True/False
Only major QEIs should be notified to the PV CSR QE team
False, all QEIs require the team to be notified within 1 BD
How many business days from date of discovery should the QE team be notified of the event?
1 business day
What type of quality event has a low event risk?
Minor
Who performs manager review of quality events?
ASAM Oliver Wilson
What is considered a type of non-compliance or non-conformance to expected documented standards?
Quality Events
RCAs should be chosen from 1 category and 1 sub-category
True
How many business days from date of discovery does the QE have to be raised within the QE system?
3 business days
What type of quality event has a medium event risk?
Major
Who raises quality events in the QE system?
PV CSR QE team
What does RCA stand for?
Root Cause Analysis
Only major QEIs require an investigation, minors do not
True, only minor QEIs do not require an investigation or action items.
How many business days from date of discovery does the client have to be notified?
3 business days
What type of QE would be raised for missing internal timelines?
Minor
Who is the senior safety admin manager overseeing the PV CSR QE team?
Amy Davies
Do QEs have to be closed with a certain amount of calendar days or business days?
Calendar
Acronyms should always be spelled out the first time they are used
True, all acronyms should be spelled out when using them for the first time, ex. Pharmaceutical Product Development (PPD)
How many days does the QE have to be closed?
45 calendar days
What type of QE would be raised for a late submission to a RA or EC?
Major
What step does the QE go to once fully closed?
QEM
How many RCA categories does the CSRT follow currently?
BONUS POINTS if you can name all 5 RCA categories!
The QE team can write the information in any order and does not matter if it’s chronological.
False, the information must be written in chronological order.
How many days does the PV CSR QE team try to have QEs closed by?
30 calendar days
How many types of quality event types are there?
3 - minor, major, critical
How long does QA require to perform the final review?
4 business days
What is the SOP/GD for QEIs?
SOP-GQC-42 Quality Event Management, revision 02, 02-Nov-2020
TI-QEM-PVG1-10078 PVG Quality Event Management (QEM) Technical Instruction v07, 28-Oct-2022