Event
Introduction to USP General Chapter <467> Residual Solvents
topics: Residual Solvents/ class
Significant revisions to standards for residual solvents found in USP─NF General Chapter <467> became official on July 1, 2008. These changes continue to impact the industry. In this half day course, both compendial and regulatory aspects will be covered. Additionally, different options and control strategies for implementation of analytical procedures A, B and C will be discussed. Other related topics including Validation and, Verification of residual solvent testing as outlined in the new proposed general chapter <1467>.
Upon completion of this course, you will be able to:
- Understand the historical approach and guideline contained in Chapter <467>
- Apply a risk-based strategy concept when dealing with compliance issues
- Illustrate Options 1 and 2, as well as Procedures A, B, and C
- Apply regulatory aspects, validation and verification and alternative procedures
- Describe recent PF proposal for <1467>
Who Should Participate?:
- QC/QA
- Compliance staff
- Laboratory scientists
- Managers in the pharmaceutical and allied industries
- Regulatory professionals