Method of examination: Course work
Credit points: 5

Module Head: Dr. Ehrhard Anhalt, Dipl. Ing. Claudia Koban, Prof. Dr. Harald G. Schweim

Topics

Quality assurance

The role of Quality in the Pharmaceutical Industry Quality Management (QM), Quality Assurance (QA), Quality Control (QC) in the Pharmaceutical Industry Distinction between QM, QA and QC Overview on QM-Systems and Models Overview on QA Systems GMP, GCP, GLP Differences and mutualities Quality Systems Overview Organization, Responsibilities of Qualified Person (QP), Head Manufacturing and Head Quality Control Unit Change Control Documentation/Archiving Validation, Qualification, Validation Master Plan Deviation Management, Handling of Out-of-Specification Results (OOS) Corrective And Preventive Actions (CAPA) Training Internal Audits and Inspections Environmental Monitoring, Hygiene Product Release Quality Management Review Product Quality Review Quality Risk Management

Medical Devices What is a medical device Mode of action medicinal product vs medical device Basics and systematics of medical device legislation (new approach, notified bodies, channels of distribution) Preconditions before putting on the market (essential requirements, classification, conformity assessment procedures, CE labelling) Drug-Device combination Clinical investigation Medical device vigilance Quality managament (ISO CEN 13485)