Téléchargez le livre : Laboratory Control System Operations in a GMP Environment

Laboratory Control System Operations in a GMP Environment



de

Éditeur :

Wiley


Paru le : 2020-04-27



eBook Téléchargement , DRM LCP 🛈 DRM Adobe 🛈
Lecture en ligne (streaming)
148,70 €
Téléchargement immédiat
Dès validation de votre commande
Ajouter à ma liste d'envies
Image Louise Reader présentation

Louise Reader

Lisez ce titre sur l'application Louise Reader.

badge apple Application Louise Reader
badge Android Application Louise Reader
Description

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations
In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System.
Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices.  Additionally, a chapter outlining Stability Program operations is included in the text.
In addition to these topics, it includes LCS information and tools such as:
?      End of chapter templates, checklists, and LCS guidance to help you follow the required standards
?      Electronic versions of each tool so users can use them outside of the text
?      An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems
For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.
Pages
320 pages
Collection
n.c
Parution
2020-04-27
Marque
Wiley
EAN papier
9781119529231
EAN PDF
9781119529279
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
320
Taille du fichier
3953 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
148,70 €
EAN EPUB
9781119529293
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
320
Taille du fichier
14725 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
148,70 €

Suggestions personnalisées