2023 PDA Pharmaceutical Microbiology Conference

Washington, DC
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Program Highlights

The conference will be followed by the interactive 2023 PDA Microbial Data Deviation Investigations Workshop!

The 2023 PDA Pharmaceutical Microbiology 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.


  • Kurt Jaecques, GSK (Co-Chair)
  • Vineeta Pradhan, U.S. FDA (Co-Chair)
  • Frederic Ayers, ValSource, Inc.
  • Daniel Bice, Teva
  • Yeissa Chabrier-Rosello, U.S. FDA
  • Lori Daane, bioMérieux, Inc.
  • Lynne Ensor, Parexel
  • Mitch Garber, 2seventy bio
  • Marc Glogovsky, ValSource, Inc.
  • Simleen Kaur, U.S. FDA
  • Heike Merget-Millitzer, J&J
  • Dawn Watson, Merck & Co., Inc.
  • Jason Willett, Veltek Associates

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.

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].

Day 1


14:00 – 19:00 | Registration Open


07:30 – 17:30 | Registration Open

07:30 – 08:30 | Continental Breakfast

08:30 – 10:00 | P1: Patient Perspective
Moderator: Mitch B. Garber, RPh,
President, MG Aseptic and Quality Assurance Consulting

Rob Weker worked his entire career in healthcare and is a three-time cancer survivor. In this patient perspective opening plenary, he will share his pancreatic cancer journey, from diagnosis through treatment. Rob will detail how he and his family made many difficult treatment decisions while having continuous challenges from his medical insurance company. He will also describe his thought process and decision to go against the wishes of his family, and the advice of several doctors, to enter a clinical trial study, which he believes ultimately saved his life.

Everyone has been touched somehow by cancer, either directly or indirectly, which drives Rob’s passion to share his learnings and journey with everyone he can. His hope is to influence and motivate the scientists and regulatory professionals at this PDA event with his message.

08:30 | Opening Remarks from Conference Co-Chairs
Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
Vineeta A. Pradhan, PhD, Microbiologist, ONADE, CVM, U.S. FDA

08:40 | A Cancer Journey as Seen Through the Patient Lens
Rob Weker, MBA, Principal, Weker Advisors

09:20 | Q&A

10:00 – 10:45 | Networking Break

10:45 – 12:15 | Concurrent Sessions

A1: Isolators and Critical Zones: Optimal Strategies for Decontamination and Sterilization
Moderator: Dawn Watson,
Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.

While the use of isolators significantly reduces the risk of contamination, conventional aseptic processing areas are still widely used today. It is imperative to maintain strict control of these environments, which is in part accomplished through a robust cleaning and disinfection program that utilizes sterilized or pre-sterile disinfection agents. This session will describe the essential elements of sterility validation for irradiated disinfection supplies and agents and how to reduce the risk of contamination while considering their chemical stability once opened.

For such an impactful technology with decades of history, implementation of isolators has been regrettably slow. One of the major obstacles to isolator technology is validation of the vapor phase hydrogen peroxide (VPHP) decontamination cycle. This session will provide insights into recommended best practices for VPHP cycle development from an industry collaboration, an introduction to enzyme indicators, and strategies to optimize cycle validation for robust, effective, and more efficient decontamination cycles.

10:45 | Sterility, Sterilants, and Sterilization
Mark Wiencek, PhD, 
Principal Microbiologist, Contec, Inc.

11:15 | BioPhorum Isolator Good Operating Practices Team: Industry Guidance for Vapor Phase Hydrogen Peroxide Cycle Development
Terrence Hollis,
Senior Manager, Global Technology and Engineering, Pfizer Inc.

11:35 | Optimizing Decontamination Cycles for Aseptic Processing Isolators
Joseph E. McCall, Jr., SM (NRCM),
Director, QA Technical Services, ADMA Biologics

11:55 | Q&A

B1: Elements of Effective and Robust Microbiology Laboratory Investigations
Moderator: Heike Merget-Millitzer, PhD,
Microbiology CoE Lead, J&J

Inadequate performance and documentation of investigations represent a large proportion of observations from health authorities. In this session, the presenters will discuss best practices and examples for conducting effective and robust microbiology laboratory investigations in support of a thorough root cause analysis. Elements to consider for bioburden investigations in non-sterile manufacturing as well as for environmental monitoring (EM) limit excursions will be addressed. The importance of identifying the type of contaminant to determine the root cause and to define respective remediation measures will also be highlighted.

