Understanding and Applying USP Chapter 621 for Generic Pharmaceutical Applications

USP Chapter <621> defines the adjustments that labs may make to their LC methods without having to revalidate. This webinar will cover the guidelines defined in <621> and provide practical examples of how to apply them, enabling scientists to confidently modernize their methods by improving speed and performance without the hassle of revalidation.

Key Learning Points

• Understand how <621> harmonizes multiple Pharmacopeia, including the European and United States, creating new allowable adjustments to monograph methods.
• Identify and apply technical details to Stationary Phase, Mobile Phase and Column Dimension allowable adjustments to improve method performance while maintaining compliance.
• Learn how practical examples of existing Monograph methods, and how utilizing these adjustments improves method performance. 

Who Should Attend

• Any laboratory managers, bench chemists, or QA/QC analysts who work with USP monographs in pharmaceutical and nutraceutical.

Speaker: Heiko Behr (Senior Business Development Manager, Phenomenex)