11:00 AM - 04:00 PM
Day 1

Lecture 1:
– “GxP” Systems
– Computer System Validation (CSV)
– CSV Maintenance

Lecture 2:
– “GxP” Documentation Principles
– Policies and Procedures

Lecture 3:
– 21 CFR Part 11 Overview
– 21 CFR Part 11 Compliance
– FDA Regulatory Compliance

11:00 AM - 04:00 PM
Day 2

Lecture 4:
– Computers and Data Integrity
– Regulatory Influences
– Industry Best Practices

Lecture 5:
– Clinical Trial Master File (TMF)
– Electronic Trial Master File (eTMF)
– Trial Master File Content
– Before the Clinical Trial Begins
– During the Clinical Trial
– After the Clinical Trial

Lecture 6:
– Prepare for a Computer System Audit