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.
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines 2019 covers topics such as:
- 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?
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines 2019 intended for 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