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 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 ...

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality. Pharmaceutical Technology spoke with Archana M. Akalkotkar, PhD, research ...

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 ...

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

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 ...

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 ...

ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its Process Lifecycle Suite, part of the ValGenesis Smart GxP platform, at BioProcessing Summit Europe 2026 ...

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