Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices

This Method validation protocol training will discuss the regulatory requirements of analytical test methods, the USP good documentation practices <1029> and how to establish acceptance criteria for validation.

Why Should You Attend:

New medicines are developed every day to meet medical needs. Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality, and purity during its shelf-life. Therefore, validation is a critical process to assuring analytical procedures are documented for its intended use set forth by ICH, FDA, and USP.

This session will discuss the critical aspects of a method validation protocol according to the USP Good Documentation Practices General Chapter <1029> and to construct the analytical procedure required by the most recent FDA analytical validation guidance.