Points on planning and implementing experimental design for analytical method validation, and considerations for the procedure.
Points on planning and implementing experimental design for analytical method validation and examination procedures.
1. Purpose of Analytical Method Validation 2. Experimental Design for Analytical Method Validation 3. Implementation Methods for Analytical Method Validation 4. Key Points for Examining Linearity 5. Key Points for Examining DL/QL 6. Key Points for Examining Accuracy 7. Methods and Evaluation of Precision Calculation 8. General Precautions 9. Comparison of Old and New Quantitative Methods for AAA Preparations 10. Points to Note in Stability Testing 11. System Suitability in HPLC Methods 12. Considerations for Setting Standards 13. Quality Standards for Investigational Drugs 14. Technology Transfer 15. Outsourcing to External Testing Organizations 16. Quality System (ICH Q10) and Quality Risk Management (ICH Q9) 17. Risk Management & Compliance [Q&A and Business Card Exchange] *Requests for content in advance are also welcome!*
- Company：AndTech
- Price：Other
