Validation of Computer Systems

This course is designed for Validation, Quality, IT, and business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. Participants will gain a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. Attendees will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.