phil cloud (5 Ergebnisse)

Gebunden. Zustand: New. Phil CloudAll current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do no.

Buch. Zustand: Neu. Neuware - Focusing specifically on the FDA documentation requirements, How to Develop and Manage Qualification Protocols for FDA Compliance provides readers with concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure that their companies are not at risk. It discusses key function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates readers can use as their own. Numerous diagrams and graphics are used to illustrate key points.

Zustand: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Zustand: New. Phil CloudWhile FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives de.

Buch. Zustand: Neu. Neuware - Comprehensively covering equipment qualification and process validation for pharmaceutical process equipment, this text shows readers how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. The author delineates how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst-case scenario. The thirty-eight completed protocol templates cover specific equipment types, provide instant answers to most protocol writing and testing questions, show how to qualify each piece of equipment, and provide a check for readers' own protocols.