Skip To The Main Content
2022 Rapid Micro Workshop

2022 PDA Rapid Microbiological Methods Workshop

Oct 12 - Oct 13, 2022
Washington, DC

Advancing the State of the Art and Transforming Innovation into Practice

  • Workshop
  • The Americas

left to register

Program Highlights

The agenda is now available!

Overview

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.

Agenda

  • Day 1
  • Day 2
  • WEDNESDAY, 12 OCTOBER

    12:00 – 17:30 | Registration

    13:30 – 15:30 | 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 | The USP Position on Modern Microbial Methods 
    John Duguid, Executive Director, Research & Development, Vericel Corporation

    14:20 | CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods
    Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

    14:40 | FDA Discussion of Alternative Methods Submissions 
    Bryan Riley, PhD, Microbiology Branch Chief (acting), CDER U.S. FDA

    15:00 | Q&A

    15:30 – 16:00 | Refreshment Break

    16:00 – 17:15 | P2: 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 USO 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!

    16:00 | Show Me the Data! An Interactive Case Study on Statistical Analyses for Rapid Methods  
    Michael J. Miller, PhD,
    President, Microbiology Consultants, LLC

    16:30 | 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

    16:50 | Q&A

    17:15 – 18:30 | Networking Reception

  • THURSDAY, 13 OCTOBER

    07:00 – 16:00 | Registration

    07:30 – 08:30 | Continental Breakfast

    08:00 – 09:30 | 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.

    08:00 | 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

    08:20 | Online Water Bioburden Analyzer Validation
    Olivia Venhuizen, MS, MPH, PhD, Process Development Scientist, Amgen

    08:40 | 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

    09:00 | Q&A

    09:30 – 10:00 | Refreshment Break

    10:00 – 11:00 | P4: 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.

    10:00 | Microbiology with Single Cell Sensitivity: The Evaluation of Confocal Raman and Cytometry
    Mehmet Davrandi, PhD, Technical Manager, Procter & Gamble

    10:20 | Real Time Capture and Detection of Microbial Contamination using Dielectrophoresis
    James Auger, Scientist, Pfizer

    10:40 | Q&A

    11:00 – 12:00 | P5: Role Play: The Implementation of a RMM at a Sterile Product Manufacturing Site

    Moderator: 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 [email protected] 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
    Kai Nesemann, PhD, Manager of Product Management Microbiology, Sartorius Lab Instruments GmbH & Co KG

    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

     

Highlighted Speakers

Ping Hu
Ping Hu
Procter & Gamble Company
Scott A. Jackson
Scott A. Jackson
National Institute of Standards and Technology (NIST)
Simleen Kaur
Simleen Kaur
U.S. FDA
Kai Nesemann
Kai Nesemann
Sartorius Lab Instruments GmbH & Co KG
Arundhati Samanta
Arundhati Samanta
Mettler Toledo
Allison A. Scott
Allison A. Scott
MicronView LLC
Oliver K. Valet
Oliver K. Valet
mibiC GmbH & Co. KG
Olivia Venhuizen
Olivia Venhuizen
Amgen

Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend
    • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation, Regulatory Affairs, Research and Development, Validation, QP
    • Level of Expertise: Senior Management, Scientists/Technicians
    • Job Function: Supervisor, Researcher, Analyst, Operative Personnel

Got a Question? We have answers

Contact Us

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.

Grand Hyatt Washington

1000 H Street NW
Washington, DC
Phone: +1 (202) 582-1234

Make a Reservation
Grand Hyatt Washington
  • Accommodations

    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 Friday, 9 September 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.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 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. Parking is available at the following rates: $45 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.

Other Options

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

Directions

Registration Fees

Regular Price
Registration Type Before Aug 14 After Aug 14
Member $1,495 $1,995
Non-Member $1,795 $2,295
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,195 $1,195

* 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].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Featured Exhibitors

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.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events

Contact

Program Inquiries
  • Brooke Lustig, CMP
    Senior Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
Exhibition Inquiries
Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

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

PDA Members Save Substantially