Ludan Engineering- QA and Validation
Biotechnology - Omer, South District, Israel
Ludan Engineering- QA and Validation Employees
Ludan Engineering- QA and Validation Details
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 writingSubmission Facility file for health authority approval and support during inspections (FDA, MOH, EU)Contract manufacturing and analysis supportSuppliers AuditsTraining, etc.GMP Consultant – Construction and Validation Issues such as-USER Requirements establishmentValidation Master Plan for process and equipment (VMP, PVMP)Clean rooms design, construction & qualification Engineering Files preparationEquipment and Systems Validation: (Water, HVAC, cleaning validation etc.)We have extensive experience with startup's and small company's long term supportand Support for large company in projects and prior inspection.
Ludan Engineering- QA and Validation Technologies
Frameworks and Programming Languages
ASP.NET
Load Balancers
Microsoft-IIS
Hosting
Amazon AWS