List of abbreviations

ADDIE Analyze, Design, Develop, Implement, Evaluate

AE Adverse Event

ANOVA Analysis of Variance

API Active Pharmaceutical Ingredient

CAPA Corrective Action and Preventive Action

CEO Company Executive Officer

CFE Certified Fellow Employee

CFR Code of Federal Regulations

cGMP(s) Current Good Manufacturing Practice(s)

CLIA Clinical Laboratory Improvement Amendment

CPR Cardiopulmonary Resuscitation

CQU Quality Complaint Unit

DEG Diethylene Glycol

DIL Dear Investigator Letter

EDMS Electronic Document Management System

EM Environmental Monitoring

ESI Equipment-Specific Instructions

FDA (US) Food and Drug Administration

FIR Final Investigation Report

GCP(s) Good Clinical Practice(s)

GLP(s) Good Laboratory Practice(s)

GMP(s) ...

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