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 ...

Six years after the guidance, it’s time to change our quality assurance vocabulary. In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its ...

Process Validation for Pharmaceutical and Biologics · GlobeNewswire Inc. Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to ...

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 ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

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 ...

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...

Today's injection mold manufacturers are much more than 'just moldmakers.' As OEMs - particularly those in the medical and automotive industries - become more and more dependent upon their supply ...

The future of validation is here! The State of Validation is the only annual research report dedicated to the validation industry. Join this webinar to dive deep into the findings with validation ...