Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date CBER's Perspective on Evaluation and Implementation of Rapid Microbial Methods CAPT Simleen Kaur, at FDA, Lori Daane at bioMérieux and Jon Kallay at Charles River Microbial Solutions Conventional microbiological methods are established and have been used for detection and identification of microbiological contamination in biologica... 4 weeks ago | 119 mins Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Mic... 3 years ago | 76 mins Rapid Microbiology Applications in the COVID-19 Era Dr. Michael J. Miller, Ulrich Herber and Lori Daane The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has... 3 years ago | 110 mins Update of the IFU Method No.12 for Alicyclobacillus spp Luis Costa, Field Marketing Manager LATAM, Millipore Sigma Important updates to the IFU Method No. 12 for Alicyclobacillus. Spore-forming Thermo-acidophilic spoilage bacteria are one of the major frequent conc... 3 years ago | 76 mins Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Mic... 4 years ago | 77 mins Regulatory Approval of Three Rapid Microbiological Methods for MACI Release John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles River Title:Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release Rapid detection of contaminants is essential for cell therap... 4 years ago | 65 mins Validation of Microbiological Methods – Expectations for Regulatory Compliance Dr. Rajesh K. Gupta Microbiological methods play a critical role in ensuring safety and efficacy of drugs and biologics. Most microbiological methods are described in com... 8 years ago | 70 mins Validation of Microbiological Methods - Expectations for Regulatory Compliance Dr. Rajesh K. Gupta Microbiological methods play a critical role in ensuring safety and efficacy of drugs and biologics. Most microbiological methods are described in com... 8 years ago | 70 mins Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and C Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products Gene and cell therapy products, also... 4 years ago | 75 mins Changing the Paradigm: Moving to In-Process Release Testing Presented by Scott Weiss, Johnson & Johnson and Lori Daane at bioMérieux Changing the paradigm – moving to in-process release testing is a presentation to explore the possibilities of the future. We will discuss limitation... 2 years ago | 77 mins
