Ludan Engineering- QA and Validation

QA and Validation Department is part of Ludan Engineering Israel, the department was founded as sperate department by Dr. Moti Izhar, in 2005. Ludan provides services in Quality Assurance, GMP and Validation (DQ, IQ, OQ and PQ) for facilities and equipment as part of engineering projects in the API industry since 1993. Main services that the department provides: GMP Consultant – QA Issues such as- Establishing company quality Policy Policy and working procedures writing Submission Facility file for health authority approval and support during inspections (FDA, MOH, EU) Contract manufacturing and analysis support Suppliers Audits Training, etc. GMP Consultant – Construction and Validation Issues such as- USER Requirements establishment Validation Master Plan for process and equipment (VMP, PVMP) Clean rooms design, construction & qualification Engineering Files preparation Equipment and Systems Validation: (Water, HVAC, cleaning validation etc.) We have extensive experience with startup’s and small company's long term support and Support for large company in projects and prior inspection.