Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

Since the 1980’s the FDA and International regulatory agencies have been very concerned about the increased use of computer systems for reporting, clinical trials analysis, and communication. Early validation guidance’s focused on processing and reporting. However, today the industry is dependent on the use of computer systems. Developments in areas such as Artificial Intelligence, computer-controlled processing, manufacturing, devices, and inventory systems require sophisticated computers, trained users, skilled IT professionals, and involved management.

This program provides both national and international requirements and the techniques needed to meet today’s challenging environment. Topics include FDA, GAMP, ISO, MDD, Risk analysis, and more.

This intensive, 12-hour accredited course is designed to provide an overview of the various aspects of computer validation including best practices, US and International regulations, and Industry expectations. It addresses the rules, tools and techniques to develop and provide the basis for compliance and implementation for a single system or a company-wide program and process.

The emphasis is on the most recent concepts and practices including risk assessment, vendor controls, electronic records and signatures, common problems, the Validation Project, Validation Planning, Validation Process, Testing and more. It will answer the key question: What is enough/When am I done?

Live attendees will have the opportunity to ask specific questions and participate in exercises as time allows. The course will review the most current compliance issues for the FDA. Additionally, live attendees will participate in a virtual computer validation case study.