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 biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to ResearchAndMarkets.com's offering. This FDA Process Validation Training ...
DUBLIN, May 10, 2018 /PRNewswire/ -- The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets ...
The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...
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 ...
FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...
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