ACTIVITIES WITH CLIENTS
A phase III pharma company
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Supporting qualifications of new facility: Clean rooms, HVAC, WFI system, Autoclave, filling line, washing machine, facility BMS. Writing protocols, review and approval of protocols and qualification reports.
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Writing quality and engineering policies and SOP’s
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Writing maintenance instructions
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Implementation of QMS system (DOT Compliance)
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Managing the process of locating a CMO for Fill & Finish of syringes.
A big pharma company
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Technical support for sterile homogenizers and compounding tanks
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Process design for complex sterile products
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Seminar on the topic of sterile homogenization
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A phase III pharma company
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Support issues in filling of Oxygen sensitive product
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Technical and scientific support for the freezing of a product filled in vials.
A big pharma company
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Upgrade of filling machine including a RBAS and a change from piston to peristaltic pumps
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Assessment of a filling room and ways for upgrade
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Performing process robustness assessment for two filling suites
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Support in filling room renovation
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A phase III pharma company
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Support the purchasing of powder filling machine (machine was ordered): Writing the URS, point of contact with vendors, technical and commercial evaluation of the proposals, comparison and selection of vendor.
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Assessment of environmental monitoring requirements and selection of system for the purpose
A big pharma company
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Building a unique stoppers feeder for a filling machine
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A big machine producer for the microelectronic and pharma companies.
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Perform an assessment for the materials and construction of an inspection unit for grade ‘A” environment
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An early stage start-up company
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Introduction to isolators and VHP sterilization
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Improvement of VHP cycle
Shamir Optical
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Assessment and writing the final report of damage to machines and facility as a result of a fire.
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Cosmetics Company
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Support in preparing the company for FDA inspection
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Improvements in new maintenance module
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Implementation of the QMS in a pharma company
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Dot Compliance – Quality Management Systems
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Technical and knowhow support for the manufacturing of equipment for sterile facilities.
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