10:45 | Bioburden Investigations in Non-sterile Biologics Processing
Duncan Ross,
Associate Director QC Microbial Control, Lonza Biologics

11:05 | Get Out from Behind Your Computer to Conduct Comprehensive EM Investigations
Jaime Kaho'ohanohano,
Senior Microbiology Consultant, Microrite Inc.

11:35 | Investigating Cleanroom Contamination and Disinfection Strategies
Dan A. Klein,
Sr. Technical Service Manager, STERIS Corporation

11:55 | Q&A

C1: Endotoxins and Pyrogens: Next Generation Testing Platforms
Moderator: Simleen Kaur, MSc,
Biologist, Team Lead, OCBQ, CBER, U.S. FDA

It is time to remove barriers and adopt innovative platforms for detection of Endotoxins and Pyrogens during production and testing of pharmaceutical products. The proven efficacy of the modern methods provides an opportunity for the pharmaceutical industry to modernize traditional procedures and contribute significantly to the conservation of animals. This session will focus on evaluation of Recombinant Factor C and Monocyte Activation Test for safety testing during manufacturing and release of products.

10:45 | Characterization of Endotoxin-Detecting rFC Products for Evaluation of Manufacturing Quality and Assay Performance
Talia Faison, MS, CQA, Biologist, Product Quality Research-Reviewer, OPQ, CDER, U.S. FDA

11:05 | Suitability of rFC-Based Endotoxin Tests: A Comparison Study Including Different Pharmaceutically-Relevant Grades of Water
Andre Kriegeskorte, PhD,
Global Expert Microbiology, GSK

11:25 | MAT: A Case Study from Method Development and Validation to Release Testing of Drug Products
Maria Gajewi,
Manager Endotoxin Services, Microcoat Biotechnologie GmbH
Jonas van den Berg, Global Quality Manager, Roche Diagnostics GmbH

11:55 | Q&A

12:15 – 13:45 | Grand Opening of the Exhibit Hall, Networking Lunch, Exhibitor Tech Talks, and Poster Presentations

Exhibitor Tech Talks

12:25 – 12:35 | BIOFIRE® MYCOPLASMA: Testing by Anyone, Anywhere, Anytime
Stanely Bonn,
Business Development Manager- Rapid Microbiology, bioMérieux, Inc.

12:40 – 12:50 | Want to Standardize the Results of the BET Assay? Here is How!
Veronika S. Wills, MSc,
Associate Director, Global Technical Services, Associates of Cape Cod, Inc.

12:55 – 13:05 | The Wait is Over: Introducing Endosafe Trillium rCR
Nicola Reid,
Associate Director of Endotoxin Products, Charles River

13:10 – 13:20 | Sievers Soleil: Bioburden Results in Under an Hour
Meg Provenzano,
Product Manager-Biodetection, Veolia Analytical Instruments

13:45 – 15:15 | Concurrent Sessions

A2: Reflecting on "Microbiology Testing of the Future"
Moderator: Kurt Jaecques, MA,
Global Aseptic Technologies Lead Monitoring & Control, GSK

Reflecting on "microbiology testing of the future", our first thoughts guide us towards implementation of rapid microbial methods (RMM) to allow fast release of microbial quality control (QC) testing results. Whilst this should indeed be one of the main goals, it is not the only one. Of equal importance is the immediate access to data in the right format. Finally, within this lab of the future, we will need competent microbiologists with the ability to follow this evolution and make the right decisions quickly and effectively. In this session, the presenters will cover these three aspects by looking at an RMM for mycoplasma, how we can efficiently access and trend our data, and finally how we can build and ensure the right competencies for our microbiology experts of the future.

13:45 | Implementation of a Novel Mycoplasma Testing Technology to Increase Automation and Real-Time-Release
Heike Merget-Millitzer, PhD,
Microbiology CoE Lead, J&J

14:05 | A Novel Method to Extract Environmental Monitoring (EM) Data from Paper Records for Use in Monitoring and Trending
Jon R. Voss, MS, VP, Head of Quality, Abeona Therapeutics
Clare Gollnick, PhD, CTO & Co-Founder, Fathom Data

14:30 | Pharmaceutical Microbiologists: Training for Competency in the Next Decade and Beyond
Donald C. Singer, MA, ASQ Fellow, CPGP,
Senior Microbiology Technical Consultant, North America, Ecolab
Radha Tirumalai, PhD, Senior Principal Scientist, Merck & Co., Inc.

