2020 PDA Rapid Microbiological Methods Workshop

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

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