Favorite Phrases
PQS requirements
Guess the SQA
Milestones
Root Cause Categories
100

Most asked question during triage

Do we need an event if there is no impact?

100
Notification or market action for a batch/lot approved and distributed.

What is a notification to management?

100

Transferred from Pfizer Rouses Point, NY to Sanford in 2015

Who is Michelle Arquiett?

100

Within 1 business day of awareness date (date of discovery)

When does the deviation need to be initiated in eQMS?

100

The departure is due to an error made by a human 

What is human?

200

Impact and Root Cause determined within 3 business days of the awareness date. 

What is day 3? 

200

The root cause is due to an issue with Equipment/Facility/Utility that is not caused by a human error. 

What is Equipment? 

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