Webinar: QbD Approach to Analytical Method Lifecycle

Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Demonstrating that these methods consistently perform appropriately for their intended purpose can be both challenging and resource... More

Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Demonstrating that these methods consistently perform appropriately for their intended purpose can be both challenging and resource intensive. By using a pro-active, quality-by-design (QbD) approach, it is possible to design better methods, understand the strengths, weaknesses and capabilities of those method and to perform validation exercises in a scientifically rational way that will maximize success and minimize overall resource consumption. This is especially true for the method transfer process, where many examples of tremendous complication can be cited due to inadequacy in method design and development, and due to inappropriate design of method transfer protocols. This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods. By using a lifecycle approach, methods are more likely to meet their int Less