Dr. Michael J. Miller will be teaching his two-day rapid microbiological methods course immediately following the upcoming PDA Europe Conference on Pharmaceutical Microbiology (conference is Feb. 26-27; course is Feb. 28- March 1). This comprehensive course is designed to provide an introductory review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans. Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.
Additionally, Dr. Scott Sutton, The Microbiology Network and USP Expert Committee member, will provide an update to the newly revised USP chapter 1116, Microbiological Evaluation of Clean Rooms and Other Controlled Environments. An overview of some of the many sessions scheduled to be presented are listed below:
- RMM – An Alternative Method Validation with a New Light on Statistical Tools. Vincent Beguin, Merck Millipore
- The Response of Organisms to Stress and Injury: Exploring the Dynamics of Recovery using a Rapid Micro Method. Andrew Sage, Rapid Micro Biosystems
- RMM Issues from a Regulatory Perspective. Andrew Hopkins, MHRA
- Implementation of the MALDI Biotyper for Microbial Identifications in a QC Microbiology Laboratory. Amy McDaniel, Pfizer
- Application of Rapid Microbiology Techniques to Release a Virus Vaccine: A Case Study. Daniel Galbraith, BioOutsource
- Rapid Microbiological Methods (RMM) – A “Stunning” Advance in the Microbiological Field, but a “Slow” Implementation in the Pharma Industry. Fulvio Tavellini, Baxter
- Status of RMM Validation PDA Technical Report No. 33. Michael J. Miller, Microbiology Consultants, LLC
- Remediating Pharmaceutical Water System Biofilm – What To Do After It Gets Ahead of You. T.C. Soli, Soli Pharma Solutions
- Microbial Control Strategies in Bioprocessing Falling Short of Assuring Product Quality and Satisfying Regulatory Expectations. Anastasia Lolas, Visionary Pharma Consulting
For more information about the conference, please visit the PDA Europe website. For additional information about the two-day rapid methods course, please visit the RMM Course website.