A specific website where one can find 483 notifications, Warning Letters, and Consent Decrees
What is the FDA website?
100
The year Allergan agreed to plead guilty and pay 600 million to resolve allegations of off-label promotion of Botox®
What is 2010?
100
Figure 1
What is compendial example for determining chromatographic signal to noise?
100
Replacement and replenishment of lab consumables on the lab bench shelves.
What is a Monday Morning Lab Clean-up Responsibility?
100
An electronic achival system for PAM SOPs
What is Coral
200
The form number that the FDA uses to notify a firm of an inspection
What is a 482 form?
200
The unit responsible for the most cGMP 483 citations in 2012
What is the quality control unit (20%)?
200
Figure 2
Who is Martha Stewart?
200
Incomplete and/or ineligible writing on reagent containers and log book entries
What is an observation during the Monday Morning Lab Clean-ups?
200
SOP 31008
What is the Laboratory Notebook and Data Package Procedure?
300
Covers the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records
What is 21 CFR Part 11
300
Three items usually documented in insturment logbooks.
What are usage, equipment failures and maintenance?
300
Figure 3
What is Eiffel Tower?
300
Not following methods or protocols as written.
What is non-compliance with policies and procedures?
300
SOP 31010
What is the Hazardous Waste Disposal Procedure?
400
21 CFR 211.25 'Personnel Qualifications'
What is the regulation that governs education, training and experience requirements for an analyst?
400
Appropriate training, acuity, and maximum amount of time allowed.
What are the requirements for visual inspection?
400
Figure 5
What is Escherichia coli
400
Figure 6
What is a laboratory safety violation?
400
SOP 32010
What is the Evaluation and Disposition of OOS Results?
500
21 CFR 211.100
What is the regulation that requires written procedures and deviation justification?
500
A requirement for conducting a thorough investigation.
What is scientific justification?
500
Daily Double - Figure 4
What is green tea?
500
Not rinsing your glassware with an appropriate solvent or leaving a weight boat in a flask sent to be washed.
What is not adhering to SOP 32017?
500
SOP 32040
What is the PAM Novel API, Excipient, and Formulation Cleaning Assessment?