Analytical Method Validation

precon

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Designing Validations Based on Intended Purpose

  • Designing a phase appropriate method validation
    • Phase I/II vs Phase III/NDA
  • Understanding compendia methods
    • Validation vs Verification
  • Stability Indicating Assays
  • Understanding the differences between a quantitative test and a limits test
  • Specific Tests

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Validation Process

  • Establishing appropriate Validation SOPs
  • Drafting effective Validation protocols
  • Determining which Reference standards and samples should be used
  • How to set appropriate and effective Acceptance Criteria
  • Validation Report

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Analytical Method Transfer

  • Transfer Package
  • Different training approaches and their effectiveness
  • Transfer design considerations
  • Transfer acceptance criteria
  • Data evaluation
  • Common failures

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Lifecycle Support

  • Evaluating method impact when there are changes in drug substance synthesis or drug product manufacturing,
  • How to bridge the exit
  • Method updates
  • System Suitability

 

register