Rapid Microbiological Methods: Regulatory Acceptance, Applications and Validation Strategies
This webinar will explore the implementation of rapid microbiological methods (RMM) within the pharmaceutical, biopharmaceutical and advanced therapy medicinal product (ATMP) industries. A review of FDA and EMA expectations for submissions and implementation will be discussed, followed by a review of applications I which RMMs can replace conventional microbiological methods. Next, an overview of validation strategies to demonstrate user requirements, regulatory expectations and pharmacopoeia recommendations have been met will be shared.
About the Presenter
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com)
For more than 30 years, he has held numerous R&D, manufacturing, quality and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. In his current role, Dr. Miller consults with multinational companies in providing technical, quality and regulatory support for rapid methods, sterile and non-sterile pharmaceutical manufacturing, ATMPs, contamination control and investigations, and GMP compliance.
Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University and a B.A. in Anthropology and Sociology from Hobart College. He has authored more than 100 technical publications and presentations and was the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and review boards for European Pharmaceutical Review, American Pharmaceutical Review and PDA Journal of Science and Technology. He is also the chairperson for the 2020 revision of PDA Technical Report #33.