1st Edition
How to Develop and Manage Qualification Protocols for FDA Compliance
By Phil Cloud
Copyright 1999
386 Pages
by
CRC Press
All 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. How to Develop and Manage Qualification Protocols for FDA Compliance... Read more
Introduction. Documentation Master Lists. Protocol Format and Style Guide. Protocol Writing Through Approval. Qualification Testing Through Certification. Change Control. Requalification. Document Control. Electronic Documentation Database. Appendices. Index.
Biography
Phil Cloud
