This course is designed for Validation, Quality Assurance, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical industry. The course is of special value to personnel seeking experience with Computer Validation and issues associated with FDA regulated computer systems. The course is designed to provide a thorough understanding of computer system validation. In addition, the course will cover 21 CFR Part 11 (electronic record/electronic signature requirements), cGMP, OSHA, SAFETY and FDA regulations. The attendee 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.

Additionally this course requires 40 hours of internship / project.