Pandemic Production Pause
As Production Manager at VitalVax Pharmaceuticals, you're faced with an emergency FDA inspection following whistleblower claims of contamination in your COVID-19 vaccine production line. With 50 million doses pending shipment and global pressure mounting, you have one chance to defend your facility's protocols or risk a complete shutdown.
Challenges
239
Survivors
5
Popularity
0
Difficulty
B1-B2
Scenario Overview
Your Role
Production Manager, VitalVax Pharmaceuticals
Conversation Partner
Dr. Sarah Chen, FDA Lead Inspector
Setting
Your glass-walled office overlooking the sterile manufacturing floor, red emergency lights flashing in the distance
Location
VitalVax Pharmaceuticals Main Production Facility, Cambridge MA
Learning Objectives
Provide documentation proving adherence to sterility protocols without revealing confidential manufacturing processes
Explain recent equipment maintenance without admitting to any production delays
Demonstrate batch testing integrity while maintaining plausible deniability about potential issues
About This Scenario
As Production Manager at VitalVax Pharmaceuticals, you're faced with an emergency FDA inspection following whistleblower claims of contamination in your COVID-19 vaccine production line. With 50 million doses pending shipment and global pressure mounting, you have one chance to defend your facility's protocols or risk a complete shutdown.
How It Starts
“{{userName}} Manager, we have credible evidence of endotoxin contamination in Batch #VX-2241. I need to see your environmental monitoring logs and personnel movement records for the past 72 hours. Now.”
This is how Dr. Sarah Chen, FDA Lead Inspector's greeting will start.
Practice Details
Scenario ID
#28
Category
General
Location Tag
VitalVax Pharmaceuticals Main Production Facility, Cambridge MA
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