Analytical Method Validation

precon

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Analytical Methods Validation

  • Background and Definitions
  • Review of Regulatory expectations
  • What role does IOPQ and system suitability play in validations?
  • What is the FDA looking for and what are common findings?

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

First Step in a Successful Validation is Method Development

  • Designing a development plan
  • Understanding the Intended purpose of the method and how that impacts development.
  • How to ensure that the developed method is validation ready
  • Setting predefined expectations

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Method Validation Attributes

  • What are the key attributes as defined by regulations/guidances
  • How to design the experiments for success
  • How to set acceptance criteria and how-to evaluation the data
  • Specificity
  • Precision
    • Repeatability, Intermediate precision and reproducibility
  • Linearity
  • Accuracy
  • Range

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Additional Validation Attributes Which May be Required

  • Purposeful Stressing
    • Forced degradation as part of specificity
    • Mass Balance
    • Degradation pathway
  • Robustness
  • Solution Stability
  • Sensitivity (LOD/LOQ).

 

register