2020 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 2020 PDA Rapid Microbiological Methods Workshop virtually 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.

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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

Thursday, October 22

10:00 a.m. – 11:45 a.m. | P1: Case Studies on Method Suitability and Validation
Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA

We have all heard so much about the barriers to adopting rapid microbiological methods – technological issues, expense, regulatory compliance – so why should the microbiologists take on the hassle of advocating for them in their organizations? This session highlights the expanding usefulness of rapid methods to demonstrate microbiological quality for a variety of products. The speakers have each dealt with and overcome the barriers to adoption, worked towards successful implementation of a rapid method, and are here to share their experiences.

10:00 a.m. – 10:15 a.m. | Welcome and Opening Remarks
Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol-Myers Squibb

10:15 a.m. – 10:30 a.m. | What is Rapid Microbiological Methods and Why is it Important
Michael J. Miller, PhD, President, Microbiology Consultants, LLC

10:30 a.m. – 10:50 a.m. | Demonstrating Method Suitability for an ATP-bioluminescence Rapid Method for Egg-Based Vaccine Testing
Stacey N. Ramsey, MS, SM(NRCM), Associate Product Manager, Charles River Laboratories

10:50 a.m. – 11:10 a.m. | Evolution of an Automated Rapid Microbial Testing Technology to Satisfy Pharmaceutical Requirements
Lori L. Daane, PhD, Director of Scientific Affairs, bioMérieux, Inc.

11:10 a.m. – 11:30 p.m. | Validation and Global Implementation of an Alternative Sterility Test
Sven M. Deutschmann, PhD,
Head of Global Analytical Science & Technology "Adventitious Agents Testing & Alternative Microbiological Methods", Global QC, Roche Diagnostics GmbH

11:30 a.m. – 11:45 a.m. | Q&A

11:45 a.m. – 12:05 p.m. | Break

12:05 p.m. – 1:30 p.m. | P2: Expecting the Unexpected: Overcoming the Challenges of Rapid Testing
Moderator: Andrew D. Hopkins, BSc Hon PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie, Inc.

This session is a great opportunity to hear from both industry specialists (at the sharp end) and the regulators. Case studies will be used to show some of the challenges (and opportunities) that arise when introducing rapid micro methods. The first case study will discuss sampling and the use of rapid sterility tests, next we will have a presentation on the challenges of OOT and aberrant results when using rapid micro methods and then finally, we will be given an opportunity to hear firsthand some of the issues that the regulators see when companies introduce rapid technology. A great opportunity to learn from others and even perhaps even safe you having to deal with the same challenges if you are introducing rapid methods.

12:05 p.m. – 12:25 p.m. | STAT Results for STAT Samples: Implementing Modern Rapid Micro Methods
Wayne I. DeHaven, PhD,
Director, Pharmetric Lab

12:25 p.m. – 12:45 p.m. | Challenges Associated with Interpreting Aberrant/OOT Results Obtained from Rapid Microbiology Method for Detection of Mycoplasma Using Real-time Polymerase Chain Reaction for Release of Cell Therapy Products
D. Marissa Mistry,
Senior Scientist, Bristol-Myers Squibb

12:45 p.m. – 1:05 p.m. | An FDA Perspective on Rapid Micro Methods in the Pharmaceutical Industry
Bryan S. Riley, PhD, Branch Chief, CDER, U.S. FDA

1:05 p.m. – 1:30 p.m. | Q&A

Day 2

Friday, October 23

10:00 a.m. – 11:15 a.m. | P3: New Developments in Rapid Method Technologies
Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC.

Recent developments in rapid method scientific principles will be the focus of this session, as we explore new opportunities in miniaturization, automation and sensitivity. We will learn about a novel viability staining and Raman spectroscopy technique that provides quantitative and microbial identification results at the same time. Next, a miniaturized RT-PCR platform for the rapid detection of Mycoplasma will be discussed. Finally, we will hear about the development of a novel ATP bioluminescence system with single cell detection without the need for an enrichment step.

10:00 a.m. – 10:20 a.m. | Microbes as Analytes: Evaluating Raman Based Chemometrics for Quality Release
Kevin I. Wright, PhD,
Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble Techical Centres Ltd.

10:20 a.m. – 10:40 a.m. | Shaping the Future of Mycoplasma Testing – Evaluation of a New Automated and Rapid PCR-based Technology
Alex Z. van der Meer, MSc, Specialist Mycoplasma Testing, Janssen Biologicals

10:40 a.m. – 11:00 a.m. | Cultivation-free ATP RMM System and its Evaluation Based on Method Validation Criteria and Implementation in Pharmaceutical Water System
Yoko Nakaim, MS Engineering, Manager, HORIBA Advanced Techno, Co., Ltd.

11:00 a.m. – 11:15 a.m. | Q&A

11:15 a.m. – 11:35 a.m. | Break

11:35 a.m. – 12:45 p.m. | P4: Ask the Experts and Regulators
Moderator: Josh E. Eaton, MS, Assistant Director, Scientific Affairs, PDA

Industry experts and regulators join together to discuss applications and options for incorporating rapid microbiology methods across a variety of product classes. The panel will address some common issues regarding the technologies and their implementation and will also tackle attendee submitted questions. This is a prime opportunity to take advantage of their experience and perspectives to help guide your decision processes.

11:35 a.m. – 12:35 p.m. | Industry and Regulatory Round Table
Frederic B. Ayres, Research Scientist, Eli Lilly and Company
Michael N. Blackton, MBA, Vice President, Quality, Adaptimmune LLC
CDR James L. Kenney, DSc, Chief, LMIVTS, CBER, U.S. FDA
Bryan S. Riley, PhD, Branch Chief, CDER, U.S. FDA
Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble Techical Centres Ltd.

12:35 p.m. – 12:45 p.m. | Closing Remarks

Agenda is subject to change.

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