14:55 | Q&A

B2: Aseptic Manufacturing: Sterile Compounding to BLAs/Biosimilars and Some Regulatory Considerations
Moderator: Yeissa M. Chabrier-Rosello, PhD,
Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

Aseptic manufacturing from the perspective of sterile compounding, biologics and biosimilars and some of the regulatory oversight involved with these processes will be discussed in this session. The session will cover the new updates to USP<797>, including the new compounding categories, beyond-use dates and some of the significant microbiological testing revisions. Discussion of current challenges with aseptic manufacturing processes for biologics and biosimilars from a regulatory perspective via case studies will be covered as well as an overview of the regulatory oversight for compounded drugs, from a historical perspective related to patient safety, and discussion of current inspectional case studies.

13:45 | Sterile Compounding: Clarity from Chaos
Abby A. Roth, CMQ/OE,
Owner/Microbiologist, Pure Microbiology, LLC

14:05 | Sterile Filtration of Biological Products
Reyes Candau-Chacon, PhD, Microbiologist, OPQ, CDER, U.S. FDA

14:25 | FDA Oversight of Compounded Drugs
CDR Chad N. Thompson,
Program Management, OMPTO, ORA, U.S. FDA

14:45 | Q&A

C2: Endotoxin Masking: Contributing Factors and Mitigation Strategies
Moderator: Moderator: Josh Eaton, MS,
Director, Scientific and Regulatory Affairs, PDA

Low recovery or masking of endotoxins has been reported in a variety of publications and assessment of the potential for low endotoxin recovery (LER) is a requirement within BLAs for specified biologics. This session will provide an overview of the LER phenomenon based on numerous case studies, an in-depth look at possible contributing factors, including container effects and processing steps, and considerations and approaches to mitigate the occurrence of LER and facilitate endotoxin removal throughout the manufacturing process.

13:45 | Overcoming Low Endotoxin Recovery: From Theory to Practice
Jessica V. Hankins, PhD,
Associate Scientific Director, Bristol Myers Squibb

14:10 | The Impact of Endotoxin Masking on the Removal of Endotoxin during Manufacturing of a Biopharmaceutical Drug Product
Jessica Stolzenberger,
Associate Director Late Stage Downstream Development, Boehringer Ingelheim GmbH & Co. KG

14:30 | Endotoxin Masking: Dependency on Container Type and Material
Bernhard Illes, PhD,
Project Leader Endotoxin Services, Microcoat Biotechnologie GmbH

14:55 | Q&A

15:15 – 16:00 | Networking Break (sponsored by Charles River), Exhibitor Tech Talks, and Poster Presentations in the Exhibit Hall

Exhibitor Tech Talks

15:25 – 15:35 | Detecting Contaminants, Ensuring Purity: A Closer Look at Our New High-Performance Mycoplasma Testing Solution
Mihir Rajhansa,
Scientist ll, Molecular Biology, BioProduction Group,Thermo Fisher Scientific

16:00 – 17:00 | P2: Connecting the Dots Between Spillover and Disease Emergence
Moderator: Frederic B. Ayers,
Senior Consultant, ValSource, Inc.

Dr. David Kennedy is an Assistant Professor of Biology studying pathogen ecology at The Pennsylvania State University. In this session, he will discuss pathogen spillover and the challenges associated with experimentally studying spillover in the lab. According to Dr Kennedy, pathogens spillover into humans frequently but understanding “the likelihood that a virus will be transmissible in a new host is hugely challenging, especially with the replication needed to gain scientific insight.” Dr. Kennedy will also present his research model of using nematodes as a unique host organism and how this model has promise to predict future crossovers before they develop into global pandemics.

16:00 | "Crawling" Towards a Predictive Framework for Host Jumps and Pandemics
David Kennedy, PhD,
Assistant Professor of Biology, The Pennsylvania State University

16:30 | Q&A

17:00 – 18:00 | Networking Reception in the Exhibit Hall (Sponsored by Veolia WTS - Sievers Instruments)

Day 2


07:30 – 18:00 | Registration Open

07:30 – 09:00 | Continental Breakfast

07:45 – 08:45 | Microbiology/Environmental Monitoring Interest Group
IG Leaders: Kurt Jaecques, MA,
Global Aseptic Technologies Lead Monitoring & Control, GSK and Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.

