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) Good Manufacturing Practice(s)

GXP(s) This acronym includes GCPs, GLPs, and GMPs

HCT/Ps Human Cells, Tissues, and Cellular and Tissue-based Products

HPCL High Performance Liquid Chromatography

HPV Vaporized Hydrogen Peroxide

HR Human Resources

ICH International Conference on Harmonisation

IND Investigational New Drug

IQ Installation Qualification

IRB Institutional Review Board

ISO International Organization of Standardization

ISPE International Society for Pharmaceutical Engineering

ITP Individual Training Plan

JITT Just-in-Time Training

JSA Job Safety Analysis

KTA(s) Knowledge Transfer Assessment(s)

LMS Learning Management System

LOTO Lockout/Tagout

MedDRA Medical Dictionary for Regulatory Activities

MSDS Material Safety Data Sheet

NDA New Drug Application

NEO New Employee Orientation

NoE Notice of Event

OJT On-the-Job Training

OOS Out-of-Specification

OSHA Occupational Safety and Health Administration

OQ Operational Qualification

PCA Peanut Corporation of America

PDP Planned Deviation Protocol

PPE Personal Protective Equipment

PQ Performance Qualification

PQC Product Quality Complaint

PQLI Product Quality Life-cycle Implementation

QA Quality Assurance

QC Quality Control

QMS Quality Management System

RCA Root Cause Analysis

RCT(s) Randomized Clinical Trial(s)

R&D Research and Development

ROI Return on Investment

SAE Serious Adverse Event

SDA(s) Skill Demonstration Assessment(s)

SISPQ Safety, Identity, Strength, Purity, Quality

SME(s) Subject Matter Expert(s)

SOJT Structured On-the-Job Training

SOP Standard Operating Procedure

TTT Train-the-Trainer

UAE Unexpected Adverse Event