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Frank Settineri




Frank Settineri has a B.S. and an M.S. in Microbiology from Rutgers Univsersity.  With 30 years of pharmaceutical manufacturing and business experience, he is an authority on GMP compliance, validation planning, outsourcing, and microbial and sterile and non-sterile manufacturing solutions.  Frank has qualified testing laboratories and finished product supplier sites through GMP audits.  He has investigated and rectified microbial contamination and sterility problems.  He is a Quality Assurance expert on laboratory and sterile and non-sterile manufacturing operations.  He has remediated businesses and brought them back on line.  

He has over 30 years of pharmaceutical manufacturing and business experience, is an authority on GMP compliance, deviations and investigations, root cause analysis, rectification of sterile and non-sterile microbiological data deviations, particulate matter, and outsourcing of suppliers, contract laboratories and manufacturing sites.  He is particularly adept at writing responses to 483s and warning letters that result in both interim controls and sustained cGMP compliance.  He is the principal of Veracorp LLC, whose clients include virtual start-ups, compounding pharmacies, API manufacturers, solid and liquid oral dosage manufacturers, sterile facilities, medical device operations and microbiology laboratories.  Veracorp LLC assembles teams of multidisciplinary experts and often leads its client’s  quality system remediation initiatives.

 

Employment History

November 2006 - Present  President and Founder, Veracorp, LLC.  VeraCorp helps pharmaceutical, biotech, medical device and cosmetic clients achieve compliance with regulatory requirements. Services include assistance in lifting warning letters, resolve 483 issues, and develop operational and human capital action plans to guarantee their continued compliance.


Chiron's New Jersey office with Novartis.

2000 - April 2006   Director, Chiron   Integrated merger between Chiron and Pathogenesis and between Chiron and Novartis. Created and moderated interdisciplinary teams to improve existing products and develop new products.

Member of American Management Association

Past President of (NJ) Metro PDA and Past National Chairman of FDA/PDA Annual PDA

Past Member of AAMI guidance committee

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