CBER reviewer and standards expert Seth Schulte gave a presentation on the evaluation and implementation of rapid microbial methods (RMMs) at the May 2024 FDA Regulatory Education (REdI) annual conference. He discussed: ● the RMM regulatory space ● RMM validation ● relevant compendial coverage and agency guidance, and ● common deficiencies observed with the development of RMMs. Companies that are deploying RMMs in product/process development or considering changing to them will find Schulte’s insights highly valuable.
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