Computer System Validation: Regulatory Overview

The ever-increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer-controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers, trained users, skilled IT professionals, and involved management. This 90-minute accredited course is designed to provide an introduction and overview of key topics, regulations, tools, guidance, and foundational principles that guide computer system validation. Topics include: FDA, GAMP, MHRA, ISO, and MDD.