ACRONYMS
GMP
What is Good Manufacturing Practices?
Creates and maintains GMP drawings
Who is Nate Keavney?
Environment where manufacturing or storage of product is taking place
What is GMP Space?
Process used to manage disruptions
What is DPF/CEN?
Equipment Control, Identification and Records
What is SOP-0040?
FDA
What is Food and Drug Administration?
Communicates to Clinical Lab Change Control Board
Who is Laura Pickrell?
Quality Management Software
What is Agile?
Quality Management Software
What is MediaLab?
Change Control Process
What is SOP-0048?
CAP
What is the College of American Pathologists?
Initiates GMP Change Control Drawings
Who is the Validation Engineer?
Provides formal handoff before validation begins
Who is Facilities?
CLIA started
When was 1988?
Equipment Calibration and Maintenance
What is SOP-0144?
EQMS
What is Enterprise Quality Management Software?
Approves Changes
What is the Change Control Board (CCB)?
Not expected to have a direct impact on product quality
What is Indirect Impact System?
Helps laboratories maintain accuracy of test results
What is CAP Laboratory Accreditation?
Facilities Regulatory Policy
What is POL-QS-1002?
CLIA
What is the Clinical Laboratory Improvement Amendments?
Determines Classification of Space
What is Regulatory?
Air compressor tanks are considered this type of system
What is No Impact Systems?
Initiates GMP Change Control Drawings
Who is the validation engineer?
Facility Qualification
What is SOP-0239?