This course is designed to introduce technicians and professionals to the principles and regulatory requirements for validation documentation in the drug, biologic, and medical device industries. We'll delve into FDA process validation per 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices." Multiple activities nested within the presentation gauge knowledge and group breakouts gauge more application of newly acquired knowledge. The hands-on group breakouts center around a fictitious common pharmaceutical scenario: Process Validation of a Sterilization Process (autoclave).