PDA Microbial Data Deviation Investigations Conference

Microbiological data deviations occur when microbial test results do not meet the specified criteria in a drug application or other regulatory standards. The term "microbial data deviation" is preferred over "out-of-specification" or "out-of-limit result" because these tests are typically in-process rather than finished-product tests. Regulatory authorities pay close attention to this area during inspections. Attend the PDA Microbial Data Deviation Investigations Workshop to learn more and gain insights from real-world examples. The workshop will include a recap of the newly developed PDA Technical Report No. 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (TR88). The event will begin with welcome remarks from Workshop Co-Chairs Marc Glogovsky and Christopher A. Murdock, followed by a case study presented by Chris Knutsen.