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José Cotto, Associate Consultant, PhoenixSM
representative in the Caribbean and Latin America, has over
thirty (30) years of value-added experience providing
consulting and training on FDA, USDA and local regulations to industry.
His expertise also includes developing and implementing
quality systems, auditing for regulatory compliance, risk management/vulnerability
assessment and supporting validation and technical
service areas—with extensive experience in analytical systems (microbiology,
chemistry) and CGMP issues in chemical plants, pharmaceuticals,
medical devices, food/beverage and healthcare providers.
He instructs human resources staff in the implementation
of corporate guidelines to maximize their level of efficiency while producing
a high quality product that will meet all organizational
standards and regulatory requirements. He has successful project management
experience working with companies under severe regulatory
enforcement actions such as warning letters and consent decrees.
Mr. Cotto is an expert in the import/export regulatory requirements
for Caribbean and Latin America countries as well as the
USFDA's requirements for food, devices and pharmaceuticals
processing. He is also a certified HACCP assessor/instructor and risk
management/vulnerability assessor. Mr. Cotto has a B.S. in Biology and
is fluent in both Spanish and English.
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