Machine and process troubleshooting are the most important factors in controlling process and reducing defects. Poorly performing presses lead to process variance and uncontrollable scrap events, 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 ...

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 ...

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 ...

As technology capabilities and customer requirements have evolved, so have gas turbine testing and validation methods. Mitsubishi Hitachi Power Systems believes the proof of its long-term validation ...

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 ...

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 ...

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 ...

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 ...

Purpose: Validation of fluorescence in situ hybridization assays is required before using them in clinical practice. Yet, there are few published examples that describe the validation process, leading ...