This Laboratory compliance training will help to understand and implement the new USP chapter.
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.
For easy implementation, Attendees will receive:
- SOP: Auditing of Suppliers
- Master Plan: Template and Examples - Residual Solvents Analysis According to USP <467>
- Checklist: Implementing USP <467> Residual Solvent Analysis
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
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
Instructor Profile:
Ludwig Huber, is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. He is also the author of the Macro & Spreadsheet Quality Package from Labcompliance. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .
