Modern microbiological laboratories should look toward developing innovative approaches to the detection, quantification and identification of microorganisms. Our tutorials explain the benefits of implementing rapid methods for a wide range of applications and sample matrices.
Our RMM Product Matrix allows you to compare multiple rapid microbiological method technologies that are commercially available or in development. This non-biased review describes the scientific method, workflow, time to result, throughput and sample considerations for qualitative, quantitative and identification technologies.
It is common industry practice and a regulatory expectation that alternative or rapid microbiological methods are adequately validated to demonstrate the technology is suitable for its intended use and equivalent or non-inferior to the existing method. We provide the framework for a robust validation plan.
To assist the industry in implementing rapid and alternative technologies, global regulatory authorities have implemented policy changes, developed guidance documents and discussed the acceptance of RMMs in publications and at worldwide conferences. This section provides a deep dive into current regulatory expectations when validating and implementing RMMs.
It is important to understand the upfront costs and potential long-term cost savings associated with the purchase, validation and implementation of an alternative or rapid method. We demystify the concept of ROI by providing clear and easy to understand concepts for an economic analysis.
Our principle expert, Dr. Michael J. Miller, has consulted with end-users on RMM selection, validation, regulatory submission and implementation. He has also worked with numerous RMM suppliers in developing technology, validation and commercialization strategies across relevant industry sectors. Dr. Miller is co-chairing the revision of PDA Technical Report No. 33, has served as an advisor to USP's Modern Microbiological Methods Expert Panel, and routinely speaks at pharmaceutical microbiology conferences around the world.
With more than 18,000 members, this LinkedIn group shares information about the advancement of alternative and rapid microbiology technologies and understanding regulatory and pharmacopeia guidance, validation expectations and implementation strategies.
