How to Develop and Manage Qualification Protocols for FDA Compliance

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. The author 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.