2022 PDA Rapid Microbiological Methods Workshop

Washington, DC
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As the pharmaceutical industry continues its fast-moving evolution, the focus on new technologies intensifies. The validation, approval, and implementation of rapid and alternative microbiological methods has also been steadily increasing within the pharmaceutical, biopharmaceutical, compounding pharmacy, and advanced therapy medicinal products (ATMP, gene and cell therapy) industries. Novel drug products and innovative manufacturing processes now require modern strategies for demonstrating microbiological control.

Attend the 2022 PDA Rapid Microbiological Methods Workshop to gain meaningful insight and practical lessons learned from actual success stories on important issues currently facing the industry. Explore 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.

This Workshop will present practical approaches to rapid microbiology testing that participants can use in daily work, laboratory, and manufacturing operations.

Upon completion of this Workshop, you will be able to:

  • Understand the benefits of alternative and RMM technologies as compared with classical microbiological methods
  • Comprehend the regulatory environment, current policies, and expectations for validation, submissions, and implementation from FDA, EMA, and other regulatory authorities
  • Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use

Standard Registration

Member Price


Early Career ProfessionalMember 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


12:00 – 17:30 | Registration

13:30 – 15:20 | P1: Beyond the Measurement: Making the Most of Rapid Microbiological Methods
Moderator: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble Technical Centres Ltd

This session will introduce the Workshop and then provide a historical, cultural, and technical perspective on the behaviors, principles, practice, and submissions associated with the adoption of Rapid Microbiological Methods. The principles associated with method use and acceptance have changed little in assessing the quality and risk for products use. However, the generation of the quality data (suitability, equivalence, and validation) does not always meet these principles. Please join our presenters as they give current perspectives and examples of what works, or doesn’t work, for Rapid Microbiological methods.

13:30 | Welcome Remarks from Workshop Chair
Michael J. Miller, PhD,
President, Microbiology Consultants, LLC

13:40 | Patterns in the Adoption of Microbiological Testing Technologies in the Pharmaceutical Industry
Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC

14:00 | CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods
Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

14:20 | FDA Discussion of Alternative Methods Submissions 
Bryan S. Riley, PhD, Branch Chief, CDER U.S. FDA

14:40 | Q&A

15:20 – 16:00 | Refreshment Break

16:00 – 17:15 | P2: The Single Cell Microbial Future: Confocal Raman, Cytometry, and Dielectrophoresis 
Moderator: Olivia Venhuizen, MS, MPH, PhD,Process Development Scientist, Amgen

Confocal Raman spectroscopy, cytometry, and dielectrophoresis are state-of-the-art alternative methods for microbial capture and detection. These technologies empower users to set limits and make actionable decisions rapidly in a new paradigm of single cell LOQ per unit volume. In this series of talks we discuss the feasibility and beta-tests that have been completed for these cost-saving novel technologies, which are also suitable for automation and rapid turn-around when compared to traditional microbiological methods. The session will explore the transformation of innovation into practice via catalytic collaborations, adaptations, and technological developments associated with these alternative RMMs.

16:00| Microbiology with Single Cell Sensitivity: The Evaluation of Confocal Raman and Cytometry
Mehmet Davrandi, PhD, Technical Manager, Procter & Gamble (confirmation sent)

16:20| Real Time Capture and Detection of Microbial Contamination using Dielectrophoresis
James Auger, Scientist, Pfizer (confirmation sent)

16:40| Q&A

17:00 – 18:00 | Networking Reception

Day 2


07:00 – 16:00 | Registration

07:15 – 08:15 | Continental Breakfast

07:45 – 09:15 | P3: Realtime Biofluorescent Detection of Microorganisms
Moderator: Lisa A. Wysocki, Microbiology Modernization Lead, GlaxoSmithKline

Bio-fluorescent particle counting (BFPC) is an alternative rapid microbiological method for monitoring microorganisms. Alternative to growth-based detection of microorganism, BFPC provides real-time detection of microorganisms based on particle count, size, and laser induced fluorescence. BFPC systems use the auto-fluorescence unit (AFU) as an alternative to the traditional colony forming unit (CFU). This session will provide information on the use of bio-fluorescent particle counting systems for detecting viable and nonviable particles from pharmaceutical environment and water systems in real-time.

