Basic

ICH E8 Section 3 – Designing Quality into Clinical Studies

In-Process Sampling and Testing

Types of GMP Inspections (PAI, Routine, For Cause)

The Difference Between Audits and Inspections

ICH E8 Objectives, Fundamentals, and General Principles

GLP Records, Retention, and Disqualification

Plant and Clean Utilities for GMP Manufacturing

How to Act When an Inspector is On Site

Protocols, SOPs, and Quality Assurance Functions in GLP Environments

Laboratory Physical Hazard Identification