Beskrivelse
This book is for both Auditor and Auditee in EU GDP API & Medicinal Product Distribution organizations.
"Practical EU GDP Audit Checklist and GAP Analysis"
Being an EU GDP Auditor in pharmaceutical industries, you must prepare a checklist. As a pharmaceutical organization being the Auditee or planning to host any inspection (Competent Authorities, Customer Audit, or Third Parties), you need to perform a GDP GAP Analysis of QS against standard ( based on WHO guidelines and EMA EudraLex Vol.4) to make sure you comply with requirements.
Suppose you are a Responsible Person (RP) and part of an Internal Inspection QA team, a private Quality Consultant Services to pharmaceutical distribution organizations, or a GDP Lead Auditor or Business Developer. In that case, this is a handy and practical tool for you. Continual improvement is a critical part of quality professionals in all industries. A Good Distribution Practice (GDP) requires solid knowledge management and training regarding personnel competence.
Yderligere information
| Forfatter(e) | Dorna Sheikhi |
|---|---|
| Kategori | Bøger |
| Genre(r) | Fagbøger |
| Forlag | Saxo Publish |
| Udgivelsesdato | Er udgivet |
| Sprog | Engelsk |
| ISBN-13 | 9788771963182 |
| ISBN-10 | 8771963189 |
| Indbinding | Paperback |
| Udgave | 1 |
| Sidetal | 79 |
| Tags | Gdp, Warehouse, Distributor, Storage, Medicinal, Drug, Api, Practical Gap Analysis & Audit Checklist, Bøger, Bog |
| GPSR | Produktsikkerhed |
