Labs
How many testing laboratories are in the US?
2
What are the 4 pillars of Quality Culture?
Keep it Simple
Take Pride in Doing it Right
Ensure a Speak-up Culture
Own and Demonstrate your commitment to Quality
What does PMF stand for?
Plasma Master File
What is the PQAG score goal for plasma center RAR?
40
True or false: Validation works directly with DD&T to make DIS enhancements
True
Where are the testing labs located?
Covington, GA & Hoover, AL
How many districts are there currently?
17
What do viral markers (positive donations) impact for EU?
Plasma Master File (PMF) status
True or false: The PQAG team also audits suppliers and 3rd party plasma centers.
True
What does LNS stand for?
Lookback Notification System
What does PQR stand for?
Plasma Quality Release
Name the Region Quality Leads
Taylor DeVine, Rob Fredrickson & Janelle Spiegelhalter
In how many European countries do we have plasma centers?
3
How many inspections were conducted in FY2022?
327
What does BECS stand for?
Blood Establishment Computer System
Where does teardown take place?
LA & Covington
Name the 200th center
West Springfield or Pearland
What is the minimum holding period for plasma to be released to Vienna?
45 or 60 days
What percentage of inspections resulted in no findings for FY2022?
80%
What are our BECS systems?
DIS & LNS
For what Viral Markers does the lab test?
HCV
HBV
HIV
STS
Parvo
What does PPTA stand for?
Plasma Protein Therapeutics Association
How many European Plasma centers does BioLife have?
33
Who are the compliance leads for FDA and EMA?
FDA: Jesse Knoedler
EMA: Andrea Olson
Name all of the departments that make up Quality Systems
DDC, CM Lab, Validation, Quality Systems, Lookback