Computer systems validation: quality assurance, risk management, and regulatory compliance for pharmaceutical and healthcare companies
Éditeur :
Taylor & Francis Inc
ISBN :
9780849318719
Date de publication :
18 déc. 2003
Dimensions :
25,4 x 17,8 cm
Poids :
2070 g
Langue :
Anglais
Pays d'origine :
USA
A discussion of good laboratory, clinical, manufacturing and distribution practices, this text explains the regulatory developments for the US FDA and other regulatory authorities. Examples and checklists appear throughout, with an exploration of the role of quality assurance and risk management as components of pragmatic regulatory compliance.