Method Development Strategies for Impurity Control in Late-Phase API Manufacturing

Learn how to navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing.

Register Free: https://www.chromatographyonline.com/lcgc_w/impurity

Event Overview:

To help navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing, this webcast will review the application of various laboratory techniques, including LC, LCMS, GC, and ICP-OES/MS, as well as other methodologies. Learn more about common method development and validation strategies and the pros and cons posed by analytical techniques used for impurity assessment.

Key Learning Objectives

• An understanding of the regulatory landscape for impurity control and late-phase APIs
• A review of the analytical technologies used for impurity assessment
• A look at method development and validation strategies

Who Should Attend

• Chemistry Manufacturing Control (CMC) and regulatory leaders
• Analytical scientists working in method development
• Scientists with an interest in the determination of API impurity control
• Scientists with an interest in HPLC or GC separations and mass spectrometry

Speakers:

Shankar Sankaran
Director of AMPAC Analytical

Shankar Sankaran is the Director of AMPAC Analytical, overseeing method development, validation, release testing, stability studies, and reference standard management for CDMO operations and standalone analytical services. Shankar has been with AMPAC for 15 years. Prior to taking over leadership of AMPAC Analytical, Shankar worked as a Laboratory Chemist, with increasing responsibilities in both Quality Control and Method Development organizations to support early to late phase and commercial API programs.

Register Free: https://www.chromatographyonline.com/lcgc_w/impurity