实际实践中的过程验证-来自德国医院的案例研究

PROCESS VALIDATION IN REAL PRACTICE -A CASE STUDY FROM A GERMAN HOSPITALName: Bianca WinklerAffiliation: Head of QM in CSSD of RoMed Clinic (Rosenheim & Bad Aibling) in South Bavaria, GermanyAgenda1.Presentation of the RoMedGroup2.Validation –What’s that ?3.Why we do process validation4.Which processes do we validate ?5.How we do that ? 4 Main steps in Validation processes in practice6.Take a Look into the Validation Process of the CSSDs in RoMedBianca Winkler -Process Validation in a real Practice21. Presentation of the RoMed GroupSource: https://www.stepmap.de/landkarte/deutschland-blau-in-europa-FyG2dyiweZ-i, Upload 25.10.2024Source: https://www.stepmap.de/landkarte/Bayern-139343.png, Upload 20.04.2024Source: RoMed, Upload 20.04.2024GermanyState ofBavariaDistrict ofRosenheimBianca Winkler -Process Validation in a real Practice3With over 1,000 beds, we care for around 50,000 inpatients and 90,000 outpatients every year in our four municipal RoMedclinics in Bad Aibling, Prien am Chiem