This course is a comprehensive overview of US Food and Drug Administration (FDA) 21 CFR Part 11 regulation to help understand and guide staff to the application of the rules.  The topics that will be cover the history leading up the issuance of the regulation, the scope of part 11, controls necessary to apply to electronic records and electronic signatures.  Lastly, we will cover a few examples of warning letters of other companies in the industry who failed to meet the requirements. 

This course is intended for Charles River employees who must comply with the CFR Part 11 regulation.