Validation Agents
Pharmaceuticals - Otsego, Minnesota, United States
Validation Agents Employees
Validation Agents Details
We have a passion for bringing user's perspective, compliance and common-sense into design and manufacturing of automated systems and manufacturing processes. Utilizing all available resources to make better products and provide excellent services. Our expertise is in manufacturing, validation and project management of pharmaceutical equipment & systems.We provide cGMP competence and consultancy together with years of experience in aseptic machinery industry. In-depth knowledge of the US and EU regulations. Strong record of CQV project management under ISO 14644, ICH, ASTM e2500, CFR 21-Part 11, GAMP5, ISO9001, PDA, ISPE and PIC/S norms. Hands-on experience from 29 different pharmaceutical facilities worldwide. SME on fully automated production lines, washing machines, depyrogentation tunnels, aseptic fillers, capping machines, tray loaders, secondary packaging systems, inspection technology, LF hoods, RABS, VHP isolators.We are known for flexibility, integrity and excellence in project management and customer service.
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