In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Discover how automation is revolutionizing laboratory processes, changes in the regulatory landscape, and how labs can stay ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

What does it mean when a course is ‘subject to validation’? All courses go through a rigorous approval stage by either our internal Academic Board or the relevant external degree-awarding body – this ...