30 mins

Root Cause Analysis

ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2

ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2

The Lifecycle of a Change Control Program – Examples of Change Controls, Documents & Recording Completed Changes

Change Control: Regulations and Guidelines

ISO 14971 – The Scope of the Standard

21 CFR Part 211 Subpart H – Holding and Distribution

An Introduction to Endotoxin Control

Good Manufacturing Practices – Good Practices and Quality Control

Good Documentation Practices – Data Integrity for General Test Results