2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More
ISPE
SEPTEMBER 12, 2022
But what I am finding are some fundamental issues in the design phase where the people engaged in environmental monitoring are not part of the discussion. At least 90% of contamination (in data from industry surveys) comes from people as the direct source. Deputy Director, Office of Manufacturing Quality. Brooke Higgins.
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