rapidmicromethods.comRapid Microbiological Methods

Rapid Micro Methods Scientific Principles _Introduction to RMMs _Growth-based Methods _Viability Staining and Laser Excitation _Detection of Cellular Components _Optical Spectroscopy _Nucleic Acid Amplification _MEMs Product Matrix Validation Strategies Regulatory Expectations _Overview _Annex 1 Revision _Rapid Sterility Testing of ATMPs _Changing Acceptance Levels _US Food and Drug Administration (FDA) _European Medicines Agency (EMA) _Rest of World Learn More Home Industry News RMM Blog Events References Calculate ROI Training & Consulting Contact Us Community (RMM) Welcome to the most comprehensive, educational online resource for alternative and rapid microbiological methods, regulatory policies, validation strategies, current trends, expert training and consulting, and opportunities for the advancement of public health initiatives. Fundamentals Scientific Principles 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. The Product Matrix 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. Validation Strategies 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. Regulatory Expectations 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. Return on Investment (ROI) 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. Need Help? We Provide Training and Consulting Services 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 and commercialization strategies for numerous industries. 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. Join our Rapid Microbiology LinkedIn Community 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. Featured Technologies Learn More Industry News Our news page will keep you informed of press releases and news articles on rapid and alternative microbiological method technologies and updates from technology suppliers. The Rapid Micro Blog Our blog will keep you informed of new and noteworthy technologies, reviews of recent publications and presentations, upcoming conferences and training events, and what’s changing in the rapid and alternative microbiological methods world. Events Here you will find in-person and virtual conferences, webinars and training courses focused on the advancement of alternative and rapid microbiological methods. References We provide an extensive list of references, publications, regulatory documents, white papers and pharmacopoeia communications relevant to the validation and implementation of alternative and rapid methods.rapidmicromethods.com is managed by Dr. Michael J. Miller, PhD, President, Microbiology Consultants, LLC. © Copyright 2010-2024 rapidmicromethods.com. All rights reserved. Microbiology Consultants, LLC Terms of Use Contact Us...