Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units
Titel:
Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units
Kurztitel:
Annex V
Herkunft/Verlag:
European Commision
Dokumentenart:
Guidance
Inhalt:
The purpose of this document is to provide guidance for the preparation of GCP inspections conducted in Phase I Units. The points to consider in this document are specific to these types of units and other guidance documents should be referred to
for consideration of those areas common to other types of inspections, e.g. computer systems, archiving and quality systems.
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