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
- Qualitätssicherung / Dokumentation
- Regulatory Affairs and Compliance
- Entwicklung / Prüfpräparate
- Datenintegrität
- Qualitätskontrolle / Analytik / Statistik
- GDP - Lager - Logistik
- Computervalidierung
- Validierung / Qualifizierung
- GMP in Produktion / Technik
- GMP für Wirkststoffe und Hilfsstoffe
- Medizinprodukte und Kosmetika
- GMP Basisausbildung
- Packmittel / Verpackung
- Hygiene / Mikrobiologie / Steril
- Biotechnologie
- Einkauf / Betriebswirtschaft / Effizienz
- European Conferences and Education Courses
- Sonstige Themen