Pharmaceuticals 2011 - Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements

Why Should You Attend :

Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality and purity during its shelf-life. The majority of analytical methods used in pharmaceutical development are HPLC analyses. cGMPs require validated stability indicating methods used to monitor the drug product’s stability profiles.

This interactive 4 hrs long course will examine validation parameters for HPLC methods used in pharmaceutical laboratories based on cGMP regulations and ICH guidelines. It will discuss proved forced degradation strategies to develop stability-indicating analytical procedures. Learn effective way to write validation protocol and determine acceptance criteria for validation, make documentation more manageable. This course will provide a practical and systematic approach to validate analytical procedures.