Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 07 (WS 2017 / SS 2018)

Quality management / medical devices

attendance approx. Seminar Paper Method of examination Credit
approx. 30 h approx. 30 h seminar paper 5

Module Supervisor

  • Dipl. Ing. Claudia Koban, Wien
  • Dr. Ehrhard Anhalt, Bonn

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)

Study plan

Part 1:
Friday   16 March 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   17 March 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Uni-Club
Part 2:
Friday   23 March 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   24 March 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Haus der evang. Kirche, Adenauerallee 37, Bonn
     
    Deadline seminar paper: 23 April 2018

DocumentationOnly for members

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