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Berrin Onbas-Uzun
Ms. Onbas-Uzun received her Bachelor of Arts degree in Analytical Chemistry from Rutgers University in Newark, New Jersey. After 7 years of analytical research and development lab experience, she had moved into quality/regulatory compliance. She has over 20 years of scientific background that brings together clinical manufacturing and laboratory experience when driving quality improvement projects. Ms. Onbas-Uzun has an exceptional analytical and investigational ability for optimizing processes to achieve the maximum level of compliance in quality.
Ms. Onbas-Uzun is responsible for Clinilabs’ Quality Management activities that allow for effective planning and implementation of protocols, assurance of compliance with sponsor and regulatory requirements, identification of areas in need of improvement and corrective action, accuracy of data, and assuring a constant state of readiness for external audits, regulatory inspections, or monitoring visits. She joined the Clinilabs team in December 2010.
A Quality Management system includes both Quality Control (QC) and Quality Assurance (QA) functions. QC function is the real time, on-going (day-to-day) operational methods and activities undertaken to verify the requirements for quality related activities. QA function is the periodic, systematic, and objective review of trial-related activities undertaken to ensure that clinical trials are performed and the data are generated, documented, and reported in compliance with Good Clinical Practices (GCP) and protocol requirements.
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