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CW-SES108
Regulatory Expectations and Trends in Aseptic Processing: Review of Recent Findings
Case Study 1 - Unexpected Health Crisis | Case Study Topic 1: Dealing with the Unexpected Situation of a Health Breakout: An OAI (Official Action Indicator) company making medically necessary drugs during a pandemic
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…