09:00 – 10:00 | P3: The Journey of Quality Intelligence: A Roadmap to Compliance in the 21st Century
Moderator: Vineeta A. Pradhan, PhD,
Microbiologist, ONADE, CVM, U.S. FDA

How does one establish a true risk-based approach for pharmaceutical manufacturing? This plenary session will focus on risk management and data governance. With the help of case studies, Peter Baker will explore factors that hinder implementation of regulatory expectations for both human and animal medical products. He will also present potential solutions to overcome inherent biases and experiences through critical thinking resources, as well as highlight simple tools to help meet the ultimate goal of knowledge management.

09:00 | Critical Thinking in a Regulated Environment
Peter E. Baker, MS, President, Live Oak Quality Assurance

09:30 | Q&A

10:00 – 10:45 | Networking Break and Poster Presentations in the Exhibit Hall

10:45 – 12:15 | Concurrent Sessions

A3: Monitoring Efficiencies and Contamination Control Strategies
Moderator: Daniel Bice,
Associate Director Microbiologist Quality Compliance, Teva

This session will encompass a quality risk management (QRM) tool to establish risk-based bioburden programs based on guidance principles in ICHQ11 and USP <1115> and their application to the facility and bioburden program. Additionally, how to create a robust global contamination control strategy and effectively implementing the aligned vision and the challenges with it to each site will be discussed.

10:45 | Establishing a Risk-Based Bioburden Control Program in a Low Bioburden API Production
Peter Bisp, MA,
QA Specialist, Novo Nordisk A/S

11:10 | Starting with the End in Mind: How to Implement a Multi-Site CDMO Contamination Control Strategy
Marsha L. Steed,
Head of Corporate Microbial Control and Viral Safety, Resilience

11:35 | Q&A

B3: Challenges and Opportunities for Aseptic Processing for Multiple Modalities including ATMPs
Moderator: Frederic B. Ayers,
Senior Consultant, ValSource, Inc.

Cleanrooms are engineered areas designed to minimize proliferation of microorganisms and to maintain low concentration of airborne particles. These are essential for industrial production, and are also designed to control other environmental parameters, such as temperature, humidity, and pressure. In this session, there will be two different journeys discussed along with a review of current regulatory inspection and enforcement trends for aseptic processing.

10:45 | The Journey to Build a Clinical Cell and Gene Therapy Facility
Mitch B. Garber, RPh,
President, MG Aseptic and Quality Assurance Consulting

11:15 | Current Regulatory Inspection and Enforcement Trends for Aseptic Processing
Stephen E. Langille, PhD,
Senior Microbiology Consultant, ValSource, Inc.

11:40 | Q&A

12:15 – 13:45 | Networking Lunch and Poster Presentations in the Exhibit Hall

13:45 – 15:15 | Concurrent Sessions

A4: ATMPs: Translating Bench Development to a Controlled Manufacturing Process
Moderator: Simleen Kaur, MSc,
Biologist, Team Lead, OCBQ, CBER, U.S. FDA

Advanced therapeutic medicinal products (ATMPs), “next generation” pharmaceuticals, offer novel technologies for new options for disease treatments based on cells, gene therapy, or tissue replacement. However, due to the diversity of product types and unique manufacturing processes, maintaining aseptic practices and monitoring quality of ATMPs have been a challenge. This session will focus on different approaches for developing microbial control strategies and establishing good aseptic practices for successful production of ATMPs under good manufacturing process.

13:45 | Establishing a Microbial Contamination Testing Strategy for Live Biotherapeutic Products: Regulatory Requirements, Practical Experience, and Future Development Opportunities
Joey Stair, MEng,
Manager, Quality Assurance, Rise Therapeutics

14:05 | The Power of High-Resolution Risk Data: Holistic ATMP Contamination Control Strategy
Sebastian Scheler,
Managing Director, Innerspace GmbH

14:30 | The Myth of the "Non-GMP" Space: The Criticality of Establishing Good Aseptic Practices in the Development Environment
Amanda Curtis,
Microbiology Consultant, ValSource, Inc.