07:45 | Industry Working Group Collaboration: The Benefits and Challenges Associated with Implementation of a Bio-Fluorescent Particle Counter
Allison A. Scott, PhD, Principal Scientist, MicronView LLC
Caroline E. Dreyer, Senior Specialist, Novo Nordisk

08:05 | Online Water Bioburden Analyzer Validation
Olivia Venhuizen, MS, MPH, PhD, Process Development Scientist, Amgen

08:25 | Two Case Studies on the Successful Use of Air and Water Based Bio-Fluorescent Particle Counters for Environmental Monitoring and Troubleshooting Applications
Arundhati Samanta, MA, MBA, Global Product Manager, Mettler-Toledo
James Francis, Technical Director, Micron View LLC

08:45 | Q&A

09:15 – 09:45 | Refreshment Break

09:45 – 11:00 | P4: Don’t Be Scared of Statistics: Case Studies on How to Handle Your Rapid Method Validation Data
Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

The use of statistics in evaluating data during a rapid microbiological method validation is now the standard expectation. Guidance on the use of statistical models has been provided in various validation documents such as USP 1223, Ph. Eur. 5.1.6 and PDA Technical Report #33. This session will provide examples of how to practically use statistics when evaluating a quantitative or qualitative rapid method and comparing the recovery of microorganisms to the existing conventional or compendial test method.

The first presentation will explore statistical methods for non-inferiority, sample size calculation, and goodness-of-fit when multiple microorganisms are challenged in the rapid and conventional methods. The next presentation will be a hands-on demonstration of how to use statistical software when demonstrating equivalence, where you the audience, will provide the data in real time!

09:45 | Show Me the Data! An Interactive Case Study on Statistical Analyses for Rapid Methods
Michael J. Miller, PhD, President, Microbiology Consultants, LLC

10:15 | Non-Inferiority on the Detection Probability of a Rapid Microbiological Method using Multiple Types of Microorganisms
Edwin van den Heuvel, PhD, Professor of Statistics, Eindhoven University of Technology

10:35 | Q&A

11:00 – 12:00 | P5: Role Play: The Implementation of a RMM at a Sterile Product Manufacturing SiteModerator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

Ever wonder how a cross-functional team discusses the benefits and challenges with the validation and implementation of a rapid method? In this session, we will observe the interactions between our microbiology lab manager, a Quality Assurance associate, a production manager and the Site Head, in an exciting role play presentation. After hearing the positions from each of the contributors, and a follow up "debate," audience members will have an opportunity to provide their point of view. If you have served in any of these roles, we will want to hear your experiences!   

11:00 – 11:15 | Introduction of Session and Players
Michael J. Miller, PhD,
President, Microbiology Consultants, LLC

11:15 – 11:45 | Role Play Presentation
Kevin I. Wright, PhD,
Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble Technical Centres Ltd
Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC
Sven M. Deutschmann, Head of Global Analytical Science & Technology "Adventitious Agents Testing & Alternative Microbiological Methods", Global QC, Roche Diagnostics GmbH
Erika Pfeiler, FDA

11:45 – 12:00 | Audience Participation, Additional Commentary, and Wrap Up
Michael J. Miller, PhD, President, Microbiology Consultants, LLC

12:00 – 13:00 | Lunch

13:00 – 14:15 | P6: Alternative Microbiological Methods for (Near) Real-Time Release
Moderator: Sven M. Deutschmann, Head of Global Analytical Science & Technology "Adventitious Agents Testing & Alternative Microbiological Methods", Global QC, Roche Diagnostics GmbH

Alternative, Rapid Microbiological Methods (RMM) continue to gain acceptance within the industry. With the introduction of this technology, we want to realize significant gains in automation, throughput, and time to result. The introduction of RMM as part of the microbial control concept is seen as a key technology and contributor to Instant-Release or (Near) Real-Time-Release. New microbiological technologies enable us to reduce drastically the time to result, which contributes to reduced QC lead times and improve data integrity with elimination of transfer errors by direct LIMS connection and direct capturing of electronic raw data. The methods and readout technologies presented in this session are promising tools, for example to reduce the analytical lead time of the classic sterility test carried out in the QC laboratory from 14 days to a few days, or they could even be used as online tools directly on the shop floor as part of the manufacturing process and thus control the manufacturing process directly as process analytical technology (PAT).

