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CASE STUDY 4: Aseptic Processing Controls | Imagine the perfect storm. This case study involves a manufacturer of medically necessary sterile drug products and combines numerous failures across various systems. Dive deep into deficiencies associated with media fills, sterility testing, environmental monitoring, aseptic line design, and data integrity and governance.
Moderator(s):
Brooke
Higgins,
Senior Policy Advisor for the Global Compliance Branch 3,
FDA/CDER