14:55 – 15:15 | Q&A

B4: Contamination Control in Annex 1: Two Case Studies
Moderator: Kurt Jaecques, MA,
Global Aseptic Technologies Lead Monitoring & Control, GSK

The Annex 1 revision clarified expectations on multiple aspects of contamination control while also stirring debate on the correct implementation. The use of quality risk management (QRM) principles and, more specifically, the requirement to generate a documented contamination control strategy (CCS) triggered many questions. How should one structure this document and how it can help drive continuous improvement of your processes? The revision also reignited discussions on the rotation of disinfectants. In this session, the presenters will discuss a case study on the use of risk assessment and will evaluate surface environmental monitoring (EM) data from different pharmaceutical organizations to evaluate a possible suitable disinfectant rotation strategy.

13:45 | Case Study on the Implementation of Annex 1 Risk Assessment Requirements
Hilary A. Chan, MS, Principal Scientist, Takeda

14:15 | Collaborating to Innovate Effective Disinfectant Rotation for Contamination Control
Laura Brennan
, European Technical Consulting Leader, Ecolab
Terra Kremer, Director of Microbiological Quality, Johnson & Johnson 

14:40 | Q&A

15:15 – 16:00 | Networking Break and Poster Presentations in the Exhibit Hall

16:00 – 17:45 | Concurrent Sessions

A5: Avoiding the "Spray and Pray" Approach to Environmental Monitoring
Moderator: Marc Glogovsky, MS
Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.

Cleanroom environments supporting the manufacture of drug substances and drug products require strict control to minimize the potential for microbiological and particulate contamination of the product. Therefore, it is important to have a robust process for the establishment of an environmental monitoring (EM) program and its qualification.

This session will walk through the process of establishing and implementing the baseline EM program starting from the EM performance qualification (EMPQ), continuing through to selection of sample locations and frequencies, and concluding with implementation of the routine monitoring program. Presentations will focus on a risk-based approach following quality risk management (QRM) principles, expanding the “living” program to other sites within a firm’s organization as well as optimization of site selection.

16:00 | What Really is Risk-Based EM?
Frederic B. Ayers,
Senior Consultant, ValSource, Inc.

16:25 | Case Study: Application of Industry Harmonized Approach to EM Performance Qualification
Dawn Watson,
Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.
Manshi V. Patel, Associate Director, Merck & Co., Inc.

16:50 | Case Studies on Implementing a Global Risk-Based EM Approach Across a Range of Production Facilities
Jeremy Balster,
Quality Control Microbiology Manager, Takeda

17:15 | Q&A

B5: On Your Mark, Get Set, Disinfect!
Moderator: Jason L. Willett,
Midwest Manager, Veltek Associates, Inc.

Disinfection can seem like a never-ending race against microorganisms, but with proper planning and preparation, facilities can take the checkered flag. During this session, the presenters will dive into the fundamentals of disinfectant efficacy testing with an emphasis on method development, establishing acceptance criteria and performing the method. A new, non-UV antimicrobial light technology that allows for lights-on, around-the-clock disinfection with a case study showcasing environmental monitoring data before and after installation of the antimicrobial lights will also be explored. The final presentation will examine ways to mitigate the subjectivity surrounding disinfectant qualification with the goal of developing a successful, scientific based cleaning and disinfection program.

16:00 | Fundamentals of Disinfectant Efficacy Testing
Crystal M. Booth, MM, ASQ-CQE, PMI-PMP,
Sr. Technical Director, PSC Biotech

16:25 | Case Study: Effectiveness of Non-UV Anti-Microbial Light in Pharmaceutical Manufacturing Clean Room Gowning Area and Further Applications
Victoria Raburn,
Manager, Environmental Compliance, Pfizer Inc.

16:45 | Disinfectant Qualification: A Subjective Test
Ziva Abraham, PhD,
CEO, Microrite, Inc

17:15 | Q&A

Day 3


07:15 – 12:45 | Registration Open

07:15 – 08:45 | Continental Breakfast

07:30 – 08:15 | Breakfast Session: USP Microbiological Standards
Moderator: Lynne Ensor A. Ensor, PhD,
Senior Vice President & Head of Global Compliance Consulting, PAREXEL

Practical and relevant standards firmly based in current scientific knowledge are critical to the continued assurance of the supply of quality drugs and devices. The United States Pharmacopeia (USP) is focused on providing such standards in its continuing work in key areas of importance including: endotoxins and pyrogens, rapid (modern) microbiological methods, bioburden contamination testing, microbial control, and sterility assurance. This session will provide an update on the current work plan of the USP General Chapters Microbiology Expert Committee and its related subcommittees. Included in this session will be an outline of the current priorities and future plans for the development of related standards, best practices for sterility assurance and microbial control, and stakeholder engagement opportunities. Additionally, a brief refresher regarding the USP standard setting process, including opportunities for stakeholder engagement identified, will be discussed.

