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PDA Mourns FDA Micro Leader Vivian Greenman

May 30, 2017

PDA member and former US FDA microbiology reviewer Vivian Greenman passed away on April 18. She was 94 years old. In 1973, the FDA recruited her in response to a series of nosocomial infections caused by nonsterile large volume parenterals (LVP) that occurred in 1970 and 1971. Upon her arrival to FDA, she was the first microbiology reviewer in the CMC program. Her participation in the development of LVP standards was important to such regulatory work as the 1976 proposed rule on LVP CGMPs, sterile product container and closure integrity testing, and guidances on filing applications for sterile drugs, aseptic processing, and post-approval changes.

For many CMC review microbiologists at FDA, she was their primary mentor in developing their careers as pharmaceutical microbiologists. Vivian was well respected in the sterile pharmaceutical industry.

She retired from FDA in 2005 and returned to her home state of California to be with family.

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