QA folks
This QA mastermind spent the night on a bench in Vienna.
Who is Kevin O'Brien?
This 3-letter monster shows up every time a process isn't followed - and no one ever wants to own it
This FDA form is scarier than your student loan bill
What is an FDA 483 form?
This Disney movie could also describe batch records - it never let's go.
What is frozen?
The #1 rule of documentation: "if it's not written down..."
What is "...it didn't happen?"
Your in-house Calibration genius is not from Louisiana, but her favorite horse is named after this marshy wetland
What is a bayou?
What is an SOP?
This number one rule during an audit - never do this, even if you are nervous.
What is a lie?
What is a signature?
Auditors love when you live by this mantra - records should always be ready for review.
Who is Brittany Brown?
What is GDP
Auditors love to say this phrase right before your heart rate spikes.
What is "Show me the documentation?"
In the game of thrones terms, QA is basically the "night's watch." Their job is this.
What is "to protect the product at all costs?"
This five-letter acronym sums up good documentation practices: attributable, legible, contemporaneous, original and accurate
What is ALCOA?
This young man has experienced many near misses, in the form of general kidnapping and abduction.
Who is matt?
What is traceability Matrix
You're not ready for the audit until you've practiced this type of Q & A roleplay.
What is a mock audit?
QA's version of "the bachelor" - handing out roses is this.
What is QA approval?
What is ".......It didn't happen?"
Who is Courtney?
This part of CFR deals with electronic signatures and record.
What is 21 CFR Part 11?
The one thing auditors hate more than missing records/documentation
What is backdating records?
This popular Netflix show could be the title of every FDA inspection story
What is Stranger things?