07:30 | An Overview and Update on Future Plans
Mark G. Schweitzer, PhD, Principal, Mark Schweitzer Consulting LLC

07:50 | Q&A

08:30 – 10:00 | P4: Fraud and Deception in Science
Moderator: Lori Daane, PhD,
Sr Director of Scientific Affairs, bioMérieux, Inc.

Science builds upon science. How we design experiments and gain knowledge to improve patient health and safety depends on peer-reviewed publications. But can we believe everything we see? Papers that contain incorrect, or even falsified, data and manipulated images lead to wasted time and money spent by other researchers trying to reproduce those results. This in turn causes delays in the development of successful drugs and treatments. Several high-profile science misconduct cases have been reported, but many more cases remain undetected.

Meet Elisabeth Bik, an image forensics detective who left her paid job in industry to search and report biomedical articles that contain errors or data of concern. She has done a systematic scan of 20,000 papers in 40 journals and found that about 4% of these papers contained inappropriately duplicated images. In her presentation, she will describe her work and show several types of inappropriately duplicated images and other examples of research misconduct. In addition, she will share how to report scientific papers of concern, and how journals and institutions handle such allegations.

08:30 | Image Duplication, Manipulation, and Other Types of Problems in Biomedical Research
Elisabeth M. Bik, PhD,
Senior Consultant, Harbers Bik LLC

09:15 | Q&A

10:00 – 10:30 | Networking Break

10:30 – 12:15 | P5: Ask the Regulators Panel Discussion
Moderators: John W. Metcalfe, PhD,
Master Microbiology Reviewer, OPQ, CDER, U.S. FDA and Vineeta A. Pradhan, PhD, Microbiologist, ONADE, CVM, U.S. FDA

During this interactive session, U.S. FDA representatives 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 who assess microbiological quality of non-sterile and sterile drugs and biologics. The panel members have extensive experience in several areas pertaining to product sterility assurance, including terminal sterilization, aseptic processing, and compounding. In addition, expert field investigators 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 | Panel Discussion
Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, OPQO, ORA, U.S. FDA
Colin L. Davis, PhD, Biologist, ONADE, CVM, U.S. FDA 
Jennifer Del Valle Ortiz, MS, Supervisory Consumer Safety Officer, OCQC, CDER, U.S. FDA
CDR Donald B. Ertel, MS, MT (ASCP), Regulatory Officer, OCBQ, CBER, U.S. FDA
Brooke K. Higgins, MS, Acting Branch Chief, OC, CDER, U.S. FDA
Tiffany Lucas, PhD, Gene Therapy CMC Reviewer, OTP, CBER, U.S. FDA

12:00 | Closing Remarks from the 2024 PDA Pharmaceutical Microbiology Conference Co-Chairs

Agenda is subject to change.

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.

The Grand Hyatt Washington is the headquarter hotel for the 2023 PDA Pharmaceutical Microbiology Conference!

The Conference hotel room block is closed. We recommend calling the Grand Hyatt for reservations or booking online for the best available rate.


Phone: +1 (202) 582-1234
Click on the reservation link above

The Grand Hyatt Washington is located in downtown Washington, DC, just blocks away from the National Mall. Immerse yourself in the historic sights, shopping, and alluring nightlife of the nation's capital. Whether you're visiting for business or pleasure, you'll enjoy exceptional comfort and service, as well as a direct connection to the city via the Metro Center station.
How to Get Here
By Air The airports closest to the Grand Hyatt Washington hotel are Reagan National Airport (DCA, 3.6m/5.8km), Dulles International Airport (IAD, 25.3m/40.7km), and Baltimore-Washington International Airport (BWI, 31.5m/50.7km).
By Car The Grand Hyatt Washington hotel is located at 1000 H Street NW, Washington, DC 20001. Both self-parking ($12-45+/day) and valet parking ($34-65+/day) are available.