Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements 2015

Topics

• Discuss warning letters and citations
• Understand regulatory expectations
• Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products
• Understand regulatory requirement guidelines surrounding impurities in API and Drug Products
• Understand different thresholds to report for regulatory submission

Who should Attend

• QA and QC Managers
• R&D analysts
• Directors
• Regulatory scientists
• Regulators and Researchers who are responsible for providing analytical data pertaining to pharmaceutical products