Location

Productivity and Quality Institute - Alexandria

Objectives

• The purpose of the CPV course is to educate the participant in • the regulatory requirements for the FDA CPV• put CPV into action• write cpv protocol

Outcomes

By the ending of this course participant will be able to:• Using and applying CPPs and CQAs in verification process • USING PROCESS SIGNALS DURING ROUTINE MONITORING

Course Contents

• STATUATORY AND REGULATORY REQUIREMENTS• FDA WORNING LETTERS INDICATE LAKE OF CPV• UNDERSTANDING PROCESS VARIABILITY• Identification of CPPs and CQAs for Continued Process Verification:• PROCESS VALIDATION AND DRUG QUALITY• PROCESS VALIDATION LIFE CYCLE• USING PROCESS SIGNALS DURING ROUTINE MONITORING• APPROACH TO PROCESS VALIDATION