Academy
Benefit from Our Expertise
At Normec Valitech Academy, we train not only our own employees but also external participants in the field of validation. In collaboration with various educational institutions in Germany, we offer training courses aimed at validators, reprocessing staff, medical device manufacturers, authorities, and other interested professionals.
Performance qualifications/assessments for reprocessing processes of medical devices for validators in accordance with the Medical Devices Operator Ordinance (MPBetreibV)
Valitechis an official partner of theBrandenburg Educational Institute for Medicine and Social Affairs e.V.for the“Validator Training Course according to the DGSV® Framework Curriculum.”
Target Group
Validators for processes in large and small steam sterilizers in healthcare facilities, interested employees from industry and medical technology, dental depots, and dental/medical practices.
Admission Requirements
A “suitable vocational qualification” as defined by the current Medical Devices Operator Ordinance (e.g. technical professions)
Completion ofModule Vali A, including documentation of a 2-day (16 hours) job-shadowing experience in a CSSD (AEMP)
Completion ofModule Vali B, including: – Proof of successful participation inModule Vali A – Basics of Medical Device Reprocessingat an institution recognized by the DGSV to conduct specialized or practical courses,or– Proof of participation in aSpecialist Course Ior aBasic Course for Medical/Dental Practiceat a DGSV-recognized educational institutionand– Proof of device-specific knowledge for large and small steam sterilizers used in healthcare facilities
Course Content
Module Vali A – Basics of Medical Device Reprocessing
Personal hygiene and environmental hygiene
Reprocessing of medical devices
Quality management and validation
Module Vali B – Performance Qualification of Reprocessing Processes
Basics of validation of reprocessing processes
Responsibilities of the validator
Organizational, communication, and documentation aspects
Process qualification within the scope of validation in healthcare facilities
Module Vali C – Performance Qualification of Cleaning and Disinfection Processes
Risk management during performance qualification
Creation of process flow diagrams
Execution of performance qualification
Tasks after performance qualification
Validation reports
Module Vali E – Performance Qualification of Processes in Large and Small Steam Sterilizers
Risk management during performance qualification
Creation of process flow diagrams
Execution of performance qualification
Tasks after performance qualification
Validation reports
Registration
All information about current dates, participation fees, registration, etc. can be obtained from the Brandenburg Educational Institute for Medicine and Social Affairs e.V.
www.bbwev.de Tel: +49 331 96722-29