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Constantin Chantzis

Angestellt, Founder & President, TechnoBusiness Solutions
Stewartsville, Vereinigte Staaten

Fähigkeiten und Kenntnisse

Pharmaceutical Consultant
Regulatory Compliance Consultant
Pharmaceutical Quality Assurance Expert
Quality Control Consultant
Product Development Consultant
Due Diligence Audit
Investigation
Expert
Engineering
Consulting
Services
Validation Study Consultant
Specialist
Expertise in quality control
quality assurance and regulatory affairs
medical products businesses
chemistry
manufacturing and controls (CMC) section of drug m
DMFs
analytical methods and process plans
protocols and reports
form FDA 483 and warning letter responses
corrective and preventive action plans
training
general cGMP
general validation
and test method validation
negotiations with regulatory agencies
customers
distributors and internal group
data analysis including specification development
trend analysis
expiration and retest date justification
test method characterization and validation
site qualification processes
product design validation documentation
test method validation document evaluation
data traceability audits
manufacturing process validation master plans
new product development
planned discontinuance of out-dated products
NDA pre-approval inspections
corrective actions
responses and re-inspection
chemical manufacturing processes
good manufacturing practice (cGMP)
total quality management and ISO 9001 registration
in vitro diagnostic reagent
instrument design control and quality control. Exp
quality control
project management
regulatory affairs
product development
management
26 years experience in product development
process development
validation
large scale manufacturing facility validation and
production management
quality assurance
quality control of FDA licensed biotechnology
small molecule and device products
regulatory experience
GMP audit
regulato

Werdegang

Berufserfahrung von Constantin Chantzis

  • Bis heute 34 Jahre und 11 Monate, seit Juli 1990

    Founder & President

    TechnoBusiness Solutions

    Hands-on, practical and highly accomplished individual with industrial conference chairmanships, workshops, seminars plus micro and macro experience over the full life cycle of a product comprising ideation, concept/prototype development; business and technical feasibility; intellectual property due diligence and patenting; product design and development; process design and development; process scale-up and technology transfer, process start-up, optimization and validation; product launch, regulatory compli

Ausbildung von Constantin Chantzis

  • 1983 - 1985

    Business Administration

    Fairleigh Dickinson University

  • 1978 - 1980

    Chemical Engineering

    City University of New York City College

  • 1976 - 1978

    Chemical Engineering

    City University of New York City College

Sprachen

  • Englisch

    Fließend

  • Griechisch

    Fließend

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