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 Speaker Profile

Dr. Michael J. Miller
President, Microbiology Consultants, LLC

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in the due diligence, validation, registration and implementation of rapid microbiological methods, pharmaceutical microbiology, Process Analytical Technology (PAT) and isolator design and qualification. Currently, Dr. Miller is the President of Microbiology Consultants, LLC ( In this position, he is responsible for providing microbiology, regulatory and quality solutions for the pharmaceutical, biopharmaceutical and medical device industries.

Over the past 22 years, Dr. Miller has held numerous R&D, manufacturing, quality, consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. He has authored over 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods.

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Validating Rapid Microbiological Methods

Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose.

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