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Nicole
Ferrari, President
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Nicole founded Global Validation with the intent to provide
customers with high quality validation solutions in the US and Eurpoe. Nicole is an American trained chemical engineer who
moved to Milan Italy and lives part time in both the US and Italy. Her connection to Europe provides North American pharmaceutical
companies the opportunity to have a highly trained engineer perform factory acceptance testing on equipment being purchased
from Europe. Nicole is also very skilled at providing training and knowledge transfer to all employee levels (operators,
engineers, maintenance technicians, supervisors). This service saves the pharmaceutical company time and money and allows
their valuable employees to continue working on site.
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Experience
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- FAT / PAT / IQ / OQ / PQ Testing for Sterile and Non-sterile Filling Machines for Solution
and Suspension Products.
Have specific experience with complicated filling machines with high quantity of changeovers
- FAT
/ PAT / IQ / OQ / PQ Testing for Autoclaves
Have extensive experience with complete autoclave validation including maximum
load design, bowie dick testing, steam quality testing, vacuum leak testing and all other testing necessary to bring the autoclave
into compliance with both FDA and European Regulatory Requirements.
- IQ / OQ / PQ for SIP Systems
Specializing
in design and validation of steam in place systems for tanks and filling equipment.
- IQ / OQ / PQ for Non-sterile
and Sterile Solution Tanks
- IQ / OQ / PQ for Packaging Equipment Including Labelers, Cartoners, and Check Weighers
- Process
Validation for Solutions and Suspensions
Specializing in pilot batch and scale up of new or re-formulated drug products.
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Positions Held
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- Engineering &
Contract Mfg. Manager
Bausch & Lomb, Inc. - Project Manager
Bausch & Lomb, Inc. - Process
Engineer
Bausch & Lomb, Inc. - Validation Engineer
Bausch & Lomb, Inc. - Bioscientist
Shriners
Hospital
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