How to Develop and Manage Qualification Protocols for FDA Com... - 9781574910988

How to Develop and Manage Qualification Protocols for FDA ComplianceAuthor(s): Phil Cloud\nFormat: Hardback\nPublisher: Taylor & Francis Inc, United States\nImprint: CRC Press Inc\nISBN-13: 9781574910988, 978-1574910988\nSynopsis\nAll 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 not provide guidelines on how to produce documentation such as qualification protocols.\n\nHow to Develop and Manage Qualification Protocols for FDA Compliance focuses specifically on the FDA documentation requirements, providing concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure your company is not at risk.\n\nKey function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process are discussed in detail. The book co.