Rita Gabay Msc, Cqa, Mrqa Email & Phone Number

Haifa Area, Israel

QA INSIGHT Ltd. offers unique combination of clinical background and expertise in GCP, QA education and expertise in ISO 9000 and 13485 and formal Quality Auditor training by international organization (International Register of Certified Auditors). With over 20 years of experience covering Quality Systems management and auditing in clinical research departments and manufacturing facilities QA INSIGHT possesses all skills and capacities needed to provide practical, professional and high-quality solutions for clients seeking for out-sourcing of auditing and QA consulting activities, all timely and at a very reasonable and competitive rate.Among our clients are INTERTEK in ISO 13485 area and PAREXEL in GCP area.We provide any kind of audits: GCP and ISO 14155 (in-house and sites), Clinical Department audits, vendor audits, mock audits, GDP audits and ISO 13485 audits.In addition we have a capacity for:- System analysis process- Clinical protocols writing- Clinical trials monitoring and management- Assisstance in establishment and maintenance of quality systems: Medical Devices Companies (ISO 13485 compliant), CROs and Clinical Departments (ISO 9001 compliant)- Preparation and submission to FDA of 510K and PMA Files for medical devices

Preparation of 510(k) submission and CE Technical Files Establishment of GCP compliant Clinical Trials SystemWriting of Clinical Trial Protocols, Amendments, Informed Consent Forms and designed CRFs.Management of Multicenter Clinical TrailsTeam Management

Establishment, maintenanace and implementation of Quality System at the local departmentPerformance of 1st and 2nd party Audits, as well as Clinical Trials Audits Training and update of the team regarding ICH GCP guidelines, regulatory requirements (FDA, EU and local), company and local SOPs. Consulting staff.Training of investigators on GCP requirements. Participation in Investigators' Meetings (including presentations) in Israel and abroad.As Clinical Supplies Logistic - Management of international study (six participating countries, forty sites

Association with Opinion LeadersReview and processing of relevant scientific information.Determination of marketing strategies.Management of scientific staff meetings and training of Medical Representatives.Participation in international conventions

Certificate, Auditing

Diploma, Management Of Marketing

M.Sc., Quality Assurance And Reliability

B.A., Nursing