Abstract

Identifying and Understanding the Role of Qbd in Analytical Method Development and Validation

Dinesh Kumar, Associate Vice President, Alkem Laboratories Ltd

The talk will cover following specifics, 1. QbD current reality, 2. QbD framework for process versus Analytical methods, 3. ATP and CQA for Analytical methods, 4. Risk Assessment in AQbD 5. Design Space for Analytical methods 6. Why we need AQbD