will focus on providing useful information related to understanding and addressing regulatory expectations for CMC and/or cGMP for pharmacy compounding and virtual facility inspections. Obstacles encountered during pharmacy compounding related to testing for potential microbial contamination will be covered. Additionally, the challenges presented by COVID-19 pandemic’s impact on the regulatory facility inspection process and the pivot to supporting virtual inspections will be discussed. Recommendations towards achieving regulatory expectations and tips to ensure they are demonstrated to regulators will be shared.

    08:30 | Overcoming the Gap Between 503A and 503B Microbiology-Related Testing
    Abby A. Roth, CMQ/OE, Senior Director of Business Operations, CriticalPoint, LLC.

    09:00 | Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

    09:20 | Q&A Panel

    10:00 – 11:30 | P2
    Available/Access: Virtual, In-Person

    11:30 – 12:45 | Break

    12:45 – 14:15 | Concurrent Sessions

    Available/Access: In-Person Only
    Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

    12:45 | New Annex 1 Facility Assessment: Case study on the Steps Towards Compliance
    Rafael Beaus, Global Consultancy Manager, Azbil Telstar

    13:15 | Designing a Contamination Control Strategy in an Aseptic Cleanroom
    James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation

    13:35 | Q&A Panel

    Available/Access: In-Person Only
    Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    12:45 | Contamination Case Studies for Sterile, Non-Sterile, Cell and Gene Therapy Products
    Ziva Abraham, Microrite, Inc.

    13:15 | Industry Representative Invited

    13:45 | Q&A

    14:15 – 15:15 | Break

    15:15 – 16:45 | Concurrent Sessions

    Available/Access: In-Person Only
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

    15:15 | Holy Crab! A Simple, Automated Sample-to-Answer Recombinant Factor C Assay for Bacterial Endotoxins
    Jay Bolden, Lilly
    Cindy Heath, Lilly

    15:40 | MAT: Understanding and Mitigating Patient Safety Risks due to Synergistic Effects of Mixed Pyrogens
    Shabnam Solati, MS, CEO, CTL-MAT

    16:00 | Implementing the QC Lab of the Future Today: Automating Endotoxin Testing for Water and Buffer Samples
    Aude J. Smeets, PhD, Analytical Technical Expert (Automation Field), GSK

    16:20 | Q&A Panel

    Available/Access: In-Person Only
    Moderator: Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

    15:15 | Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium Acnes
    Kenneth W. Boone, Director, Sterile & Microbiology Quality Assurance, Global Compliance, Merck & Co., Inc.

    15:45 | Industry Representative Invited

    16:15 | Q&A Panel

  • Wednesday, 6 October

    07:30 – 08:30 | Registration

    08:30 – 09:45 | Morning Session
    Available/Access: In-Person Only
    Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

    08:30 | Aseptic Training of Sterile Entry Personnel is Imperative to Ensure Sterility of Injectable Products
    Susan L. Ashley, PhD,
    Associate Director, Merck & Co., Inc.

    09:00 | Industry Representative Invited

    09:20 | Q&A Panel

    10:00 – 11:30 | P3
    Available/Access: Virtual, In-Person

    11:30 – 12:30 | Break

    12:30 – 14:00 | Concurrent Sessions

    Available/Access: In-Person Only
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

    12:30 | Shifting Strategies for Contamination Control – Novel Approaches for Novel Technologies
    Joseph E. McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics
    Hoang N. Phan, Distinguished Engineer, Network Technology Lead, Genentech

    12:55 | Essentials for a Sound Total Contamination Control Trending Program
    Sheba Zaman, BS, Head of Product Specialists and Training Services, Novatek

    13:25 | Q&A Panel

    Available/Access: In-Person Only

    12:30 | iLYM Media Improves Fungal Detection on the BacT/ALERT for ATMP Sterility Testing
    Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health

    13:00 | Using Machine Learning and Artificial Intelligence to Predict Microbial Risk in Cleanroom Environments
    Tamara Garcia-armisen, GSK Vaccines

    13:30 | Q&A Panel

    14:00 – 14:30 | Break

    14:30 – 16:00 | P4: Ask the Regulators
    Available/Access: Virtual, In-Person

    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 for human and animal drugs and will provide valuable perspectives from agency experts from reviewers of compounding, sterility assurance, aseptic processing, and terminal sterilization of small molecules. In addition, biotechnology professionals can seek input from agency experts on biosimilars and new molecules manufactured using biotechnology processes. Finally, expert field inspectors 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!

    14:30 | Panel Discussion
    Renée Blosser, MS, Master Microbiology Reviewer, CVM, U.S. FDA
    Rakesh Pandey, PhD, Chief, Regulatory Review Branch-2, CBER, U.S. FDA
    Regulatory Representatives Invited

    16:00 | Closing Remarks from 2022 PDA Global Conference on Pharmaceutical Microbiology Co-Chairs

Highlighted Speakers

Miriam Guest
Miriam Guest
Anna F. Lau
Anna F. Lau
National Institutes of Health
Michael J. Miller
Michael J. Miller
Microbiology Consultants, LLC
Yoko Nakai
Yoko Nakai
HORIBA Advanced Techno, Co., Ltd.
James N. Polarine, Jr.
James N. Polarine, Jr.
STERIS Corporation
Abby A. Roth
Abby A. Roth
CriticalPoint, LLC.
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences
Aude J. Smeets
Aude J. Smeets

Additional Information

  • Learning Objectives

    Learning Objectives

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

    1. 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
    2. Deepen their understanding of topics such as microbial risk, microbial control, and endotoxin testing
    3. Identify current and future trends in Microbiology
    4. Implement improvements at their own facilities using information gained through expert presentations and networking opportunities
    5. Identify regulatory and pharmacopeial expectations
    6. Understand global aspects of microbiology and aseptic processing
    7. Summarize best practices for utilizing EM data to control processes
    8. Apply some of the lessons learned by the pharmaceutical industry and regulators in a post COVID time
  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

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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.

Grand Hyatt Washington

1000 H St NW
Washington, DC

Make a Reservation
Grand Hyatt Washington
  • Accommodations

    Joining us in person? Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Grand Hyatt Washington. The rate is $309 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 6, 2021. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    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 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    With a pristine location in the heart of Washington D.C. neighborhood, just steps away from downtown, our hotel ensures that you're never far from where you're looking to go. Explore from Grand Hyatt Washington, conveniently connected to the WMATA Metro Center train station from our lobby, allowing you to travel the red, orange, silver, and blue lines with ease to the city's beloved destinations and neighborhoods. See all of D.C.'s top sights from our front doors.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 4.2 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 Airport (IAD), 27 miles away, and Baltimore-Washington International Airport (BWI), 32 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001. $42 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.

Other Options

The Hotel lobby is connected to the WMATA Metro Center train station. Metro fare from Reagan National Airport (DCA) is approximately $2.30 (one-way). To plan your trip please visit


Registration Fees

Early Registration
Registration Type Price by 31 August 2021
Member $878
Non-member $1,018
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Young Professional Member $439
Regular Registration
Registration Type Regular Registration
Price after 30 Sept. 2021
Member $1,229 $1,580
Non-member $1,425 $1,832
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Young Professional Member $615 $790

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].org.


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