13:00 | Mango’s Automated Compendial Near Real-Time Platform, a Revolution in Microbial Quality Control
Robin Ross, PhD, Head of Research, Mango Inc.

13:15 | Primary Validation of the AQU@Sense MB for the Online Bioburden Analysis of Pharmaceutical Waters
Pierre Balidas, Head of Research and Development, BWT Pharma & Biotech Inc

13:30 | Rapid Microcalorimeter Phenotypic Method for Simultaneous Detection and Speciation of Microorganisms Contaminating ATMPs
Wilhelm Paulander, PhD, Director, Application Development, Symcel

13:45 | The Groundwork to RTR: Current Developments in Microbiological Sample Preparation from Complex Matrices for Raman Spectroscopic Count & ID
Oliver K. Valet, PhD, Managing Director, mibiC GmbH & Co. KG

14:00 | Validation Study of a qPCR-Based Rapid Sterility Test for Final Release of Short Shelf-Life ATMPs
Miriam Dormeyer, Sartorius Lab Instruments GmbH & Co KG
Yasmin Heynen, Labor LS

14:15 – 14:45 | Refreshment Break

14:45 – 16:15 | P7: Saying Goodbye to Conventional Methods and the Future of Standardizing Rapid Methods
Moderator: Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC

In this final session of the workshop, case studies from Joleen Simpson will describe her company’s experience with the application of the MycoSeq Mycoplasma Detection Kit, replacing the compendial growth-based method for the lot release of biopharmaceutical drug products, and Ping Hu will describe the application of the emerging technology Nanopore Long Reads Sequencing for the rapid speciation of microorganisms and how it facilitates microbial contamination risk assessment during manufacturing. 

Concluding the workshop presentations, Scott Jackson and Kristen Parratt will described the activities of the NIST-sponsored industry consortium to develop certified reference strains of microorganisms for RMMs. As the industry transitions from traditional growth-based methods based on the colony-forming unit to modern microbial methods with analytical signals these reference strains will be characterized by their genomic material, bio-fluorescence, ATP content, and other chemical fingerprints for be useful in method validation, method suitability testing, controls for routine testing. The presentation will describe the consortium progress in standardizing analytical methods and organizing interlaboratory collaborative studies. 

Lastly, the RMM Workshop Chair, Michael Miller, will make his concluding remarks on how the workshop has meet the objectives of advancing the RMM state of the art and transforming these innovations into routine practice. He will address our successes and future challenges.

14:45 | Optimization and Use of the MycoSEQ Mycoplasma Detection Kit for Lot Release  
Joleen S. Simpson, MS, Principal Biologist, Eli Lilly and Company

15:05 | Using Nanopore Long Reads Sequencing Technology for Rapid Microbial Species Detection and Risk Assessment    
Ping Hu, PhD, Principal Scientist, Procter & Gamble Company

15:25 | The NIST-Led RMTM Consortium:  An Overview of Consortium Activities and Technical Progress Towards Standards Development for RMTMs
Scott A. Jackson, PhD, Leader: NIST Microbiology Program,National Institute of Standards and Technology (NIST)
Kirsten Parratt, PhD, Biomedical Engineer, National Institute of Standards and Technology (NIST)

15:45 | Q&A

16:05 | Closing Remarks from Workshop Chair  
Michael J. Miller, PhD, President, Microbiology Consultants, LLC


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.

Grand Hyatt Washington

1000 H Street NW
Washington, DC ,

+1 (202) 582-1234

The Grand Hyatt Washington Hotel is now sold out! While there are no other Conference room blocks, we recommend checking the following hotels for rooms as they are the closest walkable hotels with availability.

  1. Conrad Washington, DC Hotel (4 min. walk to Grand Hyatt)
  2. Moxy Washington, DC Downtown Hotel (5 min. walk to Grand Hyatt)
  3. Fairfield Inn & Suites by Marriott Washington, DC/Downtown Hotel (9 min. walk to Grand Hyatt)
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. Parking is available at the following rates: $45 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.