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.
Company Details
- Employees
- 2
- Founded
- -
- Address
- פארק תעשיה ב, עומר,- 12345,israel
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- qaandvalidation-ludan.co.il
- Keywords
- Validation, Quality and Engineering consultants, Pharmaceuticals, Medical Device, Quality audits, Medical Cannabis, Combination Products.
- HQ
- עומר, -
Ludan Engineering- Qa And Validation Questions
Ludan Engineering- Qa And Validation's website is qaandvalidation-ludan.co.il
Ludan Engineering- Qa And Validation's LinkedIn profile is https://il.linkedin.com/company/ludan-qa-and-validation
Ludan Engineering- Qa And Validation has
2 employees.
View email and phone details for 2
employees at Ludan Engineering- Qa And Validation.
Ludan Engineering- Qa And Validation's industry is
Biotechnology Research
Ludan Engineering- Qa And Validation's top competitors are
Indian Immunologicals Limited,
Polygreen,
Ludan Engineering,
Kimberly-Clark,
Tree Of Life Pharma,
Ludan Engineering S.r.l.,
Omrix Biosurgery Israel,
Commissioning & Qualification Technology, Llc,
Tower Semiconductor,
Aspiro Pharma Limited.
Ludan Engineering- Qa And Validation's categories are Biotechnology Research
Ludan Engineering- Qa And Validation's founding year is 2005
