Practical GAP Analysis & Audit Checklist
- EU Good Distribution Practice (GDP) API, Medicinal Product & WHO
- Indbinding:
- Paperback
- Sideantal:
- 79
- Udgivet:
- 11. februar 2023
- Udgave:
- 1
- 2-4 uger.
- 16. december 2024
På lager
Normalpris
Abonnementspris
- Rabat på køb af fysiske bøger
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
Beskrivelse af Practical GAP Analysis & Audit Checklist
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.
"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.
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