Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
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 ...
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 ...
Medical Care, Vol. 47, No. 12 (December 2009), pp. 1244-1250 (7 pages) Background: Health care process quality measures usually are designed by expert panels attempting to synthesize nuanced clinical ...
With the increasing adoption of COAs, the importance of standardization across training, collection, and implementation to ensure high quality and consistent data collection has become apparent in ...
The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the ...
The highly competitive thermoplastic industry is constantly expanding its capacities and developing new products. Additionally, resin manufacturers periodically institute formulation changes due to ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback