New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines 2019

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines 2019 is a webinar dedicated to the new elemental impurities test requirements as per new ICH Q3D and USP 232/233 Guidelines, how to do risk assesment.

Topics

• Regulatory status: FDA, ICH Q3D, USP 232/233
• Elemental Impurities: The case for change
• What drug products are within the scope of the guidance
• Scope of the new guidance on Elemental Impurities - related to ICH Q3D and USP Chapters 232 and 233
• How risk assessment influences what testing is required
• Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
• Implementation of the Guidelines
• What documentation related to control of elemental impurities is expected by FDA
• Analytical Procedures and how methods should be validated
• Which procedures can be used to demonstrate compliance
• What you should be doing now?

Who should Attend

Attendees from:

• Laboratory Managers/ Directors / Supervisors
• Researchers/ R&D Mangagers
• Analytical Chemists
• Laboratory Technicians / Operators
• Regulatory Compliance Managers
• Laboratory Managers
• Chemical Manufacturing and Control managers
• Quality Control and assurance managers