2022 PDA Rapid Microbiological Methods Workshop
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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
Agenda
Discover What's Happening Each Day
WEDNESDAY, 12 OCTOBER
12:00 – 17:30 | Registration
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13:30 – 15:20 | P1: Beyond the Measurement: Making the Most of Rapid Microbiological Methods |
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13:30 | Welcome Remarks from Workshop Chair 13:40 | Patterns in the Adoption of Microbiological Testing Technologies in the Pharmaceutical Industry 14:00 | CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods 14:20 | FDA Discussion of Alternative Methods Submissions 14:40 | Q&A |
15:20 – 16:00 | Refreshment Break
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16:00 – 17:15 | P2: The Single Cell Microbial Future: Confocal Raman, Cytometry, and Dielectrophoresis |
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16:00| Microbiology with Single Cell Sensitivity: The Evaluation of Confocal Raman and Cytometry 16:20| Real Time Capture and Detection of Microbial Contamination using Dielectrophoresis |
17:00 – 18:00 | Networking Reception
THURSDAY, 13 OCTOBER
07:00 – 16:00 | Registration
07:15 – 08:15 | Continental Breakfast
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07:45 – 09:15 | P3: Realtime Biofluorescent Detection of Microorganisms |
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07:45 | Industry Working Group Collaboration: The Benefits and Challenges Associated with Implementation of a Bio-Fluorescent Particle Counter 08:05 | Online Water Bioburden Analyzer Validation 08:25 | Two Case Studies on the Successful Use of Air and Water Based Bio-Fluorescent Particle Counters for Environmental Monitoring and Troubleshooting Applications 08:45 | Q&A |
09:15 – 09:45 | Refreshment Break
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09:45 – 11:00 | P4: Don’t Be Scared of Statistics: Case Studies on How to Handle Your Rapid Method Validation Data 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! |
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09:45 | Show Me the Data! An Interactive Case Study on Statistical Analyses for Rapid Methods 10:15 | Non-Inferiority on the Detection Probability of a Rapid Microbiological Method using Multiple Types of Microorganisms |
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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 |
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11:00 – 11:15 | Introduction of Session and Players 11:15 – 11:45 | Role Play Presentation 11:45 – 12:00 | Audience Participation, Additional Commentary, and Wrap Up |
12:00 – 13:00 | Lunch
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13:00 – 14:15 | P6: Alternative Microbiological Methods for (Near) Real-Time Release |
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13:00 | Mango’s Automated Compendial Near Real-Time Platform, a Revolution in Microbial Quality Control 13:15 | Primary Validation of the AQU@Sense MB for the Online Bioburden Analysis of Pharmaceutical Waters 13:30 | Rapid Microcalorimeter Phenotypic Method for Simultaneous Detection and Speciation of Microorganisms Contaminating ATMPs 13:45 | The Groundwork to RTR: Current Developments in Microbiological Sample Preparation from Complex Matrices for Raman Spectroscopic Count & ID 14:00 | Validation Study of a qPCR-Based Rapid Sterility Test for Final Release of Short Shelf-Life ATMPs |
14:15 – 14:45 | Refreshment Break
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14:45 – 16:15 | P7: Saying Goodbye to Conventional Methods and the Future of Standardizing Rapid Methods 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. |
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14:45 | Optimization and Use of the MycoSEQ Mycoplasma Detection Kit for Lot Release 15:05 | Using Nanopore Long Reads Sequencing Technology for Rapid Microbial Species Detection and Risk Assessment 15:25 | The NIST-Led RMTM Consortium: An Overview of Consortium Activities and Technical Progress Towards Standards Development for RMTMs 15:45 | Q&A 16:05 | Closing Remarks from Workshop Chair |
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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.
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.
- Conrad Washington, DC Hotel (4 min. walk to Grand Hyatt)
- Moxy Washington, DC Downtown Hotel (5 min. walk to Grand Hyatt)
- Fairfield Inn & Suites by Marriott Washington, DC/Downtown Hotel (9 min. walk to Grand Hyatt)
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Pricing Options
Standard Registration
Member Price
$1,995Early Career ProfessionalMember Only
$1,195
Non-Member
$2,295
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 registration@pda.org.
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