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Caduceum Academy
Medical Devices
Understanding the requirements of the ISO 13485 standard
Understanding the requirements of regulation 2017/745/EU
Transition from directive 93/42/EEC to regulation 2017/745/EU
Medical device single audit program – MDSAP, preparing and passing one’s audit
Discovering the quality and regulatory requirments of the ISO 14971 standard
Applying usability engineering to the use of medical devices, pursuant to the IEC 62366 standard
Analysing the IEC 62304 standard with regard to medical devices software
Electrical safety and electromagnetic compatibility of medical devices with regard to the IEC 60601-1 standard
Discovering FDA 21 CFR Part 820 requirements for medical devices
Regulation and quality requirements of medical devices in USA
Regulation and quality requirements of medical devices in Canada
Medical Devices for in-vitro diagnostics
Transition from directive 98/79/EC to regulation 2017/746/EU
Pharmaceutical
Good manufacturing practices requirements and application
Qualification/Validation according to Annex 15 of good manufacturing practices
Manfacturing of sterile medications according to Annex 1 of Good Manufacturing Practices
Mastering EU Regulations on medications for human use
Management of deviations and CAPAS
Mastering application of Good Clinical Practices (GCP)
Mastering application of Good Clinical and Laboratory Practices (GCLP)
IT Systems
Data Integrity: regulatory compliance and controlling corporate data assets
Defining and examining IT changes introduced by the ISO 13485 standard
Raising awareness of IT System Validation
Introduction to IT System Validation
IT System Validation training
Qualification of computing infrasctructures
Cross-Functional
Project management basics
Validation of special procedures
Statistics and sampling plan concepts
Mastering internal audit methods and tools
“Anti-gift” law and transparency, understanding applicable rules
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