1) Method Development, Optimization and Validation Approaches
2) Method Validation – High Level
3) System Suitability
4) Validation Components
a) Accuracy
b) Precision
c) Repeatability
d) Interm. Prec.
e) Specificity
f) LOD
g) LOQ
h) Linearity
i) Range
5) LifeCycle Concept
6) Validation Planning
7) Method Validation Protocol
8) Method Transfer & Revalidation
9) European and International regulatory bodies and their guidelines on different aspects of Method Validation QA
10) Quality by Design
a) Lifecycle management of analytical procedures: development, validation and routine use
b) Using principles of Quality by Design to get most robust methods
c) Defining validation parameters, acceptance criteria and test procedures
d) Templates and examples for efficient and consistent documentations
11) How we know what FDA is looking for
a) FDA Systems Based Inspection: Laboratory System
b) FDA 483s
c) FDA Warning Letters