I'm a pharmacist graduated from National University of San Marcos (Peru) with a master's degree in Clinical Trials, Drug Studies & Medical Devices from University of Valencia (Spain) and master’s degree in Project Management from ESAN University (Peru), with a Black Belt Certification (Lean Six Sigma Institute) and ISO 9001:2015 Lead Auditor (TUV Rheinland).In recent years, my expertise has been focused on clinical trial since validation, initiation, monitoring and close-out visit, including regulatory activities with IEC/IRB and Regulatory Authority, training, support and advice to investigators on study-related matters. I have experience in quality assurance and regulatory affairs in consumer goods and pharmaceutical industry.I've worked as an audit, trainer and consultant on lean six sigma, quality management systems and continuos improvement projects and I have strong knowledge in GCP, GMP, ISO 9001, Project Management and Lean Six Sigma.