This Laboratory compliance training will help to understand and implement the new USP chapter.
Why Should You Attend:
On July 1, 2008, the USP released a new major revision of its general chapter < 467>: now entitled Residual Solvent Analysis. Using the risk based approach solvents have been broken down in three classes with different requirements for maximum limits. Over the last few years there were lots of discussions during the development of the chapter, and still today the industry is unsure on how to implement it. This seminar will help to understand and implement the new chapter.Areas Covered in the seminar:
- History of requirements for Residual Solvent analysis.
- FDA, ICH and European General Requirements for Residual Solvents.
- Detailed USP < 467>requirements: changes to previous version.
- Classification of solvents: Class 1, 2 and 3.
- Determination of residual solvent limits for three classes.
- Analytical procedures A, B and C - Methodology and Validation requirements.
- Quantitative tests vs. limit tests: when to apply which with decision tree.
- Using alternative methods: when and how.
- FDA expectations: Going through the Industry and Office of Generics Guidance.
- How to best leverage test results and other information provided by suppliers.
- Recommendations for implementations.
Who Will Benefit:
- Pharmaceutical development and manufacturing
- Manufacturers or raw material and ingredients
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs
- Human resources (HR) managers and staff
- Documentation department
- Consultants
Course Provider
Dr. Ludwig Huber,
