Preparing for FDA Pre-Approval Inspections e-bog
509,93 DKK
(inkl. moms 637,41 DKK)
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
E-bog
509,93 DKK
Forlag
CRC Press
Udgivet
19 april 2016
Længde
304 sider
Genrer
MMG
Sprog
English
Format
epub
Beskyttelse
LCP
ISBN
9781000654370
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th