Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

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 ...

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 ...

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 ...

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 ...

We used diabetic retinopathy (DR) as a case study to show application of the proposed biomarker development process. Loss or impairment of vision due to DR is one of the most profound complications of ...

FORT BELVOIR, Va. – The Command Service Office (CSO) within the U.S. Army Intelligence and Security Command (INSCOM) operates a rigorous review board as the centerpiece of its contract requirements ...

This paper provides practical recommendations for the validation of the backtesting process under the targeted review of internal models (TRIM). It advises on the introductory steps for validating the ...