Format:
1 online resource (352 pages)
ISBN:
9781003202868
,
1003202861
,
9781000550689
,
1000550680
,
9781000550665
,
1000550664
Content:
Chapter 1: About this bookChapter 2: IntroductionChapter 3: What to know before getting startedChapter 4: Getting startedChapter 5: Writing the quality manualChapter 6: Writing the Standard Operating ProceduresChapter 7: QMS documentation (SOP-1)Chapter 8: CAPA, monitoring & improvement (SOP-2)Chapter 9: Infrastructure (SOP-3)Chapter 10: Human resources (SOP-4)Chapter 11: Suppliers & distributors (SOP-5)Chapter 12: Auditing (SOP-6)Chapter 13: Communication, marketing & sales (SOP-7)Chapter 14: Risk management (SOP-8)Chapter 15: Clinical evidence (SOP-9)Chapter 16: Product realization (SOP-10)Chapter 17: Regulatory affairs (SOP-11)Chapter 18: Post-market surveillance (SOP-12)Chapter 19: Finalizing all the SOPsChapter 20: Writing templates, forms, records, and registriesChapter 21: Writing meeting agendas and minutesChapter 22: QMS software validationChapter 23: The launchChapter 24: TrainingChapter 25: Document reviewChapter 26: AuditsChapter 27: Management reviewChapter 28: CertificationChapter 29: Business as usualChapter 30: What to know when you are up and runningChapter 31: Conclusion
Additional Edition:
ISBN 9781032065748
Additional Edition:
ISBN 9781032065731
Additional Edition:
Erscheint auch als Druck-Ausgabe ISBN 9781032065748
Language:
English
DOI:
10.4324/9781003202868
