Yossi Sabov's Linkedin Analytics

1. Validation expertise: - Thermal validation - Tanks SIP, Autoclaves (program, load development and performance) -FEDEGARI and TUTTNAUER, Ovens, Lyophilization, QC equipment (Incubators, Refrigirators, Freezers). -Tanks mixing - solution homogeneity, pasteurization. - Thermal validation equipment: Validator 2000 system (Kaye),TempTale, DATATRACE. - Calibaration. - Shipping validation (GDP). 2. Experienced with writing, implementing and approval of: Validation documents: Urs, DQ, IQ, OQ, PQ. Change Control. CAPA plan. Risk assessment/management. P&ID's. 3. Performance of audits (internal and supplier audit). 4. Presenting validation files during regulatory audits (e.g. FDA, Israeli health ministry ...). 5. Validation deviation management (opening, analysis and approval) and professional consulting in equipment and utilities deviations occurred during routine production. 6. Accompanying equipment and utilities projects.