实际实践中的过程验证 - 来自德国医院的案例研究.pdf

1、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,GermanyAgendaAgenda1.1.Presentation of the Presentation of the RoMedRoMed GroupGroup2.2.Validation Validation Whats that?Wha

2、ts that?3.3.Why we do process validationWhy we do process validation4.4.Which processes do we validate?Which processes do we validate?5.5.How we do that?4 Main steps in Validation processes in How we do that?4 Main steps in Validation processes in practicepractice6.6.Take a Look into the Validation

3、Process of the CSSDs in Take a Look into the Validation Process of the CSSDs in RoMedRoMedBianca Winkler-Process Validation in a real Practice21.Presentation of the RoMed Group1.Presentation of the RoMed GroupSource:https:/www.stepmap.de/landkarte/deutschland-blau-in-europa-FyG2dyiweZ-i,Upload 25.10

4、.2024Source:https:/www.stepmap.de/landkarte/Bayern-139343.png,Upload 20.04.2024Source:RoMed,Upload 20.04.2024GermanyState of BavariaDistrict 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

5、our four municipal RoMed clinics in Bad Aibling,Prien am Chiemsee,Rosenheim and Wasserburgam Inn.Around 3,000 employees look after the well-being of our patients around the clock.Bianca Winkler-Process Validation in a real Practice4RoMed RoMed ClinicsClinicsBianca Winkler-Process Validation in a rea

6、l Practice5RosenheimRosenheim-a maximum care hospital.Illnesses from the eyes to the toes are treated here at the highest level.With 622 beds and 2,000 employees,the RoMed Hospital Rosenheim is the largest hospital in the RoMed clinic network.Specialist departments are:certified Chest Pain Unit and