The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.
• Unique volume covering FDA inspections of GLP facilities
• Provides a detailed interpretation of GLP Regulations
• Presents the latest on electronic data management in GLP
• Describes GLP and computer systems validation
• Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Zahle einfach mit Karte, Klarna, Apple Pay oder Google Pay. Nicht zufrieden? Du hast immer ein 14-tägiges Widerrufsrecht. Lies mehr in unseren AGB. Hast du Fragen, schreib uns eine E-Mail an hello@memmo.org.
Memmo macht das Lernen einfacher – wo auch immer du bist. Bei uns findest du deine Kursbücher und smarte Lerntools an einem Ort: Zusammenfassungen, Quizzes, Podcasts und Lernkarten. Und Ted, dein Lernbuddy, beantwortet alles, was du wissen möchtest. Über 50.000 Studierende lernen bereits hier – gemacht, damit du schneller lernst und weniger Stress hast.