131 - Validation of Analytical Methods (S9E11)

Delve into the intricacies of the analytical methods validation process, spanning from initial design to rigorous execution. Hear why such methods are so key and are used to not only make sure of good outcomes, but to protect those under your care. Emphasize key validation parameters such as specificity and accuracy, precision, LOD and LOQ, robustness, and system suitability. Break down a number of the processes so that you can become more familiar with their use and implementation.The analysis highlights the role and importance of following the standards and regulations set forth by ICH and the FDA. Examine case studies, and look at areas and processes to give an example of where validation plays a part in the entire process. Hear of some of the steps taken in testing in the real world, all in an effort to protect the most vulnerable people and ensure their safety every step of the way.