Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers
Titel:
Quality Management System – Medical Devices –
Guidance on the Control of Products and Services
Obtained from Suppliers
Herkunft/Verlag:
GHTF
Dokumentenart:
Guideline
Inhalt:
This guidance document is intended for medical device manufacturers and it is expected that the
reader is familiar with regulatory quality management system requirements within the medical
devices sector. This guidance document may also be useful to regulatory authorities and
suppliers. This guidance document is intended for educational purposes and it is not intended to
be used to assess or audit compliance with regulatory requirements.
GMP Seminare nach Thema
- Allgemeine QA Themen + GMP Compliance
- Regulatory Affairs
- Development
- Datenintegrität
- Analytik allgemein
- Good Distribution Practice
- Computervalidierung
- Validierung allgemein
- Pharma Engineering allgemein
- API/Wirkststoffe/Hilfsstoffe
- Medizinprodukte und Combination Products
- GMP Grundlagen / Basis-Seminare
- Verpackung und Packmittel
- Hygiene
- Biotechnologie/Blut/ATMP
- Sachkundige Person (QP)
- European Conferences and Education Courses
- Sonstiges
- GMP Audits
- Dokumentation
- Reinigungsvalidierung
- IT allgemein
- Verunreinigungen/Impurities
- OOS / OOT / OOE
- Rohstoff-Prüfung
- Methodenvalidierung
- Gerätequalifizierung
- Stabilitätsprüfung
- Allgemeine mikrobiologische Themen
- Mikrobiologische Tests
- Technik
- Herstellung allgemein
- Sterile Herstellung
- Feste/halbfeste Formen
- Phytopharmaka/Cannabis/Radiopharmazeutika