30 mins

Change Control: Regulations and Guidelines

Computer System Validation – Application of the Validation Plan

ISO 14971 – The Scope of the Standard

The Use of Vaporized Hydrogen Peroxide (VHP) Chambers

Microbiological Testing Methods

Control of Microbiological Contamination in a GMP Environment

Microbiological Environmental Monitoring

21 CFR Part 211 Subpart H – Holding and Distribution

An Introduction to Endotoxin Control

Pharmaceutical Microbiology and Industry Considerations