Inappropriate Dad Jokes (Cleaning)
NC Winter is a Joke (Asepsis)
TXA TXA TXA TXA (Misc)
Deviations are Bad (Documentation)
I don't know what to put for this category (Misc)
100

What is the molecular formula for Hydrogen Peroxide?

H2O2

100

List every location where personnel micro plating occurs. 

Top of the head, chest, fingertips and palm of both hands. (Both wrists and lower legs for gown certification, optional answer). 

100

Currently, what are the five primary cleanroom classifications at the Michelle Facility?

RNC, CNC, Class 100,000, Class 10,000, and Class 100.

100

What does CFR stand for?

Code of Federal Regulations

100

What website under the Exela Managed Bookmarks is used for reporting safety incidences and close calls?

Gensuite

200

How often do you sanitize your hands in a controlled environment? 

Every time you switch to a different task, touch something, document, change gloves.

200

What is the minimum amount of CFUs needed for an action level excursion when personnel monitoring in a Class 100 space?

One

200

What is the current date format we print on IV bags?

YEAR/MO

200

What does contemporaneously mean?

Performed concurrently, at or nearly at the same time. 

200

What does BMRAM stand for?

Blue Mountain Regulatory Asset Manager

300

What does CNC stand for?

Controlled Non-Classified. A room where air is filtered to reduce contaminants below normal environmental levels but isn't formally designated with a Class or Grade. 

300

What is the form used when transporting QC Micro samples to the lab from Michelle?

FORM-001023: QC Sample Transport Form (FRM-000832 Veeva)

300

What does HEPA Filter stand for?

High Efficiency Particulate Air Filter.

300

What are the four acceptable error codes allowed for error corrections?

CE - Calculation Error

TE - Transcription Error

SE - Spelling Error

DE - Date Error

300

How often are media fills required for a person to maintain aseptic qualification?

Once a year

400

What is the Veeva document number for the Cleaning and Sanitization of Manufacturing Cleanrooms SOP?

SOP-000006

400

If a gowning certification lapses for less than 30 days, what must occur to re-certify?

Gowning certification must occur with only one testing occasion instead of three.

400

Where are the two main places you can go to search for SDS sheets?

The internet and the SDS bookmark under the company managed bookmarks tab. 

400

When may red ink be used when documenting on GMP documents?

When grading quizzes or redlining a document for changes. 

400

What does SAP stand for?

Systems, Applications, and Products. 

500

How does a sporicidal agent vary from a disinfectant?

A disinfectant kills microorganisms whereas a sporicidal agent destroys nonliving spores formed by microorganisms. 

500

What is a pyrogen?

Any substance that is able to cause a fever upon entering the blood.

500

Name at least 15 departments in Exela. 

Examples:

QA - Batch Review

QA - Operations

QC - Chemistry

QC - Microbiology

R&D

Tech Services

Operations - P&L

Operations - Inspection

Operations - Fill

Technical Writers

Facilities

Maintenance

Engineering - Process/Automation

Metrology

Operations Excellence

Materials Management

IRMI

Project Management

Sales

Finance

Procurement

Security

500

List at least 8 sections in a typical Exela Batch Record. 

Examples:

Product Information

BOM

Dispensing

Compounding

In-Process Testing

Bulk Solution Sterile Filtration

Filling

Terminal Sterilization

FDP Sampling

Inspection

AQL

500

How long does Exela retain manufacturing records?

8 Years

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