15 mins

In-Process Sampling and Testing

ICH E8 Objectives, Fundamentals, and General Principles

GLP Records, Retention, and Disqualification

Plant and Clean Utilities for GMP Manufacturing

GVP Signal Management

GVP PSUR (Periodic Safety Update Reports)

Quality and Pharmacovigilance Systems

Laboratory Physical Hazard Identification

Customer Complaint Handling

Computer Software Assurance (CSA)