Dublin, Jan. 13, 2023 (GLOBE NEWSWIRE) -- The "Latest Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation)" 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 ...

General Considerations for Process Validation - Stage 3 Continued Process Verification. A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance.

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, ...

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 ...

The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, ...

While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models.

Girindus has won its second process validation contract this year. The process is for the manufacture of an oligonucleotide currently in Phase III testing. It has been granted orphan drug status ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis ...

Vivos Inc. (OTCQB: RDGL) Vivos Inc filed a provisional patent No.: 63/873,014 - STERILE THERMOGELS Vivos Inc. is pleased to ...