Duke Clinical Research Institute
Director of Quality Assurance
Duke Clinical Research Institute
Director- Quality By Design
Duke Clinical Research Institute
Director-Quality Assurance and Regulatory Compliance- Interim at Duke Clinical Research Institute
D.m Charron & Associates Apr 2013 - Mar 2014
Independent Consultant-Owner
Duke Clinical Research Institute Apr 2013 - Mar 2014
Senior Regulatory Compliance Consultant
Education:
Thunderbird School of Global Management 1981 - 1982
Master of Business Administration, Masters, International Business
Ferris State University 1975 - 1977
Bachelors, Bachelor of Arts, Biology, Chemistry
Skills:
Fda Quality Assurance Validation 21 Cfr Part 11 Pharmaceutical Industry Gmp Quality System Clinical Trials Quality Auditing Gxp Process Improvement Business Process Improvement Sop Cro Biotechnology Quality Management U.s. Food and Drug Administration Training Regulatory Requirements Leadership Quality Control Pharmaceutics Computer System Validation Edc Clinical Research Change Control Clinical Development Clinical Data Management V&V Ctms Standard Operating Procedure Electronic Data Capture Gcp Regulatory Affairs Regulatory Submissions Cro Management Auditing Lims Change Management Drug Development Capa Sdlc Quality Systems
Jean-Jacques Bertrand High School Farnham Kuwait 1993-1997
Community:
Steve Gemme, Marc Flamez, Jonathan Pelletier, Janet Johnson, Patrick Rossum, Melanie Giroux, Mar Tin, Nathi Ngwenya, Mark Nunes, Mathieu Chartier, Cynthia Miller
Paris La DéfenseBusiness and Technical Manager at Kappa Conseil Past: Consultant Manager at Kappa Conseil, Responsavel de projeto - vida de série 207 para...