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LAB 3: Analytical Method Validation
Description: Analytical test method validation is a fundamental GLP requirement both for product registration and GMP inspection of laboratories. GMP auditing trends worldwide are now focussing on Good Laboratory Practices, and in particular, analytical method validation.
This module is designed to provide participants with techniques and procedures for the validation, analysis and control of analytical test methods. The presentation covers such topics as definitions of performance parameters and their acceptance criteria and how to set up for cost efficient accuracy, precision and linearity studies, etc. The industry requirements for documenting method validations (ICH, TGA, and FDA) will be presented, as well as tips and techniques for method transfer.
Price: $239 (AUD)
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(Australian customers, please add GST.)
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Terms and conditions
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COURSE OUTLINE
INTRODUCTION
1. Welcome
2. Overview
3. Assessment
STANDARDS
4. Introduction
5. Analytical method users
6. Summary of lab standards
7. Industry standards
8. ICH standards
9. Pharmacopoeial methods
10. Review
METHOD VALIDATION OVERVIEW
11. Introduction
12. Definition of validation
13. Pre-requisites for method validation
14. Different uses for analytical methods
15. Performance parameters for assay validation
16. Protocol structure
METHOD PARAMETERS
17. Introduction
18. Performance parameters
19. Precision repeatability
20. Intermediate precision
21. Method accuracy
22. Method capability
23. Method specificity
24. Linearity and range
25. Sensitivity, LOD and LOQ I
26. Sensitivity, LOD and LOQ II
27. Sensitivity, LOD and LOQ III
28. Ruggedness/robustness
29. SST
30. Review
METHOD TRANSFER
31. Method transfer verification
32. Requirements
33. Review
STABILITY INDICATING ASSAYS
34. Requirements
CONCLUSION
35. Summary
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COURSE OBJECTIVES
Students completing this course should be able to:
- List the key method performance parameters used in validation
- Describe and calculate precision and accuracy
- Describe and calculate selectivity and sensitivity
- Describe and calculate linearity and range
- Describe and calculate robustness and system suitability
- State the documentation required to support method transfer
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SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
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