Event Detail
The Challenges of Monitoring Impurities in Pharmaceutical Products – The Requirements in Q3 A/B and Key Factors in Setting Impurity Specifications
February 4, 2010
- Live Webinar CANADA
BenAstrum
Discussion Points: * Learn of regulatory expectations through warning letters * Understand regulatory requirement guidelines surrounding impurities in API and Drug Products * Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products * Understand different thresholds to report and qualify new impurities * Key factors when setting acceptance criteria for impurities