My company - QA INSIGHT Ltd. - was established to provide independent Good Clinical Practice (GCP), ISO 14155 and ISO 13485 consultancy and wide range of auditing services (clinical sites audits, vendor audits, clinical departments system audits, laboratories audits, etc).The company is located in Israel and provides its services worldwideWith clinical background, and M.Sc. in Quality Assurance and Reliability, I have over 20 years of experience in pharmaceutical, medical devices and in-vitro diagnostic industry – marketing, Clinical Quality Assurance (phase II – IV), and management of Quality Systems compliant with ISO 9001:2008 and ISO 13485:2003.I served as Quality Assurance and Clinical Quality Manager in International and Local pharmaceutical, medical devices and in-vitro diagnostic companies in areas of: cardiology, urology, immunology, oncology, metabolic and infection diseases.During my work I set up, implemented and maintained ISO (9001 and 13485) compliant Quality System, GCP compliant system; and performed vast range of 1st, 2nd party and 3rd party audits and Clinical Trials Audits. I lecture at the professional and educational forums on Quality Assurance principles, Auditing, GCP , ISO and Medical Devices regulationsI successfully completed course “ISO 9001:2000 Auditor/ Lead Auditor” of International Register of Certified Auditors (Certificate no’ 3914) and serve as auditor for European Notified Bodies, local and international pharmaceutical companies and CROs.I also serve as an active member of the quality forum for CTrials - the Israeli Association for the Advancement of Biomedical Research CommunityLanguages: English, Russian, HebrewSpecialties: auditing, communication skills, consulting, forms, SOP, GCP, ISO 13485, ISO 9000, ISO 14155, lecturer, meeting facilitation, presentation skills, protocols, quality, risk management, supervisory skills, team management, training programs,